User login
Type 2, Gestational Diabetes Are Genetically Linked
WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.
Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting. Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well.”
While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.
“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.
“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”
Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.
The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.
An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.
It is findings like these that may, with further research, lead to future recommendations for genetic screening.
Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)
In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight. “Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carb diet, because the baby needs a high glucose level.”
Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.
In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors). Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin.
Dr. Shuldiner reported that he had no relevant financial disclosures.
WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.
Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting. Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well.”
While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.
“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.
“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”
Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.
The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.
An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.
It is findings like these that may, with further research, lead to future recommendations for genetic screening.
Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)
In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight. “Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carb diet, because the baby needs a high glucose level.”
Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.
In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors). Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin.
Dr. Shuldiner reported that he had no relevant financial disclosures.
WASHINGTON – Most of the gene variations identified thus far as risk factors for type 2 diabetes also appear to increase risk for gestational diabetes – a trend that reaffirms the importance of taking family histories in obstetrical practice, Dr. Alan R. Shuldiner said.
Hundreds of candidate genes for type 2 diabetes have been analyzed in association studies over the past several years, and more recently, whole genome approaches have identified close to 40 genes with variations that increase the risk of type 2 diabetes, he explained at the meeting. Moreover, “most of these genetic variants that have also been looked at in [studies of] gestational diabetes all seem to increase risk there as well.”
While the utility of genetic screening in obstetrics needs to be investigated, it's clear that “people who have a family history of type 2 diabetes are probably at increased risk for gestational diabetes,” he said in an interview.
“From a genetic point of view, recent research reaffirms the importance of clinicians asking about family history,” said Dr. Shuldiner, who directs the program in personalized medicine and chairs the division of endocrinology, diabetes, and nutrition at the University of Maryland, Baltimore.
“Until recently, we really didn't know [about this interface],” he said. “It was possible that the genetic factors contributing to gestational diabetes would be very different and distinct from those contributing to type 2 diabetes. So far, that appears not to be the case.”
Most recently, an analysis of more than 5,500 pregnant women participating in the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study demonstrated that a common maternal variant of the TCF7L2 gene is associated with a higher risk of gestational diabetes, as defined by the new International Association of Diabetes and Pregnancy Study Groupshand thus a higher risk of adverse pregnancy outcomes, he told meeting participants.
The risk-conferring variants of the TCF7L2 gene appear to be associated with impaired beta-cell function rather than insulin resistance, he noted.
An earlier report on TCF7L2 polymorphisms and progression to diabetes from the Diabetes Prevention Program Research Group showed that patients with the TCF7L2 variant are at increased risk of developing diabetes but “may be superresponders to lifestyle interventions,” Dr. Shuldiner said.
It is findings like these that may, with further research, lead to future recommendations for genetic screening.
Growing evidence on the effects of mutations in the glucokinase (GCK) gene, which appear to account for approximately 5% of gestational diabetes cases in white mothers, may similarly drive screening efforts in the future, he said. (Glucokinase is an enzyme present in pancreatic beta cells required for proper glucose sensing and insulin secretion.)
In a small study conducted in the United Kingdom, maternal hyperglycemia due to a GCK mutation – with no GCK mutation in the fetus – has been shown to result in higher birth weights, while inheritance by the fetus of a paternal GCK mutation appears to result in significant reductions in birth weight. “Screening for GCK mutations could potentially be useful in guiding therapy so that the baby has a normal birth weight,” said Dr. Shuldiner, also John L. Whitehurst Professor of Medicine and professor of physiology. “The data so far suggest that if both mom and the fetus have a GCK mutation, you may want to forego treatment [with oral hypoglycemic agents or insulin], and even put mom on a high-carb diet, because the baby needs a high glucose level.”
Glucokinase mutations are also associated with maturity-onset diabetes of the young (MODY), which begins before the age of 25 and which we “now know is a heterogeneous group of disorders” resulting in mutations in any of at least eight different genes, he said.
In fact, many experts refer to MODY as being either “glucokinase diabetes” (resulting from mutations in the gene that encodes the glycolytic enzyme glucokinase) or “transcription factor diabetes” (resulting from mutations in genes that encode various transcription factors). Unlike GCK MODY, transcription factor MODY is characterized by hyperglycemia that progressively worsens and often requires treatment with oral hypoglycemic agents or insulin.
Dr. Shuldiner reported that he had no relevant financial disclosures.
Expert Analysis from the Annual Meeting of the Diabetes in Pregnancy Study Group of North America
Experts Debate Insulin Analogue Use in Pregnancy : While the analogues appear safe, there is reason to be cautious until more data are available.
WASHINGTON – Short-acting insulin analogues appear to be safe in insulin-requiring pregnancies and have clinical advantages, including increased freedom of meal timing, better matching of insulin dose with meal content, and improved glycemic control with a reduction in the frequency of hypoglyemic events, said Dr. Marshall W. Carpenter.
The analogues lispro (Humalog) and aspart (Novolog) may be advantageous, for instance, for the pregnant woman “with a toddler around who may not know when she is going to sit down to eat,” Dr. Carpenter said at the meeting.
“The benefit is reflected in the [higher, faster] peak insulin values seen with both lispro and aspart compared with human insulin,” said Dr. Carpenter of the department of obstetrics and gynecology at Tufts University, Boston.
Dr. Virginia R. Lupo, who chairs the department of obstetrics and gynecology at the Hennepin County Medical Center in Minneapolis, offered a different take on the utility of short-acting insulin analogues.
Diabetes disproportionately affects women who have annual household incomes below $25,000 and who are more likely to be black, Hispanic, American Indian, or Asian Pacific Islanders than white, she said. For many of these women, a regimen including short-acting insulin analogues is too complex for their lifestyle, eating habits, functional health literacy, and other life circumstances.
“A lot of my patients eat by grazing – there are no distinct meal times,” she said. And because of evening-long food availability and ingestion, these patients “require elevated basal insulin through the evenings.”
“I'm not convinced that insulin analogues are the right way to go,” she said. “I like the idea of NPH twice a day, before breakfast and before supper. It's better to take [insulin] twice a day than not take it five times a day.”
The utility of long-acting insulin analogues in pregnancy, Dr. Carpenter said, is still uncertain considering the lack of substantive real-life clinical experience with these analogues and the safety implications raised in the literature thus far. “And really,” he added in an interview after the meeting, “there's no evidence that glargine (Lantus) offers any benefit over NPH insulin – and NPH insulin is cheaper.”
Questions about the safety of analogues overall stem from the molecular modifications involved in their creation, and specifically the implications of modifying the C-terminal end of the insulin beta chain. Such modifications appear to increase affinity for the insulinlike growth factor–1 (IGF-1) receptor – a receptor that has “a broad array of effects,” from induction of mitogenesis and inhibition of apoptosis, to stimulation of angiogenesis, he said.
Analogues' increased “stimulation of [this receptor] has thus appropriately raised concerns about safety,” he said.
While the current safety profile of the short-acting analogues “suggests no independent effect on retinopathic change or carcinogenesis,” there is reason to be cautious about long-acting analogues until more data are available, he said.
A study published in 2000 comparing the toxicopharmacologic properties of insulin analogues showed that glargine had a six- to eightfold increase in IGF-1 receptor affinity and associated mitogenic potency compared with human insulin, he noted. The two rapidly acting insulin analogues resembled human insulin on all parameters, except for a slightly elevated IGF-1 receptor affinity for lispro (Diabetes 2000;49:999–1005).
