Sharon Worcester

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections—visible because of the methylene blue wheals that form at the injection sites—are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said.

She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said.

However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections—visible because of the methylene blue wheals that form at the injection sites—are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said.

She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said.

However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections—visible because of the methylene blue wheals that form at the injection sites—are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said.

She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said.

However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.

ATLANTA — Cystoscopy with intravenous indigo carmine dye is safe and accurate for detecting ureteral obstruction following vaginal surgery for pelvic organ prolapse, Arlan M. Gustilo-Ashby, M.D., said at the annual meeting of the American Urogynecologic Society.

Although the technique is commonly used for secondary prevention of ureteral injury in patients undergoing vaginal surgery, its accuracy and efficacy have not been well defined, according to Dr. Gustilo-Ashby of the Cleveland Clinic Foundation.

In a retrospective study of 700 patients who underwent vaginal surgery for anterior and/or apical prolapse from 2001 to 2004, and who also underwent intraoperative cystoscopy with intravenous indigo carmine to evaluate ureteral patency, 37 patients (5.3%) had no spillage of dye from either ureter. Three of the 37 patients had preexisting renal pathology that caused the lack of spillage, and two other patients were later found to have ureteral obstruction.

Thus, the true incidence of ureteral obstruction was 5.1%, according to Dr. Gustilo-Ashby.

The incidence of ureteral obstruction in this study was highest among those patients who underwent uterosacral ligament vaginal vault suspension (5.9%), and lowest among those who underwent distal McCall's culdoplasty (0.5%) or anterior colporrhaphy (0.4%), he noted at the meeting.

In 88% of the cases of ureteral obstruction, suture removal relieved the obstruction, and in 83% of cases, the suture removal was temporary (six patients required subsequent intervention), therefore the use of cystoscopy reduced the true ureteral injury rate in this study to 0.9%, he said.

ATLANTA — Cystoscopy with intravenous indigo carmine dye is safe and accurate for detecting ureteral obstruction following vaginal surgery for pelvic organ prolapse, Arlan M. Gustilo-Ashby, M.D., said at the annual meeting of the American Urogynecologic Society.

Although the technique is commonly used for secondary prevention of ureteral injury in patients undergoing vaginal surgery, its accuracy and efficacy have not been well defined, according to Dr. Gustilo-Ashby of the Cleveland Clinic Foundation.

In a retrospective study of 700 patients who underwent vaginal surgery for anterior and/or apical prolapse from 2001 to 2004, and who also underwent intraoperative cystoscopy with intravenous indigo carmine to evaluate ureteral patency, 37 patients (5.3%) had no spillage of dye from either ureter. Three of the 37 patients had preexisting renal pathology that caused the lack of spillage, and two other patients were later found to have ureteral obstruction.

Thus, the true incidence of ureteral obstruction was 5.1%, according to Dr. Gustilo-Ashby.

The incidence of ureteral obstruction in this study was highest among those patients who underwent uterosacral ligament vaginal vault suspension (5.9%), and lowest among those who underwent distal McCall's culdoplasty (0.5%) or anterior colporrhaphy (0.4%), he noted at the meeting.

In 88% of the cases of ureteral obstruction, suture removal relieved the obstruction, and in 83% of cases, the suture removal was temporary (six patients required subsequent intervention), therefore the use of cystoscopy reduced the true ureteral injury rate in this study to 0.9%, he said.

ATLANTA — Cystoscopy with intravenous indigo carmine dye is safe and accurate for detecting ureteral obstruction following vaginal surgery for pelvic organ prolapse, Arlan M. Gustilo-Ashby, M.D., said at the annual meeting of the American Urogynecologic Society.

Although the technique is commonly used for secondary prevention of ureteral injury in patients undergoing vaginal surgery, its accuracy and efficacy have not been well defined, according to Dr. Gustilo-Ashby of the Cleveland Clinic Foundation.

In a retrospective study of 700 patients who underwent vaginal surgery for anterior and/or apical prolapse from 2001 to 2004, and who also underwent intraoperative cystoscopy with intravenous indigo carmine to evaluate ureteral patency, 37 patients (5.3%) had no spillage of dye from either ureter. Three of the 37 patients had preexisting renal pathology that caused the lack of spillage, and two other patients were later found to have ureteral obstruction.

Thus, the true incidence of ureteral obstruction was 5.1%, according to Dr. Gustilo-Ashby.

The incidence of ureteral obstruction in this study was highest among those patients who underwent uterosacral ligament vaginal vault suspension (5.9%), and lowest among those who underwent distal McCall's culdoplasty (0.5%) or anterior colporrhaphy (0.4%), he noted at the meeting.

In 88% of the cases of ureteral obstruction, suture removal relieved the obstruction, and in 83% of cases, the suture removal was temporary (six patients required subsequent intervention), therefore the use of cystoscopy reduced the true ureteral injury rate in this study to 0.9%, he said.

ATLANTA — Preemptive pudendal nerve blockade had no effect on postoperative pain or use of narcotic analgesia in a prospective randomized study of patients undergoing pelvic reconstructive surgery.

A total of 102 patients undergoing transvaginal pelvic reconstruction under general anesthesia induced by intravenous fentanyl and propofol were randomized in double-blind fashion to receive pudendal block with either bupivacaine 0.25% or normal saline as placebo just before surgery. Patient-reported pain intensity at six time points in the 24 hours after surgery was similar in both groups, as was consumption of patient-controlled hydromorphone at three time points after surgery, Yoram Abramov, M.D., reported at the annual meeting of the American Urogynecologic Society.

Although some clinical studies have suggested that preemptive analgesia may reduce postoperative pain and consumption of postoperative narcotics, no prior studies have evaluated its effects in patients undergoing vaginal surgery, said Dr. Abramov of Northwestern University, Chicago.

Although it is possible that the threshold for the type of pain experienced by women undergoing vaginal surgery was too low to elicit a statistically significant difference in this study, it may be that the preemptive approach simply does not work in this population, he said.

