User login
Which treatments for pelvic floor disorders are backed by evidence?
EXPERT COMMENTARY
Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:
- assessing the patient’s symptoms and determining how bothersome they are
- educating the patient about her condition and the options for treatment
- initiating treatment with the most conservative and least invasive therapies.
Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,1 and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.2 Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.
Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.
Details of the studies
PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.
At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).
Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.
The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.
One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.
Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.
Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).
After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.
Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.
Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.
--Meadow M. Good, DO
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Wu JM, Matthews CA, Conover MM, Pate V, Funk MJ. Lifetime risk of stress incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201–1206.
- Nager C, Tulikangas P, Miller D, Rovner E, Goldman H. Position statement on mesh midurethral slings for stress urinary incontinence. Female Pelvic Med Reconstr Surg. 2014;20(3):123–125.
EXPERT COMMENTARY
Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:
- assessing the patient’s symptoms and determining how bothersome they are
- educating the patient about her condition and the options for treatment
- initiating treatment with the most conservative and least invasive therapies.
Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,1 and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.2 Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.
Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.
Details of the studies
PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.
At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).
Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.
The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.
One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.
Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.
Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).
After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.
Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.
Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.
--Meadow M. Good, DO
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
Care of women with pelvic floor disorders, primarily urinary incontinence and POP, involves:
- assessing the patient’s symptoms and determining how bothersome they are
- educating the patient about her condition and the options for treatment
- initiating treatment with the most conservative and least invasive therapies.
Safe treatments include PFMT and pessaries, and both can be effective. However, since approximately 25% of women experience one or more pelvic floor disorders during their life, surgical repair of these disorders is common. The lifetime risk of surgery for stress urinary incontinence (SUI) or POP is 20%,1 and one-third of patients will undergo reoperation for the same condition. Midurethral mesh slings are the gold standard for surgical management of SUI.2 Use of transvaginal mesh for primary prolapse repairs, however, is associated with challenging adverse effects, and its use should be reserved for carefully selected patients.
Data from 3 recent studies contribute to our evidence base on various treatments for pelvic floor disorders.
Details of the studies
PFMT for secondary prevention of POP. In a study conducted in the United Kingdom and New Zealand, Hagen and colleagues randomly assigned 414 women with POP, with or without symptoms, to an intervention group or a control group. The women had previously participated in a longitudinal study of postpartum pelvic floor function. Participants in the intervention group (n = 207) received 5 formal sessions of PFMT over 16 weeks, followed by Pilates-based classes focused on pelvic floor exercises; those in the control group (n = 207) received an informational leaflet about prolapse and lifestyle. The primary outcome was self-reported prolapse symptoms, assessed with the POP Symptom Score (POP-SS) at 2 years.
At study end, the mean (SD) POP-SS score in the intervention group was 3.2 (3.4), compared with a mean (SD) score of 4.2 (4.4) in the control group (adjusted mean difference, −1.01; 95% confidence interval [CI], −1.70 to −0.33; P = .004).
Investigators’ interpretation. The researchers concluded that the participants in the PFMT group had a small but significant—and clinically important—decrease in prolapse symptoms.
The PROSPECT study: Standard versus augmented surgical repair. In a multicenter trial in the United Kingdom by Glazener and associates, 1,352 women with symptomatic POP were randomly allocated to surgical repair with native tissue alone (standard repair) or to standard surgical repair augmented either with polypropylene mesh or with biological graft. The primary outcomes were participant-reported prolapse symptoms (assessed with POP-SS) and prolapse-related quality of life scores; these were measured at 1 year and at 2 years.
One year after surgery, failure rates (defined as prolapse beyond the hymen) were similar in all groups (range, 14%–18%); serious adverse events were also similar in all surgical groups (range, 6%–10%). Overall, 6% of women underwent reoperation for recurrent symptoms. Among women randomly assigned to repair with mesh, 12% to 14% experienced mesh-related adverse events; three-quarters of these women ultimately required surgical excision of the mesh.
Study takeaway. Thus, in terms of effectiveness, quality of life, and adverse effects, augmentation of a vaginal surgical repair with either mesh or graft material did not improve the outcomes of women with POP.
Adverse events after surgical procedures for pelvic floor disorders. In Scotland, Morling and colleagues performed a retrospective observational cohort study of first-time surgeries for SUI (mesh or colposuspension; 16,660 procedures) and prolapse (mesh or native tissue; 18,986 procedures).
After 5 years of follow-up, women who underwent midurethral mesh sling placement or colposuspension had similar rates of repeat surgery for recurrent SUI (adjusted incidence rate ratio, 0.90; 95% CI, 0.73–1.11). Use of mesh slings was associated with fewer immediate complications (adjusted relative risk, 0.44; 95% CI, 0.36–0.55) compared with nonmesh surgery.
Among women who underwent surgery for prolapse, those who had anterior and posterior repair with mesh experienced higher late complication rates than those who underwent native tissue repair. Risk for subsequent prolapse repair was similar with mesh and native-tissue procedures.