A possible association of lispro with proliferative retinopathy was “put on the map” more than a decade ago when Dr. John L. Kitzmiller and his colleagues reported that 3 out of 10 lispro-treated patients with no detected background retinopathy progressed to proliferative retinopathy during pregnancy (Diabetes Care 1999;22:874–5), Dr. Carpenter said.
Studies and commentary since then have shown no adverse impact of insulin analogues on the progression of diabetic retinopathy in pregnant patients, he said. A Finnish study of 69 pregnant women treated with either lispro or conventional human insulin, for instance, showed no significant differences in retinopathy progression (Diabetes Care 2003;26:1193–8).
Experts have also noted that the hemaglobin A1c levels in women in Dr. Kitzmiller's series were initially high, indicative of poor prepregnancy metabolic control, which raises the question of whether the rapid change to euglycemic control may have been the primary contributor to the advancing retinopathy among these patients rather than a specific lispro effect.
Regardless of insulin choice, rapid tightening of glycemic control is among the predictors of proliferative diabetic retinopathy during pregnancy, along with the duration of diabetes, HbA1c or plasma glucose at the onset of care, and other factors, he said. “We really ought to have informed consent for the rapid achievement of normal blood sugars from a nonpregnant state to a pregnant state … for patients who are in denial before becoming pregnant, with very poor metabolic control, and who are then enlisted in very careful management to dramatically improve their glycemic control,” Dr. Carpenter said in an interview. “These are the patients we know are at risk of worsening retinopathy.”
Dr. Lupo and Dr. Carpenter said they had no relevant financial disclosures.
WASHINGTON – Short-acting insulin analogues appear to be safe in insulin-requiring pregnancies and have clinical advantages, including increased freedom of meal timing, better matching of insulin dose with meal content, and improved glycemic control with a reduction in the frequency of hypoglyemic events, said Dr. Marshall W. Carpenter.
The analogues lispro (Humalog) and aspart (Novolog) may be advantageous, for instance, for the pregnant woman “with a toddler around who may not know when she is going to sit down to eat,” Dr. Carpenter said at the meeting.
“The benefit is reflected in the [higher, faster] peak insulin values seen with both lispro and aspart compared with human insulin,” said Dr. Carpenter of the department of obstetrics and gynecology at Tufts University, Boston.
Dr. Virginia R. Lupo, who chairs the department of obstetrics and gynecology at the Hennepin County Medical Center in Minneapolis, offered a different take on the utility of short-acting insulin analogues.
Diabetes disproportionately affects women who have annual household incomes below $25,000 and who are more likely to be black, Hispanic, American Indian, or Asian Pacific Islanders than white, she said. For many of these women, a regimen including short-acting insulin analogues is too complex for their lifestyle, eating habits, functional health literacy, and other life circumstances.
“A lot of my patients eat by grazing – there are no distinct meal times,” she said. And because of evening-long food availability and ingestion, these patients “require elevated basal insulin through the evenings.”
“I'm not convinced that insulin analogues are the right way to go,” she said. “I like the idea of NPH twice a day, before breakfast and before supper. It's better to take [insulin] twice a day than not take it five times a day.”
The utility of long-acting insulin analogues in pregnancy, Dr. Carpenter said, is still uncertain considering the lack of substantive real-life clinical experience with these analogues and the safety implications raised in the literature thus far. “And really,” he added in an interview after the meeting, “there's no evidence that glargine (Lantus) offers any benefit over NPH insulin – and NPH insulin is cheaper.”
Questions about the safety of analogues overall stem from the molecular modifications involved in their creation, and specifically the implications of modifying the C-terminal end of the insulin beta chain. Such modifications appear to increase affinity for the insulinlike growth factor–1 (IGF-1) receptor – a receptor that has “a broad array of effects,” from induction of mitogenesis and inhibition of apoptosis, to stimulation of angiogenesis, he said.
Analogues' increased “stimulation of [this receptor] has thus appropriately raised concerns about safety,” he said.
While the current safety profile of the short-acting analogues “suggests no independent effect on retinopathic change or carcinogenesis,” there is reason to be cautious about long-acting analogues until more data are available, he said.
A study published in 2000 comparing the toxicopharmacologic properties of insulin analogues showed that glargine had a six- to eightfold increase in IGF-1 receptor affinity and associated mitogenic potency compared with human insulin, he noted. The two rapidly acting insulin analogues resembled human insulin on all parameters, except for a slightly elevated IGF-1 receptor affinity for lispro (Diabetes 2000;49:999–1005).
A possible association of lispro with proliferative retinopathy was “put on the map” more than a decade ago when Dr. John L. Kitzmiller and his colleagues reported that 3 out of 10 lispro-treated patients with no detected background retinopathy progressed to proliferative retinopathy during pregnancy (Diabetes Care 1999;22:874–5), Dr. Carpenter said.
Studies and commentary since then have shown no adverse impact of insulin analogues on the progression of diabetic retinopathy in pregnant patients, he said. A Finnish study of 69 pregnant women treated with either lispro or conventional human insulin, for instance, showed no significant differences in retinopathy progression (Diabetes Care 2003;26:1193–8).
Experts have also noted that the hemaglobin A1c levels in women in Dr. Kitzmiller's series were initially high, indicative of poor prepregnancy metabolic control, which raises the question of whether the rapid change to euglycemic control may have been the primary contributor to the advancing retinopathy among these patients rather than a specific lispro effect.
Regardless of insulin choice, rapid tightening of glycemic control is among the predictors of proliferative diabetic retinopathy during pregnancy, along with the duration of diabetes, HbA1c or plasma glucose at the onset of care, and other factors, he said. “We really ought to have informed consent for the rapid achievement of normal blood sugars from a nonpregnant state to a pregnant state … for patients who are in denial before becoming pregnant, with very poor metabolic control, and who are then enlisted in very careful management to dramatically improve their glycemic control,” Dr. Carpenter said in an interview. “These are the patients we know are at risk of worsening retinopathy.”
Dr. Lupo and Dr. Carpenter said they had no relevant financial disclosures.
WASHINGTON – Short-acting insulin analogues appear to be safe in insulin-requiring pregnancies and have clinical advantages, including increased freedom of meal timing, better matching of insulin dose with meal content, and improved glycemic control with a reduction in the frequency of hypoglyemic events, said Dr. Marshall W. Carpenter.
The analogues lispro (Humalog) and aspart (Novolog) may be advantageous, for instance, for the pregnant woman “with a toddler around who may not know when she is going to sit down to eat,” Dr. Carpenter said at the meeting.
“The benefit is reflected in the [higher, faster] peak insulin values seen with both lispro and aspart compared with human insulin,” said Dr. Carpenter of the department of obstetrics and gynecology at Tufts University, Boston.
Dr. Virginia R. Lupo, who chairs the department of obstetrics and gynecology at the Hennepin County Medical Center in Minneapolis, offered a different take on the utility of short-acting insulin analogues.
Diabetes disproportionately affects women who have annual household incomes below $25,000 and who are more likely to be black, Hispanic, American Indian, or Asian Pacific Islanders than white, she said. For many of these women, a regimen including short-acting insulin analogues is too complex for their lifestyle, eating habits, functional health literacy, and other life circumstances.