Mean postoperative pain scores in the treatment vs. placebo groups—as measured using a validated visual analog scale of 0–10 points—were 4.63 and 4.80 at 1 hour, 3.71 and 3.87 at 3 hours, 2.89 and 3.10 at 5 hours, 2.85 and 3.12 at 7 hours, 3.22 and 3.47 at 18 hours, and 3.23 and 3.12 at 24 hours. Consumption of patient-controlled hydromorphone in the treatment vs. placebo groups was 1.84 mg and 1.77 mg at 0–3 hours, 1.19 mg and 1.20 mg at 4–7 hours, and 2.89 mg and 2.35 mg at 8–18 hours.

The treatment and placebo groups were similar with regard to the percentage of patients requiring additional boluses of hydromorphone (18% in each group) or ketorolac (8% and 12%), and with regard to 24-hour mean oral hydrocodone consumption (10.6 mg and 12.7 mg) and mean ibuprofen consumption (630 mg and 762 mg).

There were no complications associated with the pudendal nerve block.

ATLANTA — Preemptive pudendal nerve blockade had no effect on postoperative pain or use of narcotic analgesia in a prospective randomized study of patients undergoing pelvic reconstructive surgery.

A total of 102 patients undergoing transvaginal pelvic reconstruction under general anesthesia induced by intravenous fentanyl and propofol were randomized in double-blind fashion to receive pudendal block with either bupivacaine 0.25% or normal saline as placebo just before surgery. Patient-reported pain intensity at six time points in the 24 hours after surgery was similar in both groups, as was consumption of patient-controlled hydromorphone at three time points after surgery, Yoram Abramov, M.D., reported at the annual meeting of the American Urogynecologic Society.

Although some clinical studies have suggested that preemptive analgesia may reduce postoperative pain and consumption of postoperative narcotics, no prior studies have evaluated its effects in patients undergoing vaginal surgery, said Dr. Abramov of Northwestern University, Chicago.

Although it is possible that the threshold for the type of pain experienced by women undergoing vaginal surgery was too low to elicit a statistically significant difference in this study, it may be that the preemptive approach simply does not work in this population, he said.

Mean postoperative pain scores in the treatment vs. placebo groups—as measured using a validated visual analog scale of 0–10 points—were 4.63 and 4.80 at 1 hour, 3.71 and 3.87 at 3 hours, 2.89 and 3.10 at 5 hours, 2.85 and 3.12 at 7 hours, 3.22 and 3.47 at 18 hours, and 3.23 and 3.12 at 24 hours. Consumption of patient-controlled hydromorphone in the treatment vs. placebo groups was 1.84 mg and 1.77 mg at 0–3 hours, 1.19 mg and 1.20 mg at 4–7 hours, and 2.89 mg and 2.35 mg at 8–18 hours.

The treatment and placebo groups were similar with regard to the percentage of patients requiring additional boluses of hydromorphone (18% in each group) or ketorolac (8% and 12%), and with regard to 24-hour mean oral hydrocodone consumption (10.6 mg and 12.7 mg) and mean ibuprofen consumption (630 mg and 762 mg).

There were no complications associated with the pudendal nerve block.

ATLANTA — Preemptive pudendal nerve blockade had no effect on postoperative pain or use of narcotic analgesia in a prospective randomized study of patients undergoing pelvic reconstructive surgery.

A total of 102 patients undergoing transvaginal pelvic reconstruction under general anesthesia induced by intravenous fentanyl and propofol were randomized in double-blind fashion to receive pudendal block with either bupivacaine 0.25% or normal saline as placebo just before surgery. Patient-reported pain intensity at six time points in the 24 hours after surgery was similar in both groups, as was consumption of patient-controlled hydromorphone at three time points after surgery, Yoram Abramov, M.D., reported at the annual meeting of the American Urogynecologic Society.

Although some clinical studies have suggested that preemptive analgesia may reduce postoperative pain and consumption of postoperative narcotics, no prior studies have evaluated its effects in patients undergoing vaginal surgery, said Dr. Abramov of Northwestern University, Chicago.

Although it is possible that the threshold for the type of pain experienced by women undergoing vaginal surgery was too low to elicit a statistically significant difference in this study, it may be that the preemptive approach simply does not work in this population, he said.

Mean postoperative pain scores in the treatment vs. placebo groups—as measured using a validated visual analog scale of 0–10 points—were 4.63 and 4.80 at 1 hour, 3.71 and 3.87 at 3 hours, 2.89 and 3.10 at 5 hours, 2.85 and 3.12 at 7 hours, 3.22 and 3.47 at 18 hours, and 3.23 and 3.12 at 24 hours. Consumption of patient-controlled hydromorphone in the treatment vs. placebo groups was 1.84 mg and 1.77 mg at 0–3 hours, 1.19 mg and 1.20 mg at 4–7 hours, and 2.89 mg and 2.35 mg at 8–18 hours.

The treatment and placebo groups were similar with regard to the percentage of patients requiring additional boluses of hydromorphone (18% in each group) or ketorolac (8% and 12%), and with regard to 24-hour mean oral hydrocodone consumption (10.6 mg and 12.7 mg) and mean ibuprofen consumption (630 mg and 762 mg).

There were no complications associated with the pudendal nerve block.

ATLANTA — Uterosacral ligament vault suspension for the repair of enterocele and vaginal vault prolapse is a durable procedure, 5-year outcomes data suggest.

Of 110 patients who underwent the procedure for advanced pelvic organ prolapse, 72 returned for follow-up assessment at a mean of 5.1 years. Vaginal hysterectomy was performed in 37% of the patients, anterior colporrhaphy was performed in 58%, posterior colporrhaphy was performed in 87%, and a urethral sling was performed in 34%.

Surgical failure, defined as recurrent symptomatic prolapse of stage II or greater in at least one segment, occurred in 15%, and only two patients had further surgery for prolapse, William A.Z. Silva, M.D., reported at the annual meeting of the American Urogynecologic Society.

Furthermore, most patients had improvement or maintenance of pelvic floor function. Overall, postoperative Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI) scores were significantly improved, compared with preoperative scores, as were scores in the irritative, obstructive, and stress domains of these instruments.

The rate of bowel dysfunction did not differ significantly in the pre- and postoperative periods, with 33% reporting preoperative dysfunction, and 27% reporting postoperative dysfunction, said Dr. Silva, formerly of Good Samaritan Hospital, Cincinnati, and currently with St. Francis Hospital, Federal Way, Wash.

