OBJECTIVES: This prospective, randomised study investigated whether a prophylactic procedure, performed during colposacropexy for prolapse repair, prevents ex novo postoperative incontinence. Sixty-six consecutive continent patients with advanced prolapse were randomised into two groups: group A underwent sacropexy combined with a Burch colposuspension; no anti-incontinence procedure was performed in group B patients. METHODS: Work-up included clinical assessment (Halfway System and International Continence Society [ICS] classification for prolapse and Ingelman Sunderberg scale for incontinence), the Urogenital Distress Inventory and Impact Incontinence Quality of Life questionnaires, urogynaecologic ultrasound scans, and complete urodynamic testing that included the urethral pressure profile and Valsalva leak point pressure with reduced prolapse. Check-ups were done at 3, 6, 12 mo postoperatively and then yearly. Mean follow-up time was 39.5 mo. RESULTS: The mean age (+/- standard deviation) was 62+/-9 yr. All patients presented with grade (G) 3-4 prolapse. Postoperative incontinence was present in 12 of the 34 patients in group A: 7 G1; 4 G2, and 1 G3. Postoperative incontinence was present in 3 of the 32 patients in group B: 2 G1, 1 G3. The frequency of postoperative incontinence was significantly greater in patients who had undergone colposuspension (p<0.05). CONCLUSIONS: These preliminary data cast doubt on whether colposuspension should be performed during sacropexy for severe urogenital prolapse as prophylaxis for postoperative incontinence because it seems to emerge as overtreatment. Incontinence developed ex novo in 35% of continent patients treated with colposuspension combined with sacropexy.
RCT Entities:
OBJECTIVES: This prospective, randomised study investigated whether a prophylactic procedure, performed during colposacropexy for prolapse repair, prevents ex novo postoperative incontinence. Sixty-six consecutive continent patients with advanced prolapse were randomised into two groups: group A underwent sacropexy combined with a Burch colposuspension; no anti-incontinence procedure was performed in group B patients. METHODS: Work-up included clinical assessment (Halfway System and International Continence Society [ICS] classification for prolapse and Ingelman Sunderberg scale for incontinence), the Urogenital Distress Inventory and Impact Incontinence Quality of Life questionnaires, urogynaecologic ultrasound scans, and complete urodynamic testing that included the urethral pressure profile and Valsalva leak point pressure with reduced prolapse. Check-ups were done at 3, 6, 12 mo postoperatively and then yearly. Mean follow-up time was 39.5 mo. RESULTS: The mean age (+/- standard deviation) was 62+/-9 yr. All patients presented with grade (G) 3-4 prolapse. Postoperative incontinence was present in 12 of the 34 patients in group A: 7 G1; 4 G2, and 1 G3. Postoperative incontinence was present in 3 of the 32 patients in group B: 2 G1, 1 G3. The frequency of postoperative incontinence was significantly greater in patients who had undergone colposuspension (p<0.05). CONCLUSIONS: These preliminary data cast doubt on whether colposuspension should be performed during sacropexy for severe urogenital prolapse as prophylaxis for postoperative incontinence because it seems to emerge as overtreatment. Incontinence developed ex novo in 35% of continent patients treated with colposuspension combined with sacropexy.