Authors’ commentary. The researchers noted that their data support the use of mesh procedures for incontinence but additional research on longer-term outcomes would be useful. However, for prolapse repair, the study results do not decidedly favor any one vault repair procedure.
--Meadow M. Good, DO
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Wu JM, Matthews CA, Conover MM, Pate V, Funk MJ. Lifetime risk of stress incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201–1206.
- Nager C, Tulikangas P, Miller D, Rovner E, Goldman H. Position statement on mesh midurethral slings for stress urinary incontinence. Female Pelvic Med Reconstr Surg. 2014;20(3):123–125.
- Wu JM, Matthews CA, Conover MM, Pate V, Funk MJ. Lifetime risk of stress incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014;123(6):1201–1206.
- Nager C, Tulikangas P, Miller D, Rovner E, Goldman H. Position statement on mesh midurethral slings for stress urinary incontinence. Female Pelvic Med Reconstr Surg. 2014;20(3):123–125.
Which vaginal procedure is best for uterine prolapse?
More than one-third of women aged 45 years or older experience uterine prolapse, a condition that can impair physical, psychological, and sexual function. To compare vaginal vault suspension with hysterectomy, investigators at 4 large Dutch teaching hospitals from 2009 to 2012 randomly assigned women with uterine prolapse to sacrospinous hysteropexy (SSLF) or vaginal hysterectomy with uterosacral ligament suspension (ULS). The primary outcome was recurrent stage 2 or greater prolapse (within 1 cm or more of the hymenal ring) with bothersome bulge symptoms or repeat surgery for prolapse by 12 months follow-up.
Details of the trialOne hundred two women assigned to SSLF (median age, 62.7 years) and 100 assigned to hysterectomy with ULS (median age, 61.9 years) were analyzed for the primary outcome. The patients ranged in age from 33 to 85 years.
Surgical failure rates and adverse events were similarMean hospital stay was 3 days in both groups and the occurrence of urinary retention was likewise similar (15% for SSLF and 11% for hysterectomy with ULS). At 12 months, 0 and 4 women in the SSLF and hysterectomy with ULS groups, respectively, met the primary outcome. Study participants were considered a “surgical failure” if any type of prolapse with bothersome symptoms or repeat surgery or pessary use occurred. Failures occurred in approximately one-half of the women in both groups.
Rates of serious adverse events were low, and none were related to type of surgery. Nine women experienced buttock pain following SSLF hysteropexy, a known complication of this surgery. This pain resolved within 6 weeks in 8 of these women. In the remaining woman, persistent pain led to release of the hysteropexy suture and vaginal hysterectomy 4 months after her initial procedure.
What this evidence means for practice
Advantages of hysterectomy at the time of vaginal vault suspension include prevention of endometrial and cervical cancers as well as elimination of uterine bleeding. However, data from published surveys indicate that many US women with prolapse prefer to avoid hysterectomy if effective alternate surgeries are available.1
In the previously published 2014 Barber and colleagues’ OPTIMAL trial,1,2 the efficacy of vaginal hysterectomy with either SSLF or USL was equivalent (63.1% versus 64.5%, respectively). The success rates are lower for both procedures in this trial by Detollenaere and colleagues.
Both SSLF and ULS may result in life-altering buttock or leg pain, necessitating removal of the offending sutures; however, the ULS procedure offers a more anatomically correct result. Although the short follow-up interval represents a limitation, these trial results suggest that sacrospinous fixation without hysterectomy represents a reasonable option for women with bothersome uterine prolapse who would like to avoid hysterectomy.
—Meadow M. Good, DO, and Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Korbly N, Kassis N, Good MM, et al. Patient preference for uterine preservation in women with pelvic organ prolapse: a fellow’s pelvic network research study. Am J Obstet Gynecol. 2013;209(5):470.e1−e6.
- Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse. The OPTIMAL randomized trial. JAMA. 2014;311(10):1023–1034.
More than one-third of women aged 45 years or older experience uterine prolapse, a condition that can impair physical, psychological, and sexual function. To compare vaginal vault suspension with hysterectomy, investigators at 4 large Dutch teaching hospitals from 2009 to 2012 randomly assigned women with uterine prolapse to sacrospinous hysteropexy (SSLF) or vaginal hysterectomy with uterosacral ligament suspension (ULS). The primary outcome was recurrent stage 2 or greater prolapse (within 1 cm or more of the hymenal ring) with bothersome bulge symptoms or repeat surgery for prolapse by 12 months follow-up.
Details of the trialOne hundred two women assigned to SSLF (median age, 62.7 years) and 100 assigned to hysterectomy with ULS (median age, 61.9 years) were analyzed for the primary outcome. The patients ranged in age from 33 to 85 years.