Mean postoperative Female Sexual Function Index (FSFI) scores for arousal, lubrication, orgasm, satisfaction, and pain were all in the normal range. About 54% were sexually active postoperatively, compared with 66% in the preoperative period, but 94% at follow-up reportedly were satisfied with their sex lives.

ATLANTA — Uterosacral ligament vault suspension for the repair of enterocele and vaginal vault prolapse is a durable procedure, 5-year outcomes data suggest.

Of 110 patients who underwent the procedure for advanced pelvic organ prolapse, 72 returned for follow-up assessment at a mean of 5.1 years. Vaginal hysterectomy was performed in 37% of the patients, anterior colporrhaphy was performed in 58%, posterior colporrhaphy was performed in 87%, and a urethral sling was performed in 34%.

Surgical failure, defined as recurrent symptomatic prolapse of stage II or greater in at least one segment, occurred in 15%, and only two patients had further surgery for prolapse, William A.Z. Silva, M.D., reported at the annual meeting of the American Urogynecologic Society.

Furthermore, most patients had improvement or maintenance of pelvic floor function. Overall, postoperative Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI) scores were significantly improved, compared with preoperative scores, as were scores in the irritative, obstructive, and stress domains of these instruments.

The rate of bowel dysfunction did not differ significantly in the pre- and postoperative periods, with 33% reporting preoperative dysfunction, and 27% reporting postoperative dysfunction, said Dr. Silva, formerly of Good Samaritan Hospital, Cincinnati, and currently with St. Francis Hospital, Federal Way, Wash.

Mean postoperative Female Sexual Function Index (FSFI) scores for arousal, lubrication, orgasm, satisfaction, and pain were all in the normal range. About 54% were sexually active postoperatively, compared with 66% in the preoperative period, but 94% at follow-up reportedly were satisfied with their sex lives.

ATLANTA — Uterosacral ligament vault suspension for the repair of enterocele and vaginal vault prolapse is a durable procedure, 5-year outcomes data suggest.

Of 110 patients who underwent the procedure for advanced pelvic organ prolapse, 72 returned for follow-up assessment at a mean of 5.1 years. Vaginal hysterectomy was performed in 37% of the patients, anterior colporrhaphy was performed in 58%, posterior colporrhaphy was performed in 87%, and a urethral sling was performed in 34%.

Surgical failure, defined as recurrent symptomatic prolapse of stage II or greater in at least one segment, occurred in 15%, and only two patients had further surgery for prolapse, William A.Z. Silva, M.D., reported at the annual meeting of the American Urogynecologic Society.

Furthermore, most patients had improvement or maintenance of pelvic floor function. Overall, postoperative Incontinence Impact Questionnaire (IIQ) and Urogenital Distress Inventory (UDI) scores were significantly improved, compared with preoperative scores, as were scores in the irritative, obstructive, and stress domains of these instruments.

The rate of bowel dysfunction did not differ significantly in the pre- and postoperative periods, with 33% reporting preoperative dysfunction, and 27% reporting postoperative dysfunction, said Dr. Silva, formerly of Good Samaritan Hospital, Cincinnati, and currently with St. Francis Hospital, Federal Way, Wash.

Mean postoperative Female Sexual Function Index (FSFI) scores for arousal, lubrication, orgasm, satisfaction, and pain were all in the normal range. About 54% were sexually active postoperatively, compared with 66% in the preoperative period, but 94% at follow-up reportedly were satisfied with their sex lives.

CHARLESTON, S.C. — Rapid real-time polymerase chain reaction testing for group B streptococcus detection proved at least as sensitive and specific as standard culture screening at 35–37 weeks' gestation in a recent study.

Two vaginal-rectal swabs were collected from each of 190 women enrolled in the study after presenting in labor. One sample was tested using the Food and Drug Administration-approved IDI-Strep B assay and analyzed using the FDA-approved Smart Cycler I instrument; the other sample was used for enriched culture for GBS, Deborah M. Money, M.D., reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

In the more than 150 women in the study who also underwent the currently recommended 35- to 37-week culture screening and had results available for analysis, the rapid test had a sensitivity of 89%, compared with 85% for the 35- to 37-week culture, and a positive predictive value of 97%, compared with 94% for the 35- to 37-week culture. The values were based on comparison with culture at delivery, said Dr. Money of the University of British Columbia, Vancouver.

The median time from specimen acquisition to availability of results with the rapid test was 90 minutes, with a range of 30 minutes to 4 hours. About 87% of results were available within 2 hours; cultures can require a few days for results. Colonization rates were about 30% with both the rapid test and the culture, she said.

Theoretically, the rapid test could be used during labor to circumvent some of the potential problems inherent in the 35− to 37-week culture method of screening, such as its reliance on the provider to do the screening properly, the uncertainty of the availability of results by delivery (which can jeopardize the chance of a colonized patient receiving the recommended 4 hours of antibiotic therapy during labor for preventing vertical transmission), and the fact that some women do not have prenatal care and would therefore not present for the 35− to 37-week culture. But with the similar sensitivity and specificity to 35− to 37-week culture demonstrated by the rapid test in this study, its usefulness for routine care is unclear.

“We were a little surprised by the lack of superiority of PCR to the culture methodology,” said Dr. Money, adding that larger studies will be required to determine if there is a statistically significant sensitivity and cost advantage with the rapid test over the 35− to 37-week culture.

One setting in which the rapid test can be of particular use now, however, is in patients who present in labor without information regarding their group B strep status. For those patients, the test is feasible, it has a reasonable turnaround time and a comparable result to culture screening, and it can be performed in a busy labor and delivery room, she said.

CHARLESTON, S.C. — Rapid real-time polymerase chain reaction testing for group B streptococcus detection proved at least as sensitive and specific as standard culture screening at 35–37 weeks' gestation in a recent study.

