Therapeutics
In women with stress urinary incontinence, initial surgery was more effective than physiotherapy
Labrie J, Berghmans BL, Fischer K, et al. Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med. 2013;369:1124-33.
Clinical impact ratings: F ★★★★★✩✩ G ★★★★★★★ Question What is the relative efficacy of midurethral-sling surgery and physiotherapy as initial therapy in women with moderate-to-severe stress urinary incontinence (SUI)?
Methods Design: Randomized controlled trial. Dutch Trial Register NTR1248. Allocation: Concealed.* Blinding: Unblinded.* Follow-up period: 12 months (primary outcome) and 18 months. Setting: 4 university medical centers and 19 general hospitals in the Netherlands. Patients: 460 women 35 to 80 years of age (mean age 50 y) who were referred to an outpatient gynecology or urology clinic for moderate-to-severe SUI (urine leakage on straining or coughing at bladder volume ≥ 300 mL) and had no previous treatment or no physiotherapy in the past 6 months. Women with both SUI and urge urinary incontinence were included if stress incontinence was more frequent. Exclusion criteria were ≥ stage 2 pelvic-organ prolapse or previous surgery for incontinence. Intervention: Retropubic or transobturator midurethral-sling surgery (n = 230) or a supervised program of 9 physiotherapy sessions done over 9 to 18 weeks and including pelvic-floor muscle training, with the aim of achieving 8 to 12 maximal contractions 3 times daily (n = 230). Outcomes: Subjective symptom improvement (“much better” or “very much better” on the 7-point Patient Global Impression of Improvement scale). Other outcomes included subjective cure based on response to the question, “Do you experience urine leakage related to physical activity, coughing, or sneezing?”, and adverse events. Objective cure (cough stress test with no incontinence at bladder volume ≥ 300 mL) was evaluated in < 75% of women and is not reported here. Patient follow-up: 80% at 12 months (intention-to-treat [ITT] analysis).
Main results At 12 months, 49% of the physiotherapy group had crossed over to surgery, and 11% of the surgery group had crossed over to physiotherapy. Initial midurethral-sling surgery improved subjective symptoms and increased subjective cure rate compared with initial physiotherapy (Table). 9.8% of the 417 women treated Initial midurethral-sling surgery vs physiotherapy in women with moderate-to-severe SUI† Outcomes
Surgery
Physiotherapy
At 12 mo RBI (95% CI) NNT (CI)
Subjective symptom improvement‡
91%
64%
41% (26 to 60)
4 (3 to 6)
Subjective cure§
85%
53%
59% (38 to 87)
4 (3 to 5)
†SUI = stress urinary incontinence; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article. ‡Patient Global Impression of Improvement 7-point scale = “much better” or “very much better.” §Based on response to 1 question.
18 February 2014 | ACP Journal Club | Volume 160 • Number 4
had adverse events; all were surgery-related, including hematoma (4.8% of women), new urge urinary incontinence (4.3%), and vaginal epithelial perforation (2.4%).
Conclusion In women with moderate-to-severe stress urinary incontinence, initial midurethral-sling surgery improved symptoms at 1 year compared with initial physiotherapy. *See Glossary.
Source of funding: ZonMw, the Netherlands Organization for Health Research and Development. For correspondence: Dr. J. Labrie, University Medical Centre Utrecht, Utrecht, The Netherlands. E-mail [email protected]. ■
Commentary Labrie and colleagues compared the effectiveness of pelvic-floor muscle training and midurethral-sling surgery as initial treatment options for SUI. Based on the ITT analysis, they concluded that initial midurethral-sling surgery (retropubic or transobturator polypropylene tape) increased subjective improvement rates and both subjective and objective cure at 1 year in women with SUI. In a post hoc analysis of 3 groups—initial surgery, initial physiotherapy without crossover to surgery, and initial physiotherapy with crossover to surgery—the difference in outcomes favored the 2 surgery groups. There are several points to consider before using surgery as firstline therapy for SUI. First, although the study by Labrie and colleagues included women up to 80 years of age, the mean age was 50 years, and results were not stratified by age group. Applicability of the results to older women (age > 65 y) is unclear because mixed urinary incontinence may be more common in older patients. However, the efficacy of physiotherapy seems similar in younger and older women (1). Second, women who had initial surgery or surgery after physiotherapy had many important adverse events, including intraoperative bladder perforations (6 events), repeated operations (7 events), vaginal epithelial perforations, and another form of incontinence after surgery. Third, the quality of physiotherapy offered in the study may exceed that commonly available in the USA and Canada. Fourth, in patients with mixed stress and urge urinary incontinence, physiotherapy can improve both (2), whereas the midurethral sling only helps stress incontinence. Finally, physiotherapy does not affect the outcome of surgery done at a later date. Physiotherapy should be the first-line therapy for SUI for the following reasons: 1) 64% of women randomized to physiotherapy reported symptom improvement; 2) physiotherapy is curative for some women, has no risk for adverse events, and is safer, less expensive, and less invasive than surgery; and 3) long-term continued benefits with midurethral sling surgery are not known. Nasseer A. Masoodi, MD, MBA, FACP The Villages Health System The Villages, Florida, USA References 1. Fan HL, Chan SS, Law TS, Cheung RY, Chung TK. Aust N Z J Obstet Gynaecol. 2013;53:298-304. 2. Burgio KL. Curr Urol Rep. 2013;14:457−64.
© 2014 American College of Physicians
Downloaded From: https://annals.org/pdfaccess.ashx?url=/data/journals/aim/929769/ by a Universite Laval Biblioteque User on 08/03/2017
JC7
In women with stress urinary incontinence, initial surgery was more effective than physiotherapy
Labrie J, Berghmans BL, Fischer K, et al. Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med. 2013;369:1124-33.