“A lot of my patients eat by grazing – there are no distinct meal times,” she said. And because of evening-long food availability and ingestion, these patients “require elevated basal insulin through the evenings.”
“I'm not convinced that insulin analogues are the right way to go,” she said. “I like the idea of NPH twice a day, before breakfast and before supper. It's better to take [insulin] twice a day than not take it five times a day.”
The utility of long-acting insulin analogues in pregnancy, Dr. Carpenter said, is still uncertain considering the lack of substantive real-life clinical experience with these analogues and the safety implications raised in the literature thus far. “And really,” he added in an interview after the meeting, “there's no evidence that glargine (Lantus) offers any benefit over NPH insulin – and NPH insulin is cheaper.”
Questions about the safety of analogues overall stem from the molecular modifications involved in their creation, and specifically the implications of modifying the C-terminal end of the insulin beta chain. Such modifications appear to increase affinity for the insulinlike growth factor–1 (IGF-1) receptor – a receptor that has “a broad array of effects,” from induction of mitogenesis and inhibition of apoptosis, to stimulation of angiogenesis, he said.
Analogues' increased “stimulation of [this receptor] has thus appropriately raised concerns about safety,” he said.
While the current safety profile of the short-acting analogues “suggests no independent effect on retinopathic change or carcinogenesis,” there is reason to be cautious about long-acting analogues until more data are available, he said.
A study published in 2000 comparing the toxicopharmacologic properties of insulin analogues showed that glargine had a six- to eightfold increase in IGF-1 receptor affinity and associated mitogenic potency compared with human insulin, he noted. The two rapidly acting insulin analogues resembled human insulin on all parameters, except for a slightly elevated IGF-1 receptor affinity for lispro (Diabetes 2000;49:999–1005).
A possible association of lispro with proliferative retinopathy was “put on the map” more than a decade ago when Dr. John L. Kitzmiller and his colleagues reported that 3 out of 10 lispro-treated patients with no detected background retinopathy progressed to proliferative retinopathy during pregnancy (Diabetes Care 1999;22:874–5), Dr. Carpenter said.
Studies and commentary since then have shown no adverse impact of insulin analogues on the progression of diabetic retinopathy in pregnant patients, he said. A Finnish study of 69 pregnant women treated with either lispro or conventional human insulin, for instance, showed no significant differences in retinopathy progression (Diabetes Care 2003;26:1193–8).
Experts have also noted that the hemaglobin A1c levels in women in Dr. Kitzmiller's series were initially high, indicative of poor prepregnancy metabolic control, which raises the question of whether the rapid change to euglycemic control may have been the primary contributor to the advancing retinopathy among these patients rather than a specific lispro effect.
Regardless of insulin choice, rapid tightening of glycemic control is among the predictors of proliferative diabetic retinopathy during pregnancy, along with the duration of diabetes, HbA1c or plasma glucose at the onset of care, and other factors, he said. “We really ought to have informed consent for the rapid achievement of normal blood sugars from a nonpregnant state to a pregnant state … for patients who are in denial before becoming pregnant, with very poor metabolic control, and who are then enlisted in very careful management to dramatically improve their glycemic control,” Dr. Carpenter said in an interview. “These are the patients we know are at risk of worsening retinopathy.”
Dr. Lupo and Dr. Carpenter said they had no relevant financial disclosures.
Expert Analysis from the Annual Meeting of the Diabetes in Pregnancy Study Group of North America
Pessaries Key to Stress Incontinence Management
WASHINGTON – Trials of vaginal and urinary inserts are worthwhile for managing stress urinary incontinence in women who are young, women with episodic leakage related to certain activities, or in women who – for various reasons – are not yet ready for a surgical repair or are at high risk from any invasive procedure, Dr. Deborah J. Lightner said.
“It's unfortunate, but many women currently manage their incontinence with pads,” said Dr. Lightner during a discussion of office-based management of stress urinary incontinence (SUI) at the meeting.
The mainstay of SUI management is still active pelvic floor muscle training that's taught and done correctly. But when this is unsuccessful, and when no neurologic abnormalities are detected, pessaries and other inserts – in some cases, a simple tampon – deserve consideration, she said. Research has shown that many women buy pads and tampons for the purposes of helping with urinary leakage and that three-quarters of women who use a tampon or other vaginal insert for mild SUI will be dry with that insert. “Many women know about tampons [for this purpose], but if not, you can offer them a very simple management strategy,” she said.
A tampon may be the best option, for instance, for a 24-year-old woman who leaks when playing soccer and only rarely at other times, especially if pelvic floor management training has provided no relief and if she is planning to have children. “This is an incredibly common scenario. [Urinary leakage] is a real barrier to women's participation in high-impact activities and sports,” said Dr. Lightner, a professor of urology at the Mayo Clinic in Rochester, Minn.
Pessaries are widely available and mainly used for prolapse, but there are a variety of “highly effective” incontinence rings and dishes that provide external compression of the bladder neck, Dr. Lightner said.
Early discontinuation of pessaries and other inserts “can be expected in about one-third of patients [who try them], but when [the inserts] are well tolerated, there's very high long-term success,” she said.
Among women who were randomized to use an intravaginal pessary in the Ambulatory Treatments for Leakage Associated With Stress Incontinence (ATLAS) trial, 63% were satisfied at 3 months, 33% had no bothersome SUI, and more than 50% had a greater than 75% reduction in their urinary leakage, she said. Results of the ATLAS trial were reported last year (Obstet. Gynecol. 2010;115:609–17).
Refitting of pessaries is not uncommon, she noted. (In the ATLAS trial, 47% of the patients assigned to the pessary group needing a refitting, and 92% were ultimately properly fitted.) Minor complications can also occur. In one retrospective study of 273 women fitted with a ring pessary, the rate of minor complications (vaginal bleeding, extrusion, severe vaginal discharge, pain, and constipation, in decreasing order) was a surprisingly high 56% (BJOG 2009;116:1715–21).
“Women will decide early on if this is the right option for them,” Dr. Lightner said. “And if it's not, they can move on to other therapies.”
Clinical experience over the past 2 decades with urethral inserts has been “somewhat challenging,” she said. Colonization and symptomatic urinary tract infections can occur with frequent or long-term use. Calcification and erosion also can occur, but “mainly with indwelling inserts, and not with episodic use.”
The reported continence rate with use of the FemSoft urethral insert – the only one currently available in the United States – is 93% at 48 months. Early discontinuation occurs in up to 40% of users, and UTIs occur in about one-third of patients. Still, with this “excellent” continence rate, the urethral insert may have a role for women who wish to postpone or avoid surgery, she said.
Pelvic floor muscle training – the first-line management option for SUI – is often inadequately taught to women, she emphasized. “It can't be effective it's not done correctly, so I'd have that as part of my physical exam … find out, what can she do with her pelvic floor?”
Dr. Lightner reported that she had no disclosures.
WASHINGTON – Trials of vaginal and urinary inserts are worthwhile for managing stress urinary incontinence in women who are young, women with episodic leakage related to certain activities, or in women who – for various reasons – are not yet ready for a surgical repair or are at high risk from any invasive procedure, Dr. Deborah J. Lightner said.
“It's unfortunate, but many women currently manage their incontinence with pads,” said Dr. Lightner during a discussion of office-based management of stress urinary incontinence (SUI) at the meeting.