Two vaginal-rectal swabs were collected from each of 190 women enrolled in the study after presenting in labor. One sample was tested using the Food and Drug Administration-approved IDI-Strep B assay and analyzed using the FDA-approved Smart Cycler I instrument; the other sample was used for enriched culture for GBS, Deborah M. Money, M.D., reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

In the more than 150 women in the study who also underwent the currently recommended 35- to 37-week culture screening and had results available for analysis, the rapid test had a sensitivity of 89%, compared with 85% for the 35- to 37-week culture, and a positive predictive value of 97%, compared with 94% for the 35- to 37-week culture. The values were based on comparison with culture at delivery, said Dr. Money of the University of British Columbia, Vancouver.

The median time from specimen acquisition to availability of results with the rapid test was 90 minutes, with a range of 30 minutes to 4 hours. About 87% of results were available within 2 hours; cultures can require a few days for results. Colonization rates were about 30% with both the rapid test and the culture, she said.

Theoretically, the rapid test could be used during labor to circumvent some of the potential problems inherent in the 35− to 37-week culture method of screening, such as its reliance on the provider to do the screening properly, the uncertainty of the availability of results by delivery (which can jeopardize the chance of a colonized patient receiving the recommended 4 hours of antibiotic therapy during labor for preventing vertical transmission), and the fact that some women do not have prenatal care and would therefore not present for the 35− to 37-week culture. But with the similar sensitivity and specificity to 35− to 37-week culture demonstrated by the rapid test in this study, its usefulness for routine care is unclear.

“We were a little surprised by the lack of superiority of PCR to the culture methodology,” said Dr. Money, adding that larger studies will be required to determine if there is a statistically significant sensitivity and cost advantage with the rapid test over the 35− to 37-week culture.

One setting in which the rapid test can be of particular use now, however, is in patients who present in labor without information regarding their group B strep status. For those patients, the test is feasible, it has a reasonable turnaround time and a comparable result to culture screening, and it can be performed in a busy labor and delivery room, she said.

CHARLESTON, S.C. — Rapid real-time polymerase chain reaction testing for group B streptococcus detection proved at least as sensitive and specific as standard culture screening at 35–37 weeks' gestation in a recent study.

Two vaginal-rectal swabs were collected from each of 190 women enrolled in the study after presenting in labor. One sample was tested using the Food and Drug Administration-approved IDI-Strep B assay and analyzed using the FDA-approved Smart Cycler I instrument; the other sample was used for enriched culture for GBS, Deborah M. Money, M.D., reported at the annual meeting of the Infectious Diseases Society for Obstetrics and Gynecology.

In the more than 150 women in the study who also underwent the currently recommended 35- to 37-week culture screening and had results available for analysis, the rapid test had a sensitivity of 89%, compared with 85% for the 35- to 37-week culture, and a positive predictive value of 97%, compared with 94% for the 35- to 37-week culture. The values were based on comparison with culture at delivery, said Dr. Money of the University of British Columbia, Vancouver.

The median time from specimen acquisition to availability of results with the rapid test was 90 minutes, with a range of 30 minutes to 4 hours. About 87% of results were available within 2 hours; cultures can require a few days for results. Colonization rates were about 30% with both the rapid test and the culture, she said.

Theoretically, the rapid test could be used during labor to circumvent some of the potential problems inherent in the 35− to 37-week culture method of screening, such as its reliance on the provider to do the screening properly, the uncertainty of the availability of results by delivery (which can jeopardize the chance of a colonized patient receiving the recommended 4 hours of antibiotic therapy during labor for preventing vertical transmission), and the fact that some women do not have prenatal care and would therefore not present for the 35− to 37-week culture. But with the similar sensitivity and specificity to 35− to 37-week culture demonstrated by the rapid test in this study, its usefulness for routine care is unclear.

“We were a little surprised by the lack of superiority of PCR to the culture methodology,” said Dr. Money, adding that larger studies will be required to determine if there is a statistically significant sensitivity and cost advantage with the rapid test over the 35− to 37-week culture.

One setting in which the rapid test can be of particular use now, however, is in patients who present in labor without information regarding their group B strep status. For those patients, the test is feasible, it has a reasonable turnaround time and a comparable result to culture screening, and it can be performed in a busy labor and delivery room, she said.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps that physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America. (See box.)

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to circle the wagons with confirmation by the World Health Organization that the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU website.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Doug Campos-Outcalt, M.D., said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt, chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services. HHS is working to maintain open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species. Although there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, he said.

Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America, agreed there doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point.

As for recent press coverage of a leaked draft of the federal government's pandemic preparedness plan, which indicates the country is alarmingly unprepared for such a pandemic, Mr. Hall said only that the report has undergone and will continue to undergo revisions as the situation evolves.

The final report is anticipated, but its release won't be hastened in response to the flurry of media reports about the draft copy. “What drives us is not the media, but global health, and being as prepared as possible for a pandemic,” he said.

According to information from the World Health Organization, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic. Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

This scenario is the source of the sense of urgency that Mr. Hall mentioned.

At press time, WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread. The virus' ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency, as are the findings of a recent study of the 1918 influenza pandemic, which killed an estimated 50 million people. Researchers completed the virus coding sequence for the responsible virus and discovered that, like H5N1, the 1918 strain was a bird flu that infected humans (Science 2005;310:77–80).

The study's findings, coupled with the apparent staying power of the H5N1 strain (it has been circulating since 1997) and the fact that many experts say an influenza pandemic is overdue (historically such outbreaks occur about every 30 years, and the last occurred 37 years ago) contribute to the urgency in preparing for a pandemic.

That urgency is apparent in the flurry of government activity in response to the pandemic threat. The U.S. State Department recently hosted a meeting of senior health officials from nearly 70 countries to address the need for improved communications and efforts to prevent a pandemic. And President Bush has met with vaccine makers to urge increases in flu vaccine production.

Further, the Bush administration and Congress are considering spending billions to stockpile the antiviral drug Tamiflu, legislation has been introduced that would further ramp up vaccine production and pandemic preparedness, and the National Institute of Allergy and Infectious Diseases has teamed with MedImmune Inc. to develop and manufacture new influenza vaccines, including vaccines against high-priority strains such as H5N1.

But some experts have suggested that H5N1 does not confer a pandemic threat, saying that if it was going to develop the ability to efficiently transmit between people, then it would have done so by now, and that because the bird flu is distantly related to earlier flu viruses, much of the population already has some level of immunity.

Whether or not H5N1 becomes pandemic, preparing for a potential pandemic is warranted and worthwhile, say experts.