Surgical failure rates and adverse events were similarMean hospital stay was 3 days in both groups and the occurrence of urinary retention was likewise similar (15% for SSLF and 11% for hysterectomy with ULS). At 12 months, 0 and 4 women in the SSLF and hysterectomy with ULS groups, respectively, met the primary outcome. Study participants were considered a “surgical failure” if any type of prolapse with bothersome symptoms or repeat surgery or pessary use occurred. Failures occurred in approximately one-half of the women in both groups.
Rates of serious adverse events were low, and none were related to type of surgery. Nine women experienced buttock pain following SSLF hysteropexy, a known complication of this surgery. This pain resolved within 6 weeks in 8 of these women. In the remaining woman, persistent pain led to release of the hysteropexy suture and vaginal hysterectomy 4 months after her initial procedure.
What this evidence means for practice
Advantages of hysterectomy at the time of vaginal vault suspension include prevention of endometrial and cervical cancers as well as elimination of uterine bleeding. However, data from published surveys indicate that many US women with prolapse prefer to avoid hysterectomy if effective alternate surgeries are available.1
In the previously published 2014 Barber and colleagues’ OPTIMAL trial,1,2 the efficacy of vaginal hysterectomy with either SSLF or USL was equivalent (63.1% versus 64.5%, respectively). The success rates are lower for both procedures in this trial by Detollenaere and colleagues.
Both SSLF and ULS may result in life-altering buttock or leg pain, necessitating removal of the offending sutures; however, the ULS procedure offers a more anatomically correct result. Although the short follow-up interval represents a limitation, these trial results suggest that sacrospinous fixation without hysterectomy represents a reasonable option for women with bothersome uterine prolapse who would like to avoid hysterectomy.
—Meadow M. Good, DO, and Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
More than one-third of women aged 45 years or older experience uterine prolapse, a condition that can impair physical, psychological, and sexual function. To compare vaginal vault suspension with hysterectomy, investigators at 4 large Dutch teaching hospitals from 2009 to 2012 randomly assigned women with uterine prolapse to sacrospinous hysteropexy (SSLF) or vaginal hysterectomy with uterosacral ligament suspension (ULS). The primary outcome was recurrent stage 2 or greater prolapse (within 1 cm or more of the hymenal ring) with bothersome bulge symptoms or repeat surgery for prolapse by 12 months follow-up.
Details of the trialOne hundred two women assigned to SSLF (median age, 62.7 years) and 100 assigned to hysterectomy with ULS (median age, 61.9 years) were analyzed for the primary outcome. The patients ranged in age from 33 to 85 years.
Surgical failure rates and adverse events were similarMean hospital stay was 3 days in both groups and the occurrence of urinary retention was likewise similar (15% for SSLF and 11% for hysterectomy with ULS). At 12 months, 0 and 4 women in the SSLF and hysterectomy with ULS groups, respectively, met the primary outcome. Study participants were considered a “surgical failure” if any type of prolapse with bothersome symptoms or repeat surgery or pessary use occurred. Failures occurred in approximately one-half of the women in both groups.
Rates of serious adverse events were low, and none were related to type of surgery. Nine women experienced buttock pain following SSLF hysteropexy, a known complication of this surgery. This pain resolved within 6 weeks in 8 of these women. In the remaining woman, persistent pain led to release of the hysteropexy suture and vaginal hysterectomy 4 months after her initial procedure.
What this evidence means for practice
Advantages of hysterectomy at the time of vaginal vault suspension include prevention of endometrial and cervical cancers as well as elimination of uterine bleeding. However, data from published surveys indicate that many US women with prolapse prefer to avoid hysterectomy if effective alternate surgeries are available.1
In the previously published 2014 Barber and colleagues’ OPTIMAL trial,1,2 the efficacy of vaginal hysterectomy with either SSLF or USL was equivalent (63.1% versus 64.5%, respectively). The success rates are lower for both procedures in this trial by Detollenaere and colleagues.
Both SSLF and ULS may result in life-altering buttock or leg pain, necessitating removal of the offending sutures; however, the ULS procedure offers a more anatomically correct result. Although the short follow-up interval represents a limitation, these trial results suggest that sacrospinous fixation without hysterectomy represents a reasonable option for women with bothersome uterine prolapse who would like to avoid hysterectomy.
—Meadow M. Good, DO, and Andrew M. Kaunitz, MD
Share your thoughts on this article! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Korbly N, Kassis N, Good MM, et al. Patient preference for uterine preservation in women with pelvic organ prolapse: a fellow’s pelvic network research study. Am J Obstet Gynecol. 2013;209(5):470.e1−e6.
- Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse. The OPTIMAL randomized trial. JAMA. 2014;311(10):1023–1034.
- Korbly N, Kassis N, Good MM, et al. Patient preference for uterine preservation in women with pelvic organ prolapse: a fellow’s pelvic network research study. Am J Obstet Gynecol. 2013;209(5):470.e1−e6.
- Barber MD, Brubaker L, Burgio KL, et al. Comparison of 2 transvaginal surgical approaches and perioperative behavioral therapy for apical vaginal prolapse. The OPTIMAL randomized trial. JAMA. 2014;311(10):1023–1034.