The mainstay of SUI management is still active pelvic floor muscle training that's taught and done correctly. But when this is unsuccessful, and when no neurologic abnormalities are detected, pessaries and other inserts – in some cases, a simple tampon – deserve consideration, she said. Research has shown that many women buy pads and tampons for the purposes of helping with urinary leakage and that three-quarters of women who use a tampon or other vaginal insert for mild SUI will be dry with that insert. “Many women know about tampons [for this purpose], but if not, you can offer them a very simple management strategy,” she said.
A tampon may be the best option, for instance, for a 24-year-old woman who leaks when playing soccer and only rarely at other times, especially if pelvic floor management training has provided no relief and if she is planning to have children. “This is an incredibly common scenario. [Urinary leakage] is a real barrier to women's participation in high-impact activities and sports,” said Dr. Lightner, a professor of urology at the Mayo Clinic in Rochester, Minn.
Pessaries are widely available and mainly used for prolapse, but there are a variety of “highly effective” incontinence rings and dishes that provide external compression of the bladder neck, Dr. Lightner said.
Early discontinuation of pessaries and other inserts “can be expected in about one-third of patients [who try them], but when [the inserts] are well tolerated, there's very high long-term success,” she said.
Among women who were randomized to use an intravaginal pessary in the Ambulatory Treatments for Leakage Associated With Stress Incontinence (ATLAS) trial, 63% were satisfied at 3 months, 33% had no bothersome SUI, and more than 50% had a greater than 75% reduction in their urinary leakage, she said. Results of the ATLAS trial were reported last year (Obstet. Gynecol. 2010;115:609–17).
Refitting of pessaries is not uncommon, she noted. (In the ATLAS trial, 47% of the patients assigned to the pessary group needing a refitting, and 92% were ultimately properly fitted.) Minor complications can also occur. In one retrospective study of 273 women fitted with a ring pessary, the rate of minor complications (vaginal bleeding, extrusion, severe vaginal discharge, pain, and constipation, in decreasing order) was a surprisingly high 56% (BJOG 2009;116:1715–21).
“Women will decide early on if this is the right option for them,” Dr. Lightner said. “And if it's not, they can move on to other therapies.”
Clinical experience over the past 2 decades with urethral inserts has been “somewhat challenging,” she said. Colonization and symptomatic urinary tract infections can occur with frequent or long-term use. Calcification and erosion also can occur, but “mainly with indwelling inserts, and not with episodic use.”
The reported continence rate with use of the FemSoft urethral insert – the only one currently available in the United States – is 93% at 48 months. Early discontinuation occurs in up to 40% of users, and UTIs occur in about one-third of patients. Still, with this “excellent” continence rate, the urethral insert may have a role for women who wish to postpone or avoid surgery, she said.
Pelvic floor muscle training – the first-line management option for SUI – is often inadequately taught to women, she emphasized. “It can't be effective it's not done correctly, so I'd have that as part of my physical exam … find out, what can she do with her pelvic floor?”
Dr. Lightner reported that she had no disclosures.
WASHINGTON – Trials of vaginal and urinary inserts are worthwhile for managing stress urinary incontinence in women who are young, women with episodic leakage related to certain activities, or in women who – for various reasons – are not yet ready for a surgical repair or are at high risk from any invasive procedure, Dr. Deborah J. Lightner said.
“It's unfortunate, but many women currently manage their incontinence with pads,” said Dr. Lightner during a discussion of office-based management of stress urinary incontinence (SUI) at the meeting.
The mainstay of SUI management is still active pelvic floor muscle training that's taught and done correctly. But when this is unsuccessful, and when no neurologic abnormalities are detected, pessaries and other inserts – in some cases, a simple tampon – deserve consideration, she said. Research has shown that many women buy pads and tampons for the purposes of helping with urinary leakage and that three-quarters of women who use a tampon or other vaginal insert for mild SUI will be dry with that insert. “Many women know about tampons [for this purpose], but if not, you can offer them a very simple management strategy,” she said.
A tampon may be the best option, for instance, for a 24-year-old woman who leaks when playing soccer and only rarely at other times, especially if pelvic floor management training has provided no relief and if she is planning to have children. “This is an incredibly common scenario. [Urinary leakage] is a real barrier to women's participation in high-impact activities and sports,” said Dr. Lightner, a professor of urology at the Mayo Clinic in Rochester, Minn.
Pessaries are widely available and mainly used for prolapse, but there are a variety of “highly effective” incontinence rings and dishes that provide external compression of the bladder neck, Dr. Lightner said.
Early discontinuation of pessaries and other inserts “can be expected in about one-third of patients [who try them], but when [the inserts] are well tolerated, there's very high long-term success,” she said.
Among women who were randomized to use an intravaginal pessary in the Ambulatory Treatments for Leakage Associated With Stress Incontinence (ATLAS) trial, 63% were satisfied at 3 months, 33% had no bothersome SUI, and more than 50% had a greater than 75% reduction in their urinary leakage, she said. Results of the ATLAS trial were reported last year (Obstet. Gynecol. 2010;115:609–17).
Refitting of pessaries is not uncommon, she noted. (In the ATLAS trial, 47% of the patients assigned to the pessary group needing a refitting, and 92% were ultimately properly fitted.) Minor complications can also occur. In one retrospective study of 273 women fitted with a ring pessary, the rate of minor complications (vaginal bleeding, extrusion, severe vaginal discharge, pain, and constipation, in decreasing order) was a surprisingly high 56% (BJOG 2009;116:1715–21).
“Women will decide early on if this is the right option for them,” Dr. Lightner said. “And if it's not, they can move on to other therapies.”
Clinical experience over the past 2 decades with urethral inserts has been “somewhat challenging,” she said. Colonization and symptomatic urinary tract infections can occur with frequent or long-term use. Calcification and erosion also can occur, but “mainly with indwelling inserts, and not with episodic use.”
The reported continence rate with use of the FemSoft urethral insert – the only one currently available in the United States – is 93% at 48 months. Early discontinuation occurs in up to 40% of users, and UTIs occur in about one-third of patients. Still, with this “excellent” continence rate, the urethral insert may have a role for women who wish to postpone or avoid surgery, she said.
Pelvic floor muscle training – the first-line management option for SUI – is often inadequately taught to women, she emphasized. “It can't be effective it's not done correctly, so I'd have that as part of my physical exam … find out, what can she do with her pelvic floor?”
Dr. Lightner reported that she had no disclosures.
Expert Analysis from the Annual Meeting of the American Urological Association
WOCA, Botulinum Toxin Considered for Neurogenic Bladder
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with “neurogenic bladder” and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the meeting.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
“Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive,” said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but “they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity,” Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is “always a point of contention,” several studies have “clearly” shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators “saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) … and most importantly, they did not see any change in the number of multidrug-resistant infections.”
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach “has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months … presumably because the neurogenic bladder management is that much better.”
The term “neurogenic bladder,” Dr. Kraus noted, is one that's “not very precise.” For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with “neurogenic bladder” and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the meeting.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
“Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive,” said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but “they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity,” Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is “always a point of contention,” several studies have “clearly” shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators “saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) … and most importantly, they did not see any change in the number of multidrug-resistant infections.”
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach “has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months … presumably because the neurogenic bladder management is that much better.”