“Even if it does not materialize, the planning and development of effective interventions will provide the necessary preparations in the event that another avian strain jumps the species barrier or a known human pathogen like H2N2, to which large segments of the population lack immunity, reemerges,” John G. Bartlett, M.D., of Johns Hopkins University, Baltimore, and Frederick G. Hayden, M.D., University of Virginia Health Sciences Center, Charlottesville, Va., stated in a recent editorial (Ann. Intern. Med. 2005;143:460–2).

Preparations would also enhance the nation's ability to cope with annual epidemics and their substantial toll. Widespread vaccination and use of antiviral drugs could provide the foundation for responding to the next pandemic, thus warranting the stockpiling of antiviral agents, they wrote.

Giving Regular Flu Vaccine May Help

The most effective thing individual physicians can do is vaccinate patients against the currently circulating influenza strains, Dr. Poretz said.

Such vaccination will address the immediate concern of influenza outbreaks in the United States, and, according to guidelines from the WHO, could be useful for preventing co-infection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” Dr. Campos-Outcalt said.

Communication and surveillance will be the cornerstones of effective management, he added. This is where education for and by physicians becomes important.

Physicians need to stay up to date, because so much is unknown about how patients would present in the event of a pandemic. And physicians need to educate patients about the preventive measures that will become imperative should available vaccines and antivirals prove ineffective for the pandemic strain.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps that physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America. (See box.)

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to circle the wagons with confirmation by the World Health Organization that the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU website.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Doug Campos-Outcalt, M.D., said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt, chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services. HHS is working to maintain open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species. Although there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, he said.

Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America, agreed there doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point.

As for recent press coverage of a leaked draft of the federal government's pandemic preparedness plan, which indicates the country is alarmingly unprepared for such a pandemic, Mr. Hall said only that the report has undergone and will continue to undergo revisions as the situation evolves.

The final report is anticipated, but its release won't be hastened in response to the flurry of media reports about the draft copy. “What drives us is not the media, but global health, and being as prepared as possible for a pandemic,” he said.

According to information from the World Health Organization, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic. Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

This scenario is the source of the sense of urgency that Mr. Hall mentioned.

At press time, WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread. The virus' ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency, as are the findings of a recent study of the 1918 influenza pandemic, which killed an estimated 50 million people. Researchers completed the virus coding sequence for the responsible virus and discovered that, like H5N1, the 1918 strain was a bird flu that infected humans (Science 2005;310:77–80).

The study's findings, coupled with the apparent staying power of the H5N1 strain (it has been circulating since 1997) and the fact that many experts say an influenza pandemic is overdue (historically such outbreaks occur about every 30 years, and the last occurred 37 years ago) contribute to the urgency in preparing for a pandemic.

That urgency is apparent in the flurry of government activity in response to the pandemic threat. The U.S. State Department recently hosted a meeting of senior health officials from nearly 70 countries to address the need for improved communications and efforts to prevent a pandemic. And President Bush has met with vaccine makers to urge increases in flu vaccine production.

Further, the Bush administration and Congress are considering spending billions to stockpile the antiviral drug Tamiflu, legislation has been introduced that would further ramp up vaccine production and pandemic preparedness, and the National Institute of Allergy and Infectious Diseases has teamed with MedImmune Inc. to develop and manufacture new influenza vaccines, including vaccines against high-priority strains such as H5N1.

But some experts have suggested that H5N1 does not confer a pandemic threat, saying that if it was going to develop the ability to efficiently transmit between people, then it would have done so by now, and that because the bird flu is distantly related to earlier flu viruses, much of the population already has some level of immunity.

Whether or not H5N1 becomes pandemic, preparing for a potential pandemic is warranted and worthwhile, say experts.

“Even if it does not materialize, the planning and development of effective interventions will provide the necessary preparations in the event that another avian strain jumps the species barrier or a known human pathogen like H2N2, to which large segments of the population lack immunity, reemerges,” John G. Bartlett, M.D., of Johns Hopkins University, Baltimore, and Frederick G. Hayden, M.D., University of Virginia Health Sciences Center, Charlottesville, Va., stated in a recent editorial (Ann. Intern. Med. 2005;143:460–2).

Preparations would also enhance the nation's ability to cope with annual epidemics and their substantial toll. Widespread vaccination and use of antiviral drugs could provide the foundation for responding to the next pandemic, thus warranting the stockpiling of antiviral agents, they wrote.

Giving Regular Flu Vaccine May Help

The most effective thing individual physicians can do is vaccinate patients against the currently circulating influenza strains, Dr. Poretz said.

Such vaccination will address the immediate concern of influenza outbreaks in the United States, and, according to guidelines from the WHO, could be useful for preventing co-infection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” Dr. Campos-Outcalt said.

Communication and surveillance will be the cornerstones of effective management, he added. This is where education for and by physicians becomes important.

Physicians need to stay up to date, because so much is unknown about how patients would present in the event of a pandemic. And physicians need to educate patients about the preventive measures that will become imperative should available vaccines and antivirals prove ineffective for the pandemic strain.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps that physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America. (See box.)

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to circle the wagons with confirmation by the World Health Organization that the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU website.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Doug Campos-Outcalt, M.D., said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt, chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services. HHS is working to maintain open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species. Although there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, he said.

Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America, agreed there doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point.

As for recent press coverage of a leaked draft of the federal government's pandemic preparedness plan, which indicates the country is alarmingly unprepared for such a pandemic, Mr. Hall said only that the report has undergone and will continue to undergo revisions as the situation evolves.

The final report is anticipated, but its release won't be hastened in response to the flurry of media reports about the draft copy. “What drives us is not the media, but global health, and being as prepared as possible for a pandemic,” he said.

According to information from the World Health Organization, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic. Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

This scenario is the source of the sense of urgency that Mr. Hall mentioned.

At press time, WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread. The virus' ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency, as are the findings of a recent study of the 1918 influenza pandemic, which killed an estimated 50 million people. Researchers completed the virus coding sequence for the responsible virus and discovered that, like H5N1, the 1918 strain was a bird flu that infected humans (Science 2005;310:77–80).