Clinical impact ratings: F ★★★★★✩✩ G ★★★★★★★ Question What is the relative efficacy of midurethral-sling surgery and physiotherapy as initial therapy in women with moderate-to-severe stress urinary incontinence (SUI)?
Methods Design: Randomized controlled trial. Dutch Trial Register NTR1248. Allocation: Concealed.* Blinding: Unblinded.* Follow-up period: 12 months (primary outcome) and 18 months. Setting: 4 university medical centers and 19 general hospitals in the Netherlands. Patients: 460 women 35 to 80 years of age (mean age 50 y) who were referred to an outpatient gynecology or urology clinic for moderate-to-severe SUI (urine leakage on straining or coughing at bladder volume ≥ 300 mL) and had no previous treatment or no physiotherapy in the past 6 months. Women with both SUI and urge urinary incontinence were included if stress incontinence was more frequent. Exclusion criteria were ≥ stage 2 pelvic-organ prolapse or previous surgery for incontinence. Intervention: Retropubic or transobturator midurethral-sling surgery (n = 230) or a supervised program of 9 physiotherapy sessions done over 9 to 18 weeks and including pelvic-floor muscle training, with the aim of achieving 8 to 12 maximal contractions 3 times daily (n = 230). Outcomes: Subjective symptom improvement (“much better” or “very much better” on the 7-point Patient Global Impression of Improvement scale). Other outcomes included subjective cure based on response to the question, “Do you experience urine leakage related to physical activity, coughing, or sneezing?”, and adverse events. Objective cure (cough stress test with no incontinence at bladder volume ≥ 300 mL) was evaluated in < 75% of women and is not reported here. Patient follow-up: 80% at 12 months (intention-to-treat [ITT] analysis).
Main results At 12 months, 49% of the physiotherapy group had crossed over to surgery, and 11% of the surgery group had crossed over to physiotherapy. Initial midurethral-sling surgery improved subjective symptoms and increased subjective cure rate compared with initial physiotherapy (Table). 9.8% of the 417 women treated Initial midurethral-sling surgery vs physiotherapy in women with moderate-to-severe SUI† Outcomes
Surgery
Physiotherapy
At 12 mo RBI (95% CI) NNT (CI)
Subjective symptom improvement‡
91%
64%
41% (26 to 60)
4 (3 to 6)
Subjective cure§
85%
53%
59% (38 to 87)
4 (3 to 5)
†SUI = stress urinary incontinence; other abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article. ‡Patient Global Impression of Improvement 7-point scale = “much better” or “very much better.” §Based on response to 1 question.
18 February 2014 | ACP Journal Club | Volume 160 • Number 4
had adverse events; all were surgery-related, including hematoma (4.8% of women), new urge urinary incontinence (4.3%), and vaginal epithelial perforation (2.4%).
Conclusion In women with moderate-to-severe stress urinary incontinence, initial midurethral-sling surgery improved symptoms at 1 year compared with initial physiotherapy. *See Glossary.
Source of funding: ZonMw, the Netherlands Organization for Health Research and Development. For correspondence: Dr. J. Labrie, University Medical Centre Utrecht, Utrecht, The Netherlands. E-mail [email protected]. ■
Commentary Labrie and colleagues compared the effectiveness of pelvic-floor muscle training and midurethral-sling surgery as initial treatment options for SUI. Based on the ITT analysis, they concluded that initial midurethral-sling surgery (retropubic or transobturator polypropylene tape) increased subjective improvement rates and both subjective and objective cure at 1 year in women with SUI. In a post hoc analysis of 3 groups—initial surgery, initial physiotherapy without crossover to surgery, and initial physiotherapy with crossover to surgery—the difference in outcomes favored the 2 surgery groups. There are several points to consider before using surgery as firstline therapy for SUI. First, although the study by Labrie and colleagues included women up to 80 years of age, the mean age was 50 years, and results were not stratified by age group. Applicability of the results to older women (age > 65 y) is unclear because mixed urinary incontinence may be more common in older patients. However, the efficacy of physiotherapy seems similar in younger and older women (1). Second, women who had initial surgery or surgery after physiotherapy had many important adverse events, including intraoperative bladder perforations (6 events), repeated operations (7 events), vaginal epithelial perforations, and another form of incontinence after surgery. Third, the quality of physiotherapy offered in the study may exceed that commonly available in the USA and Canada. Fourth, in patients with mixed stress and urge urinary incontinence, physiotherapy can improve both (2), whereas the midurethral sling only helps stress incontinence. Finally, physiotherapy does not affect the outcome of surgery done at a later date. Physiotherapy should be the first-line therapy for SUI for the following reasons: 1) 64% of women randomized to physiotherapy reported symptom improvement; 2) physiotherapy is curative for some women, has no risk for adverse events, and is safer, less expensive, and less invasive than surgery; and 3) long-term continued benefits with midurethral sling surgery are not known. Nasseer A. Masoodi, MD, MBA, FACP The Villages Health System The Villages, Florida, USA References 1. Fan HL, Chan SS, Law TS, Cheung RY, Chung TK. Aust N Z J Obstet Gynaecol. 2013;53:298-304. 2. Burgio KL. Curr Urol Rep. 2013;14:457−64.
© 2014 American College of Physicians
Downloaded From: https://annals.org/pdfaccess.ashx?url=/data/journals/aim/929769/ by a Universite Laval Biblioteque User on 08/03/2017
JC7