The term “neurogenic bladder,” Dr. Kraus noted, is one that's “not very precise.” For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with “neurogenic bladder” and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the meeting.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
“Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive,” said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but “they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity,” Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is “always a point of contention,” several studies have “clearly” shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators “saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) … and most importantly, they did not see any change in the number of multidrug-resistant infections.”
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach “has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months … presumably because the neurogenic bladder management is that much better.”
The term “neurogenic bladder,” Dr. Kraus noted, is one that's “not very precise.” For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
Expert Analysis from the Annual Meeting of the American Urological Association
Rapid UTI Tests to Permit Point-of-Care Decisions : Personalized selection of agents may help fight antibiotic resistance.
WASHINGTON – Rapid molecular diagnosis of urinary tract infection will soon enable individualized, evidence-based selection of antibiotics “right at the point of care,” according to Dr. Joseph C. Liao.
“Currently we rely on urine culture, which takes 2–3 days at a central microbiology laboratory,” he said. “What if in the future [you] could obtain molecular diagnosis in less than 1 hour right there in your office? And what if we could tailor the choice of antibiotics for the patient sitting in your office [rather than start broad-spectrum antibiotics empirically]?”
Personalized, evidence-based selection of antibiotics has become an increasingly important goal – for both individual and public health – as the problem of antibiotic resistance has intensified, said Dr. Liao and other speakers at the meeting.
Over the past several years, Dr. Liao and his colleagues in the urology department at Stanford (Calif.) University have used biosensor technology to develop an assay for rapid pathogen identification, as well as a biosensor-based antimicrobial susceptibility test for urinary tract infection (UTI).
“We've been able to achieve pathogen identification within an hour, and antimicrobial susceptibility testing within 3 hours,” Dr. Liao reported.
The biosensor (a molecular sensing device that generates a measurable signal in the presence of a target analyte) is already part of everyday clinical practice, he noted. The glucose sensor and the i-STAT portable clinical analyzer, for example, are commonly used biosensor-based devices.
The biosensor being utilized in the “next generation” of UTI diagnostic tools is composed of a chip about the size of a microscope slide with 16 individual sensors. “Like computer technology, it can be mass produced at a relatively low cost,” said Dr. Liao, who is also chief urologist at the Veterans Affairs Palo Alto (Calif.) Health Care System.
The overall strategy for pathogen identification involves lysis of the bacteria present in a urine sample, followed by a hybridization process that enables the sensor to detect bacterial 16S rRNA, a kind of “bacterial molecular fingerprint.” This results in a signal output.
“Essentially, we're converting a molecular hybridization event into an electrical signal,” Dr. Liao explained. “And the higher the bacterial concentration, the higher the signal.”
Bacterial 16S rRNA is also a marker of bacterial growth, a property that Dr. Liao's research group has exploited to develop a biosensor-based antimicrobial susceptibility test (AST).
By incubating a urine sample in the presence or absence of commonly used antibiotics, and quantifying the 16S rRNA level, “we can follow the differential growth and derive the AST,” he said.
Dr. Liao and his colleagues recently completed a clinical validation study in which they compared results from their biosensor platform with results from standard microbiological analysis in more than 200 urine samples collected from patients at the Spinal Cord Injury Service at the Veterans Affairs Palo Alto system.
Pathogen detection sensitivity and specificity were 92% and 97%, respectively, and “in corresponding AST, we found an overall agreement of 94%,” said Dr. Liao, whose study was published early this year (J. Urol. 2011;185:148–53).
In the future, Dr. Liao hopes to use biosensor technology to also detect biomarkers that are shown to be indicative of infection in the presence of pathogens, he said.
Such an integrated assay would detect both biomarkers and pathogens, and thus address the host immunity response as well as identify the pathogen.
This could further improve the now-challenging task of differentiating colonization, simple UTI, and early complicated UTI, “and [could] help us better differentiate and stratify the severity of infection,” he said.
Dr. Liao reported that he had no disclosures.
WASHINGTON – Rapid molecular diagnosis of urinary tract infection will soon enable individualized, evidence-based selection of antibiotics “right at the point of care,” according to Dr. Joseph C. Liao.
“Currently we rely on urine culture, which takes 2–3 days at a central microbiology laboratory,” he said. “What if in the future [you] could obtain molecular diagnosis in less than 1 hour right there in your office? And what if we could tailor the choice of antibiotics for the patient sitting in your office [rather than start broad-spectrum antibiotics empirically]?”
Personalized, evidence-based selection of antibiotics has become an increasingly important goal – for both individual and public health – as the problem of antibiotic resistance has intensified, said Dr. Liao and other speakers at the meeting.
Over the past several years, Dr. Liao and his colleagues in the urology department at Stanford (Calif.) University have used biosensor technology to develop an assay for rapid pathogen identification, as well as a biosensor-based antimicrobial susceptibility test for urinary tract infection (UTI).
“We've been able to achieve pathogen identification within an hour, and antimicrobial susceptibility testing within 3 hours,” Dr. Liao reported.
The biosensor (a molecular sensing device that generates a measurable signal in the presence of a target analyte) is already part of everyday clinical practice, he noted. The glucose sensor and the i-STAT portable clinical analyzer, for example, are commonly used biosensor-based devices.
The biosensor being utilized in the “next generation” of UTI diagnostic tools is composed of a chip about the size of a microscope slide with 16 individual sensors. “Like computer technology, it can be mass produced at a relatively low cost,” said Dr. Liao, who is also chief urologist at the Veterans Affairs Palo Alto (Calif.) Health Care System.
The overall strategy for pathogen identification involves lysis of the bacteria present in a urine sample, followed by a hybridization process that enables the sensor to detect bacterial 16S rRNA, a kind of “bacterial molecular fingerprint.” This results in a signal output.
“Essentially, we're converting a molecular hybridization event into an electrical signal,” Dr. Liao explained. “And the higher the bacterial concentration, the higher the signal.”
Bacterial 16S rRNA is also a marker of bacterial growth, a property that Dr. Liao's research group has exploited to develop a biosensor-based antimicrobial susceptibility test (AST).
By incubating a urine sample in the presence or absence of commonly used antibiotics, and quantifying the 16S rRNA level, “we can follow the differential growth and derive the AST,” he said.
Dr. Liao and his colleagues recently completed a clinical validation study in which they compared results from their biosensor platform with results from standard microbiological analysis in more than 200 urine samples collected from patients at the Spinal Cord Injury Service at the Veterans Affairs Palo Alto system.
Pathogen detection sensitivity and specificity were 92% and 97%, respectively, and “in corresponding AST, we found an overall agreement of 94%,” said Dr. Liao, whose study was published early this year (J. Urol. 2011;185:148–53).
In the future, Dr. Liao hopes to use biosensor technology to also detect biomarkers that are shown to be indicative of infection in the presence of pathogens, he said.
Such an integrated assay would detect both biomarkers and pathogens, and thus address the host immunity response as well as identify the pathogen.
This could further improve the now-challenging task of differentiating colonization, simple UTI, and early complicated UTI, “and [could] help us better differentiate and stratify the severity of infection,” he said.
Dr. Liao reported that he had no disclosures.
WASHINGTON – Rapid molecular diagnosis of urinary tract infection will soon enable individualized, evidence-based selection of antibiotics “right at the point of care,” according to Dr. Joseph C. Liao.