The study's findings, coupled with the apparent staying power of the H5N1 strain (it has been circulating since 1997) and the fact that many experts say an influenza pandemic is overdue (historically such outbreaks occur about every 30 years, and the last occurred 37 years ago) contribute to the urgency in preparing for a pandemic.

That urgency is apparent in the flurry of government activity in response to the pandemic threat. The U.S. State Department recently hosted a meeting of senior health officials from nearly 70 countries to address the need for improved communications and efforts to prevent a pandemic. And President Bush has met with vaccine makers to urge increases in flu vaccine production.

Further, the Bush administration and Congress are considering spending billions to stockpile the antiviral drug Tamiflu, legislation has been introduced that would further ramp up vaccine production and pandemic preparedness, and the National Institute of Allergy and Infectious Diseases has teamed with MedImmune Inc. to develop and manufacture new influenza vaccines, including vaccines against high-priority strains such as H5N1.

But some experts have suggested that H5N1 does not confer a pandemic threat, saying that if it was going to develop the ability to efficiently transmit between people, then it would have done so by now, and that because the bird flu is distantly related to earlier flu viruses, much of the population already has some level of immunity.

Whether or not H5N1 becomes pandemic, preparing for a potential pandemic is warranted and worthwhile, say experts.

“Even if it does not materialize, the planning and development of effective interventions will provide the necessary preparations in the event that another avian strain jumps the species barrier or a known human pathogen like H2N2, to which large segments of the population lack immunity, reemerges,” John G. Bartlett, M.D., of Johns Hopkins University, Baltimore, and Frederick G. Hayden, M.D., University of Virginia Health Sciences Center, Charlottesville, Va., stated in a recent editorial (Ann. Intern. Med. 2005;143:460–2).

Preparations would also enhance the nation's ability to cope with annual epidemics and their substantial toll. Widespread vaccination and use of antiviral drugs could provide the foundation for responding to the next pandemic, thus warranting the stockpiling of antiviral agents, they wrote.

Giving Regular Flu Vaccine May Help

The most effective thing individual physicians can do is vaccinate patients against the currently circulating influenza strains, Dr. Poretz said.

Such vaccination will address the immediate concern of influenza outbreaks in the United States, and, according to guidelines from the WHO, could be useful for preventing co-infection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” Dr. Campos-Outcalt said.

Communication and surveillance will be the cornerstones of effective management, he added. This is where education for and by physicians becomes important.

Physicians need to stay up to date, because so much is unknown about how patients would present in the event of a pandemic. And physicians need to educate patients about the preventive measures that will become imperative should available vaccines and antivirals prove ineffective for the pandemic strain.

ST. PETE BEACH, FLA. — Maternal infection with the Epstein-Barr virus does not appear to represent a major teratogenic risk, Meytal Avgil, M.D., reported at the annual meeting of the Teratology Society.

The herpes virus—and the cause of infectious mononucleosis—has not been well studied in pregnancy, but in a recent prospective study, the rate of major anomalies was 5% in a group of more than 200 EBV-exposed pregnancies, and 3% in a group of nearly 1,200 controls. The difference between groups was not statistically significant, and the rates were within the expected baseline risk for the general population, said Dr. Avgil of Hebrew University, Jerusalem.

Furthermore, the anomalies did not follow any specific pattern in the EBV group, and were similar in the two groups, she noted.

There also were no differences in the rate of live births, miscarriages, or elective terminations of pregnancy between the two groups; the median birth weight of infants was similar in both groups, ranging from about 3,200–3,300 g. The median gestational age at delivery was 40 weeks in both groups.

ST. PETE BEACH, FLA. — Maternal infection with the Epstein-Barr virus does not appear to represent a major teratogenic risk, Meytal Avgil, M.D., reported at the annual meeting of the Teratology Society.

The herpes virus—and the cause of infectious mononucleosis—has not been well studied in pregnancy, but in a recent prospective study, the rate of major anomalies was 5% in a group of more than 200 EBV-exposed pregnancies, and 3% in a group of nearly 1,200 controls. The difference between groups was not statistically significant, and the rates were within the expected baseline risk for the general population, said Dr. Avgil of Hebrew University, Jerusalem.

Furthermore, the anomalies did not follow any specific pattern in the EBV group, and were similar in the two groups, she noted.

There also were no differences in the rate of live births, miscarriages, or elective terminations of pregnancy between the two groups; the median birth weight of infants was similar in both groups, ranging from about 3,200–3,300 g. The median gestational age at delivery was 40 weeks in both groups.

ST. PETE BEACH, FLA. — Maternal infection with the Epstein-Barr virus does not appear to represent a major teratogenic risk, Meytal Avgil, M.D., reported at the annual meeting of the Teratology Society.

The herpes virus—and the cause of infectious mononucleosis—has not been well studied in pregnancy, but in a recent prospective study, the rate of major anomalies was 5% in a group of more than 200 EBV-exposed pregnancies, and 3% in a group of nearly 1,200 controls. The difference between groups was not statistically significant, and the rates were within the expected baseline risk for the general population, said Dr. Avgil of Hebrew University, Jerusalem.

Furthermore, the anomalies did not follow any specific pattern in the EBV group, and were similar in the two groups, she noted.

There also were no differences in the rate of live births, miscarriages, or elective terminations of pregnancy between the two groups; the median birth weight of infants was similar in both groups, ranging from about 3,200–3,300 g. The median gestational age at delivery was 40 weeks in both groups.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America.

Such vaccination will address the immediate concern of influenza outbreaks in the United States and, according to World Health Organization guidelines, could be useful for preventing coinfection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” said Doug Campos-Outcalt, M.D., chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to rally after the confirmation by the WHO that, in addition to Asia, the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU Web site.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Dr. Campos-Outcalt said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt.

When it comes to potential patient requests for antiviral medications such as oseltamivir, “I would encourage physicians to prescribe as recommended by the CDC and the manufacturer,” said Dr. Campos-Outcalt. The CDC's influenza page is located at www.cdc.gov/flu/

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services.

HHS is maintaining open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species.

While there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, Mr. Hall said.

According to information from the WHO, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic.

Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

At press time, the WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread.

The virus's ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America.

Such vaccination will address the immediate concern of influenza outbreaks in the United States and, according to World Health Organization guidelines, could be useful for preventing coinfection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” said Doug Campos-Outcalt, M.D., chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to rally after the confirmation by the WHO that, in addition to Asia, the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU Web site.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Dr. Campos-Outcalt said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt.

When it comes to potential patient requests for antiviral medications such as oseltamivir, “I would encourage physicians to prescribe as recommended by the CDC and the manufacturer,” said Dr. Campos-Outcalt. The CDC's influenza page is located at www.cdc.gov/flu/

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services.

HHS is maintaining open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species.

While there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, Mr. Hall said.

According to information from the WHO, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic.

Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

At press time, the WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread.

The virus's ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency.

Warnings of a potential avian influenza pandemic have the nation and medical community on alert—but those who would be on the front lines appear to be taking the threat in stride.

One of the few concrete steps physicians can take at this time is to ensure that patients are vaccinated against conventional influenza strains, said Donald M. Poretz, M.D., vice president of the Infectious Diseases Society of America.

Such vaccination will address the immediate concern of influenza outbreaks in the United States and, according to World Health Organization guidelines, could be useful for preventing coinfection with H5N1 and a human influenza strain.

According to the WHO, doing so will decrease the opportunity for genetic reassortment of the avian H5N1 strain with genes from a human (H1 or H3) strain and thereby reduce the likelihood that a novel pandemic strain will emerge from the current situation in Asia.

If an avian influenza pandemic does occur, diagnosis could prove quite difficult, because the symptoms of H5N1 are similar to those of “regular flu,” said Doug Campos-Outcalt, M.D., chair of the department of family and community medicine at the University of Arizona, Phoenix, and former chair of the American Academy of Family Physicians' commission on clinical policy.

There doesn't appear to be—and there shouldn't be—major fear or panic in the United States regarding a pandemic at this point, he told this newspaper.

However, European Union (EU) public health experts have begun to rally after the confirmation by the WHO that, in addition to Asia, the H5N1 strain of the influenza virus has been isolated in poultry in Turkey and Romania, bringing the disease to Europe's doorstep. Among the steps taken by the EU was a ban on the importation of live birds, poultry meat, and other poultry products from Turkey and Romania, according to a statement posted on the EU Web site.

“We need to look at the information objectively, and not emotionally. I don't believe anyone can make a statement as to whether or not there will be a pandemic, but the likelihood is that there will be at some point, so one has to be prepared,” said Dr. Poretz, professor of medicine at Georgetown University in Washington.

Dr. Campos-Outcalt said that “everyone I know is fatalistic about it. Everyone knows it's coming, but it's difficult to prepare for.”

Beyond preventive hygiene measures, such as hand washing and covering one's mouth when coughing or sneezing, that are important for preventing transmission of any influenza virus, most preparations for a pandemic are “out of the hands of ordinary physicians,” said Dr. Campos-Outcalt.

When it comes to potential patient requests for antiviral medications such as oseltamivir, “I would encourage physicians to prescribe as recommended by the CDC and the manufacturer,” said Dr. Campos-Outcalt. The CDC's influenza page is located at www.cdc.gov/flu/

The watch-and-wait mode is an appropriate place for individual physicians to be right now, said Bill Hall, a spokesperson for the Department of Health and Human Services.

HHS is maintaining open lines of communication with public health departments, and through those departments is working to keep physicians informed of world events related to the spread of avian influenza—particularly the H5N1 strain that is rampant in Asia, has spread to numerous other areas, continues to mutate, and has jumped from birds to multiple other species.

While there is a sense of urgency, there is, at this point, no influenza strain that is causing a pandemic, thus there is no alert to physicians with regard to a pandemic, Mr. Hall said in an interview.

In fact, the only panic—as in people running through the streets with arms flailing—is occurring in the media, Mr. Hall said.

According to information from the WHO, IDSA, and various research projects, the H5N1 avian influenza strain does appear to have the potential for developing efficient person-to-person transmission capability, which it currently lacks, and which could be the bridge between the current situation and a future pandemic.

Should the virus obtain this capability, H5N1 could circle the globe within weeks or months, and could kill as many as 150 million people, according to a WHO estimate.

At press time, the WHO had confirmed 117 cases of human infection with H5N1 influenza, with cases in Vietnam, Thailand, Cambodia, and Indonesia. Human-to-human transmission has been documented in only two of those cases—both from a single household in Vietnam. The fatality rate among these cases is over 50%.

Infection in animals has been more widespread.

The virus's ability to mutate and infect additional species, including cats, leopards, tigers, and pigs, is another source of that urgency.

NEW ORLEANS — A recent series of “curious” cases of large vulvar or labial abscesses in previously healthy children were associated with methicillin-resistant Staphylococcus aureus and represent the first reported cases of such abscesses in the pediatric and adolescent population, S. Paige Hertweck, M.D., reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Six patients, aged 2, 16, and 17 months and 3, 12, and 16 years, presented during 2004 with vulvar or labial abscesses requiring debridement and drainage. All had confirmed S. aureus infection, and five of the patients had MRSA.

The MRSA cases presented initially with a red papule that progressed rapidly, and by day 2 a fulminant abscess extended significantly beyond the labia. The abscesses had an area greater than 5 cm.

After debridement and 48–72 hours of continuous drainage, all patients were treated with antibiotics. The use of small incisions at each end of the abscess cavities allowed digital manipulation, and the use of a small Penrose drain threaded through each incision and tied to itself allowed continuous drainage that negated the need for extensive packing, which can be difficult in children.

None of the children had typical risk factors for MRSA, although three did have household contacts with lesions that might have been associated with MRSA. All the infections were sensitive to clindamycin, Bactrim (trimethoprim-sulfamethoxazole), and vancomycin.

MRSA should be considered in all patients presenting with rapidly progressing vulvar or labial erythema. Aggressive treatment with incision and drainage in such cases is warranted, she said, noting that a limited incision site and the use of a Penrose drain are recommended in children.

Appropriate antibiotic therapy should also be initiated.