“Currently we rely on urine culture, which takes 2–3 days at a central microbiology laboratory,” he said. “What if in the future [you] could obtain molecular diagnosis in less than 1 hour right there in your office? And what if we could tailor the choice of antibiotics for the patient sitting in your office [rather than start broad-spectrum antibiotics empirically]?”
Personalized, evidence-based selection of antibiotics has become an increasingly important goal – for both individual and public health – as the problem of antibiotic resistance has intensified, said Dr. Liao and other speakers at the meeting.
Over the past several years, Dr. Liao and his colleagues in the urology department at Stanford (Calif.) University have used biosensor technology to develop an assay for rapid pathogen identification, as well as a biosensor-based antimicrobial susceptibility test for urinary tract infection (UTI).
“We've been able to achieve pathogen identification within an hour, and antimicrobial susceptibility testing within 3 hours,” Dr. Liao reported.
The biosensor (a molecular sensing device that generates a measurable signal in the presence of a target analyte) is already part of everyday clinical practice, he noted. The glucose sensor and the i-STAT portable clinical analyzer, for example, are commonly used biosensor-based devices.
The biosensor being utilized in the “next generation” of UTI diagnostic tools is composed of a chip about the size of a microscope slide with 16 individual sensors. “Like computer technology, it can be mass produced at a relatively low cost,” said Dr. Liao, who is also chief urologist at the Veterans Affairs Palo Alto (Calif.) Health Care System.
The overall strategy for pathogen identification involves lysis of the bacteria present in a urine sample, followed by a hybridization process that enables the sensor to detect bacterial 16S rRNA, a kind of “bacterial molecular fingerprint.” This results in a signal output.
“Essentially, we're converting a molecular hybridization event into an electrical signal,” Dr. Liao explained. “And the higher the bacterial concentration, the higher the signal.”
Bacterial 16S rRNA is also a marker of bacterial growth, a property that Dr. Liao's research group has exploited to develop a biosensor-based antimicrobial susceptibility test (AST).
By incubating a urine sample in the presence or absence of commonly used antibiotics, and quantifying the 16S rRNA level, “we can follow the differential growth and derive the AST,” he said.
Dr. Liao and his colleagues recently completed a clinical validation study in which they compared results from their biosensor platform with results from standard microbiological analysis in more than 200 urine samples collected from patients at the Spinal Cord Injury Service at the Veterans Affairs Palo Alto system.
Pathogen detection sensitivity and specificity were 92% and 97%, respectively, and “in corresponding AST, we found an overall agreement of 94%,” said Dr. Liao, whose study was published early this year (J. Urol. 2011;185:148–53).
In the future, Dr. Liao hopes to use biosensor technology to also detect biomarkers that are shown to be indicative of infection in the presence of pathogens, he said.
Such an integrated assay would detect both biomarkers and pathogens, and thus address the host immunity response as well as identify the pathogen.
This could further improve the now-challenging task of differentiating colonization, simple UTI, and early complicated UTI, “and [could] help us better differentiate and stratify the severity of infection,” he said.
Dr. Liao reported that he had no disclosures.
Expert Analysis from the Annual Meeting of the American Urolgical Association
Simplify Headache Therapy to Boost Adherence
WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D.
“The more comprehensive the approach, the more adherence can be improved,” she said at the meeting.
The typical response to treatment failures is changing the drug choice or dosing; that's a mistake, she said. It would be better to assess adherence. “All patients are candidates for adherence facilitation.”
Dr. Rains suggested the following strategies for boosting adherence to headache therapy:
▸ Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. “Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens],” she said.
▸ Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.
▸ Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side effects. Differentiating current treatment from past failures is key, Dr. Rains said.
▸ Predict a positive but realistic outcome.
▸ Associate any positive outcome to patient behavior and perseverance.
There is no sure way to assess and track adherence accurately, she acknowledged.
Face-to-face interviewing is the most widely used tool, but it also is the least reliable. “Self-reporting actually overestimates adherence by 30%, compared with more objective monitoring,” she said. Diaries and questionnaires are better, and electronic measures are better still. “Yet, even the most objective measures are not entirely reliable,” she said. “Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of the office visit.”
Mechanical and electronic tools can “remind” patients to take a preset dose and track their use, but these tools do not address a patient's conscious decision to alter a regimen, she warned.
Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that “nonadherence with headache medication regimens is common,” said Dr. Rains, who reviewed the literature on headache treatment compliance and empiric adherence-enhancing strategies.
“And patients who don't take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache,” said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital in Manchester, N.H.
One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.
Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to “wait to see if it's a migraine or if it's severe,” she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.
This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others.
“And remember, repetition increases retention,” she said.
Moreover, “the way we engage is important,” Dr. Rains said. Adherence increases “not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they're doing well.”
She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. “At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you've been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan.” Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients' motivation for treatment often shifts over time.
Dr. Rains reported that she had no relevant financial disclosures.
'Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens].'
Source DR. RAINS
WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D.
“The more comprehensive the approach, the more adherence can be improved,” she said at the meeting.
The typical response to treatment failures is changing the drug choice or dosing; that's a mistake, she said. It would be better to assess adherence. “All patients are candidates for adherence facilitation.”
Dr. Rains suggested the following strategies for boosting adherence to headache therapy:
▸ Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. “Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens],” she said.
▸ Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.
▸ Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side effects. Differentiating current treatment from past failures is key, Dr. Rains said.
▸ Predict a positive but realistic outcome.
▸ Associate any positive outcome to patient behavior and perseverance.
There is no sure way to assess and track adherence accurately, she acknowledged.
Face-to-face interviewing is the most widely used tool, but it also is the least reliable. “Self-reporting actually overestimates adherence by 30%, compared with more objective monitoring,” she said. Diaries and questionnaires are better, and electronic measures are better still. “Yet, even the most objective measures are not entirely reliable,” she said. “Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of the office visit.”
Mechanical and electronic tools can “remind” patients to take a preset dose and track their use, but these tools do not address a patient's conscious decision to alter a regimen, she warned.
Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that “nonadherence with headache medication regimens is common,” said Dr. Rains, who reviewed the literature on headache treatment compliance and empiric adherence-enhancing strategies.
“And patients who don't take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache,” said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital in Manchester, N.H.
One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.
Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to “wait to see if it's a migraine or if it's severe,” she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.
This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others.
“And remember, repetition increases retention,” she said.
Moreover, “the way we engage is important,” Dr. Rains said. Adherence increases “not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they're doing well.”
She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. “At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you've been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan.” Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients' motivation for treatment often shifts over time.
Dr. Rains reported that she had no relevant financial disclosures.
'Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens].'
Source DR. RAINS
WASHINGTON – Strategies to increase adherence to headache therapy work best when multiple modalities are used together at every visit throughout the duration of treatment, according to Jeanetta C. Rains, Ph.D.
“The more comprehensive the approach, the more adherence can be improved,” she said at the meeting.
The typical response to treatment failures is changing the drug choice or dosing; that's a mistake, she said. It would be better to assess adherence. “All patients are candidates for adherence facilitation.”
Dr. Rains suggested the following strategies for boosting adherence to headache therapy:
▸ Assess and treat comorbidities and behavioral concerns. Unaddressed depression, anxiety, somatic preoccupation, and low self-efficacy can each affect adherence and subsequent outcomes. “Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens],” she said.
▸ Simplify the treatment regimen. Studies consistently show that adherence decreases as the number of medications and daily doses increase.