NEW ORLEANS — A recent series of “curious” cases of large vulvar or labial abscesses in previously healthy children were associated with methicillin-resistant Staphylococcus aureus and represent the first reported cases of such abscesses in the pediatric and adolescent population, S. Paige Hertweck, M.D., reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Six patients, aged 2, 16, and 17 months and 3, 12, and 16 years, presented during 2004 with vulvar or labial abscesses requiring debridement and drainage. All had confirmed S. aureus infection, and five of the patients had MRSA.

The MRSA cases presented initially with a red papule that progressed rapidly, and by day 2 a fulminant abscess extended significantly beyond the labia. The abscesses had an area greater than 5 cm.

After debridement and 48–72 hours of continuous drainage, all patients were treated with antibiotics. The use of small incisions at each end of the abscess cavities allowed digital manipulation, and the use of a small Penrose drain threaded through each incision and tied to itself allowed continuous drainage that negated the need for extensive packing, which can be difficult in children.

None of the children had typical risk factors for MRSA, although three did have household contacts with lesions that might have been associated with MRSA. All the infections were sensitive to clindamycin, Bactrim (trimethoprim-sulfamethoxazole), and vancomycin.

MRSA should be considered in all patients presenting with rapidly progressing vulvar or labial erythema. Aggressive treatment with incision and drainage in such cases is warranted, she said, noting that a limited incision site and the use of a Penrose drain are recommended in children.

Appropriate antibiotic therapy should also be initiated.

NEW ORLEANS — A recent series of “curious” cases of large vulvar or labial abscesses in previously healthy children were associated with methicillin-resistant Staphylococcus aureus and represent the first reported cases of such abscesses in the pediatric and adolescent population, S. Paige Hertweck, M.D., reported at the annual meeting of the North American Society for Pediatric and Adolescent Gynecology.

Six patients, aged 2, 16, and 17 months and 3, 12, and 16 years, presented during 2004 with vulvar or labial abscesses requiring debridement and drainage. All had confirmed S. aureus infection, and five of the patients had MRSA.

The MRSA cases presented initially with a red papule that progressed rapidly, and by day 2 a fulminant abscess extended significantly beyond the labia. The abscesses had an area greater than 5 cm.

After debridement and 48–72 hours of continuous drainage, all patients were treated with antibiotics. The use of small incisions at each end of the abscess cavities allowed digital manipulation, and the use of a small Penrose drain threaded through each incision and tied to itself allowed continuous drainage that negated the need for extensive packing, which can be difficult in children.

None of the children had typical risk factors for MRSA, although three did have household contacts with lesions that might have been associated with MRSA. All the infections were sensitive to clindamycin, Bactrim (trimethoprim-sulfamethoxazole), and vancomycin.

MRSA should be considered in all patients presenting with rapidly progressing vulvar or labial erythema. Aggressive treatment with incision and drainage in such cases is warranted, she said, noting that a limited incision site and the use of a Penrose drain are recommended in children.

Appropriate antibiotic therapy should also be initiated.

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, which is performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections, which are visible because of the methylene blue wheals that form at the injection sites, are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said. She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said. However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, which is performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections, which are visible because of the methylene blue wheals that form at the injection sites, are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said. She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said. However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.

ATLANTA — Botox may be the answer for women with detrusor overactivity incontinence who have failed to respond to conservative therapy.

A cystoscopic technique that uses intradetrusor injections of botulinum toxin A injections to decrease bladder muscle overactivity associated with this type of incontinence was demonstrated in a video presented by Sangeeta Mahajan, M.D., at the annual meeting of the American Urogynecologic Society.

The in-office procedure, which is performed under local anesthesia, is proving safe and effective for women with resistant incontinence—both those with neurogenic bladders and those with neurologically normal bladders—said Dr. Mahajan of MacDonald Women's Hospital, Cleveland, Ohio.

She and her colleagues use a flexible or rigid cystoscope and the Wolf collagen-injection system with disposable needles, although comparable systems can be used. A total of 30 cc of 1% lidocaine is instilled into the bladder for anesthesia.

An additional 10 cc of 2% lidocaine can be placed in the urethra for more anesthesia. The lidocaine is left in place for 10 minutes to allow adequate anesthesia, but it does not have to be removed before injecting the toxin.

The Botox (Allergan, Inc.) is prepared using injectable saline and methylene blue to allow visualization of injection sites, and is placed into two 3-cc syringes for a total of 200 units in 6 cc of saline.

Cystoscopy is performed in a routine fashion with adequate bladder distention to visualize the urothelium. An initial Botox injection is completed at the midline of the bladder, just above the trigone, and the scope is carefully moved laterally left or right to allow additional injections at 4- to 5-cm intervals until four or five have been completed. Mirror-image injections are then performed on the opposite side, followed by a second row of injections 1 cm above the first row, for a total of about 20 injections.

Additional rows may be needed to disperse the total amount of toxin throughout the posterior bladder wall. Care should be taken not to inject the trigone to prevent any possible risk of urethral reflux due to toxin exposure.

A final survey of the bladder wall will ensure that the injections, which are visible because of the methylene blue wheals that form at the injection sites, are well distributed.

Cystoscopy is then completed, and the bladder is drained. The patient should be monitored for 15 minutes, during which time she can be instructed on the use of intermittent self-catheterization, which may be needed if urinary retention occurs in the weeks after treatment. An appropriate urinary antibiotic is prescribed for 3 days.

The procedure is well tolerated and is technically feasible in the office setting, Dr. Mahajan said. She and her colleagues have performed the procedure on 50–60 patients, and other centers in the United States have been using it for several years.

“Patients are so happy—[the procedure] revolutionizes their lives,” she said, noting that these are patients who have failed all other treatment, including medical, behavioral, and physical therapy.

This technique provides an alternative to major surgery such as sacral neuromodulation or urinary diversion, she said. However, it has been studied in a randomized, controlled setting only in Europe and only in patients with neurogenic bladders.

Interim results of an open-label trial in Europe in women with neurologically normal bladders were presented last year by Dr. Bernhard Schuessler of Cantonal Hospital, Lucerne, Switzerland, at another meeting of the American Urogynecologic Society, and also showed that the treatment was safe and effective.

A randomized trial in the United States is also in the works, and will be conducted by the National Institutes of Health-funded Pelvic Floor Disorders Network in a neurologically normal population of women.