▸ Consider past behavior and prior experience. Positive prior experiences with medication can enhance response, while negative expectancies may worsen symptoms and amplify side effects. Differentiating current treatment from past failures is key, Dr. Rains said.
▸ Predict a positive but realistic outcome.
▸ Associate any positive outcome to patient behavior and perseverance.
There is no sure way to assess and track adherence accurately, she acknowledged.
Face-to-face interviewing is the most widely used tool, but it also is the least reliable. “Self-reporting actually overestimates adherence by 30%, compared with more objective monitoring,” she said. Diaries and questionnaires are better, and electronic measures are better still. “Yet, even the most objective measures are not entirely reliable,” she said. “Studies have shown, for instance, that some patients dump their canisters in anticipation of their visits, and that electronic daily diaries are sometimes completed on the day of the office visit.”
Mechanical and electronic tools can “remind” patients to take a preset dose and track their use, but these tools do not address a patient's conscious decision to alter a regimen, she warned.
Relatively few studies have addressed the issue of adherence in headache treatment, but the literature definitively shows that “nonadherence with headache medication regimens is common,” said Dr. Rains, who reviewed the literature on headache treatment compliance and empiric adherence-enhancing strategies.
“And patients who don't take their medication or who overuse symptomatic medications can aggravate their headache, create a pattern of medication-overuse headache, or transform an episodic headache into a chronic daily headache,” said Dr. Rains, who directs the center for sleep evaluation at Elliot Hospital in Manchester, N.H.
One large study of patients with severe headache found that 11% did not fill their initial prescriptions (high cost and concerns about side effects were common reasons) and that 70% did not adhere to their abortive medication regimen.
Other studies have shown that 25%-50% of headache patients do not adhere to their preventive medication regimen, and commonly avoid or delay the use of abortive medication because they want to “wait to see if it's a migraine or if it's severe,” she said. Concerns about adverse effects and dependency or addiction also are cited as factors in avoiding or delaying use of abortive medications.
This makes education critical. For effective patient education about headache and forms of treatment, physicians should use simple, everyday language; limit instructions to three or four major points; supplement verbal with printed instructions; ask patients to restate the plan; and involve family members or significant others.
“And remember, repetition increases retention,” she said.
Moreover, “the way we engage is important,” Dr. Rains said. Adherence increases “not only when we give more information to patients, but also when we ask patients about their feelings and opinions, and when we praise them when they're doing well.”
She advised forming a collaborative alliance, discussing barriers to treatment, and being supportive of patients who have difficulty meeting their goals. “At the end of a visit, you can ask your patient to rate how important it is for him or her to do the things you've been talking about. Then you can ask the patient to rate his or her confidence level for adhering to the treatment plan.” Behavioral strategies can help to target the many psychosocial determinants of adherence, as well as the fact that patients' motivation for treatment often shifts over time.
Dr. Rains reported that she had no relevant financial disclosures.
'Patients who are depressed, for instance, are three times less likely to take [their prescribed regimens].'
Source DR. RAINS
Patients Want Detailed After-Visit Summaries
WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.
“Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more,” said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research “actually align very well with components of the meaningful use requirements.”
The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.
“As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention,” Dr. Nash said at the meeting. But “we really don't know, though, what the optimal content and format of the [summary] might be.”
The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.
The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.
Physicians reported using the summaries in a number of ways. “Some routinely print and review the [summary] with their patients, essentially every time,” Dr. Nash said. “Others rarely even see or discuss it with their patients because these tasks are handled by someone else.”
The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.
Most physicians “reported a lot of confusion on the part of their patients,” said Dr. Nash, an instructor of family and community medicine at Baylor.
Mismatches between language and reading level also concerned physicians, as did privacy. “Some [physicians] were very concerned about showing potentially sensitive information on the patients' records if it would automatically appear on the summary,” Dr. Nash said.
Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.
Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.
The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.
Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.
Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.
Dr. Nash reported that she had no disclosures to make.
WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.
“Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more,” said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research “actually align very well with components of the meaningful use requirements.”
The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.
“As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention,” Dr. Nash said at the meeting. But “we really don't know, though, what the optimal content and format of the [summary] might be.”
The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.
The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.
Physicians reported using the summaries in a number of ways. “Some routinely print and review the [summary] with their patients, essentially every time,” Dr. Nash said. “Others rarely even see or discuss it with their patients because these tasks are handled by someone else.”
The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.
Most physicians “reported a lot of confusion on the part of their patients,” said Dr. Nash, an instructor of family and community medicine at Baylor.
Mismatches between language and reading level also concerned physicians, as did privacy. “Some [physicians] were very concerned about showing potentially sensitive information on the patients' records if it would automatically appear on the summary,” Dr. Nash said.
Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.
Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.
The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.
Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.
Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.
Dr. Nash reported that she had no disclosures to make.
WASHINGTON – Patients want more information about their medical visits than physicians think they need or can benefit from, according to a study of physician and patient perspectives on the after-visit summary generated by electronic health record systems.
“Doctors think patients should get one or two pages of information, no more, or it will be too much. Patients, on the other hand, were asking for more,” said Susan Nash, Ph.D., of Baylor College of Medicine, Houston, who added that the content areas requested by patients in their research “actually align very well with components of the meaningful use requirements.”
The content of the after-visit summary is currently being standardized as one of the 15 core requirements of meaningful use that is necessary for physicians and other providers to receive federal EHR incentive payments. All certified EHR systems will need to be capable of providing the patient with a summary of the topics and instructions that were discussed during each medical visit.
“As much as 40%-80% of information that patients get within an office visit is forgotten by the time they leave the clinic. Written information that supports the verbal information can be helpful for improving patient understanding and retention,” Dr. Nash said at the meeting. But “we really don't know, though, what the optimal content and format of the [summary] might be.”
The investigators conducted individual interviews with 12 family physicians and 48 of their adult patients regarding their experiences, attitudes, preferences, and recommendations for the content and format of the after-visit summary.
The physicians and patients were recruited from two private and two public primary care clinics serving diverse socioeconomic populations. All clinics were affiliated with Baylor College of Medicine, and all used EHRs that offer some type of electronically generated after-visit summary.
Physicians reported using the summaries in a number of ways. “Some routinely print and review the [summary] with their patients, essentially every time,” Dr. Nash said. “Others rarely even see or discuss it with their patients because these tasks are handled by someone else.”
The physicians almost uniformly view the after-visit summary as a potentially useful tool for patient education and continuity of care, but they also felt that it falls short in a number of ways, most notably with respect to its medication and problem lists, which some said mix the old and new, and the active and inactive.
Most physicians “reported a lot of confusion on the part of their patients,” said Dr. Nash, an instructor of family and community medicine at Baylor.
Mismatches between language and reading level also concerned physicians, as did privacy. “Some [physicians] were very concerned about showing potentially sensitive information on the patients' records if it would automatically appear on the summary,” Dr. Nash said.
Patients overall reported a high level of satisfaction with the after-visit summaries they received, but wanted even more information, Dr. Nash reported.
Patients wanted simplified medical terminology, but more explanation of diagnoses and medications, more specific health goals, and educational features such as personalized diet and exercise plans.
The desire for more detail on medications – as well as clearer lists that focus on newly prescribed medications – was a major theme.
Like physicians, patients also brought up issues of privacy, reading level, and language. Of the 48 patients, 18 were Spanish speakers but received the summary in English.
Based on their findings, the Baylor investigators have developed several experimental models of the after-visit summary and are testing them on patient satisfaction, recall, and use of health information, as well as adherence to treatment recommendations.
Dr. Nash reported that she had no disclosures to make.
Injections for Stress Incontinence an Option When Surgery Isn't
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE AMERICAN UROLOGICAL ASSOCIATION
Injections for Stress Incontinence an Option When Surgery Isn't
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
WASHINGTON – Urethral bulking with injectable therapy is an option to consider for the treatment of stress incontinence in elderly women who aren’t candidates for a sling procedure, according to Dr. Richard D. Cespedes.
It’s a good option for, say, the 83-year-old woman with no prior urologic history, stage 1 prolapse and urethral hypermobility, and comorbidities requiring anticoagulant therapy, said Dr. Cespedes of the comprehensive continence and pelvic health center at the Shore Health System in Easton, Md.
"The elderly generally have a greater risk of retention with a sling procedure," he said. "And I never have to have my patients come off their [anticoagulant] medications for injection therapy. ... I’ve never had any significant bleeding."
Patients are more satisfied with injectable therapy when they appreciate that lasting continence can be achieved through multiple injections spaced about a month apart, with periodic reinjections after that.
"Think of it as a process for tissue expansion ... [that’s] best performed slowly," with only one to two syringes injected per visit and 4-6 weeks between visits to allow for tissue incorporation or encapsulation, Dr. Cespedes said. "Injections may be repeated for essentially any length of time with continued good results in most cases. I’ve injected patients once a year for 10 years with no loss in efficacy."
Bovine collagen (Contigen) is no longer available, he said, but the three newer injectables that are currently available – calcium hydroxylapatite particles (Coaptite), polydimethylsiloxane (Macroplastique), and carbon-coated beads (Durasphere EXP) – all have better durability than collagen, he said during a discussion of office-based therapy for stress urinary incontinence at the annual meeting of the American Urological Association.
The bulking agents are injected in the submucosa of the bladder neck or the midurethra.
Elderly females who aren’t good candidates for open procedures and who have significant incontinence symptoms are "by far ... the largest group I inject," he said, but young women who aren’t candidates for a sling procedure may also benefit from the injectables.
Dr. Saad Juma of the Incontinence Research Institute in Encinitas, Calif., said that the 83-year-old patient would also be a candidate for radiotherapy of the bladder neck and proximal urethra using controlled, low-level radiofrequency energy. The therapy, known as transurethral radiofrequency collagen remodeling, is a Food and Drug Administration–approved, office-based, minimally invasive procedure for management of female stress urinary incontinence due to bladder neck hypermobility.
The therapy results in microscopic collagen denaturation and subsequent reduced tissue compliance. "Urethral resistance increases ... and mucosa and deeper urethral tissues are preserved," he explained.
Dr. Cespedes reported having no relevant financial disclosures, and Dr. Juma reported that he is a consultant/adviser to American Medical Systems, Coloplast, and Contura, as well as an investigator with Bioform, Contura, and Solace Therapeutics.
EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE AMERICAN UROLOGICAL ASSOCIATION
Managing Recurrent UTIs in the Patient With Neurogenic Bladder
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with "neurogenic bladder" and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the annual meeting of the American Urological Association.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
"Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive," said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but "they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity," Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is "always a point of contention," several studies have "clearly" shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators "saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) ... and most importantly, they did not see any change in the number of multidrug-resistant infections," he said.
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach "has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months ... presumably because the neurogenic bladder management is that much better," he said.
The term "neurogenic bladder," Dr. Kraus noted, is one that’s "not very precise." For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with "neurogenic bladder" and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the annual meeting of the American Urological Association.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
"Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive," said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but "they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity," Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is "always a point of contention," several studies have "clearly" shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators "saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) ... and most importantly, they did not see any change in the number of multidrug-resistant infections," he said.
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach "has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months ... presumably because the neurogenic bladder management is that much better," he said.
The term "neurogenic bladder," Dr. Kraus noted, is one that’s "not very precise." For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
WASHINGTON – How should one manage a 35-year-old woman with multiple sclerosis on self-clean intermittent catheterization who complains of pelvic pain and cloudy urine?
Such a patient with "neurogenic bladder" and possible urinary tract infection needs careful diagnosis, catheterization review, and possibly other management considerations, said Dr. Stephen R. Kraus during a panel discussion of recurrent UTIs at the annual meeting of the American Urological Association.
Patients with neurogenic bladder commonly have chronic bacteriuria and recurrent UTIs, and thus generally require a combination of bacteriuria and leukocyturia – as well as clinical symptoms or an increase in autonomic dysreflexia – for the initiation of empirical UTI therapy. Such criteria will help avoid unnecessary use of antibiotics.
"Original criteria were based on bacterial colonization counts but were criticized for being highly insensitive," said Dr. Kraus, professor and vice chairman of the department of urology at the University of Texas, San Antonio.
Assuming the patient has already had a video urodynamic test, Dr. Kraus said, he would obtain a catheterized specimen for urinalysis, culture, and a sensitivity test; treat as needed; and then consider increasing her catheterization frequency. A trial of a hydrophilic catheter could also be considered in the context of recurrent UTIs, he said.
Various catheter modifications – from silver alloy catheters to antibiotic-impregnated catheters – have been used with some success in reducing the risk of UTIs, but "they carry their own problems such as cost, development of resistance, and even, as one study suggested, the possibility of silver toxicity," Dr. Kraus said.
Two randomized, controlled trials have shown that hydrophilic catheters will reduce the risk of UTIs, compared with regular polyvinyl chloride catheters, he noted. Although the choice of single-use vs. reusable catheters is "always a point of contention," several studies have "clearly" shown that clean intermittent catheterization (CIC) poses no greater risk of recurrent UTIs than do single-use catheters, he added.
Frequent changing of intermittent catheters can prevent biofilm development, and one study showed that UTI was five times less likely when CIC was performed six times per day rather than three times per day, he noted.
Routine chronic antibiotic prophylaxis should be avoided in patients with neurogenic bladder, he said, but a short course of antibiotics could be useful during the initial CIC period, and is certainly prudent before any invasive genitourinary procedures are performed.
Dr. Kraus said he is intrigued by the concept of a weekly oral cyclic antibiotic (WOCA) program that uses weekly alternating antibiotics as a prophylactic measure. In one 2-year trial of WOCA, investigators "saw dramatic reductions in UTIs (from 9.4 to 1.8 per patient year) ... and most importantly, they did not see any change in the number of multidrug-resistant infections," he said.
As a final management option for the above-described patient, Dr. Kraus said he would consider injections of botulinum toxin (Botox). This approach "has exploded in the market for neurogenic bladder management, and it has been associated with a significant reduction in UTI at 6 months ... presumably because the neurogenic bladder management is that much better," he said.
The term "neurogenic bladder," Dr. Kraus noted, is one that’s "not very precise." For the purposes of his discussion, he defined it as a condition in which the bladder is affected by a neurologic process and has an impaired ability to store and empty urine.
Dr. Kraus disclosed that he is an investigator for the National Institute of Diabetes and Digestive and Kidney Diseases, a course director for Laborie (which manufactures catheters and other products for urinary and pelvic disorders), and a consultant/adviser for Pfizer.
EXPERT ANALYSIS FROM THE ANNUAL MEETING OF THE AMERICAN UROLOGICAL ASSOCIATION