4 Efficacy

Guidance

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a systematic review and meta-analysis of 3,414 women from 30 randomised control trials (RCTs) comparing surgery for apical pelvic organ prolapse, 16 studies compared surgery for vaginal vault prolapse. In 3 RCTs (n=277) sacrocolpopexy (SCP) had a statistically significantly lower rate of subjective failure than vaginal procedures (7% [10/139] for SCP compared with 16% [22/138] for vaginal procedures, risk ratio [RR] 2.11; 95% confidence interval [CI] 1.06 to 4.21, I²=0%). The use of mesh or biological graft for SCP did not affect the subjective failure rate. Adding colposuspension to SCP did not alter subjective failure rate in a 7‑year follow-up study.

4.2 In 4 RCTs (n=390) from the systematic review of 3,414 women, SCP was associated with statistically significantly less recurrent prolapse than vaginal procedures at 1 to 2-year follow-up (19% [35/189] compared with 34% [68/201], RR 1.89; 95% CI 1.33 to 2.70, I²=41%). The use of mesh or biological graft did not affect the incidence of recurrent prolapse. Recurrent prolapse was not statistically significantly different between SCP and robot-assisted sacrocolpopexy (RASC) when compared with laparoscopic sacrocolpopexy (LSC). Adding colposuspension to SCP did not alter the incidence of recurrent prolapse. In 4 RCTs from a systematic review of 1,176 women, SCP using mesh had statistically significantly better objective cure rates than native tissue vaginal repair (75% [132/177] compared with 62% [119/192], odds ratio (OR) 2.04; 95% CI 1.12 to 3.72, I²=31%) at 1 to 2.5-year follow-up. In a systematic review and meta-analysis of 1,488 women, all-compartment prolapse was 6% (66/1,029) at a minimum 2-year follow-up. In an RCT of 100 women comparing SCP using polypropylene mesh with SCP using cadaveric fascia lata, overall objective anatomic success was statistically significantly higher in the polypropylene group (93% [27/29]) than in the fascia lata group (62% [18/29], p=0.02) at 5-year follow-up. In a case series of 165 women treated by LSC there was recurrent vault prolapse in 5% (7/138) of women, recurrent rectocele in 1% (1/138) and cystocele in 4% (5/138) of women at 8-year follow-up.

4.3 In 2 RCTs (n=199) from the systematic review of 3,414 women, the rate of anterior compartment prolapse was statistically significantly less frequent in women treated by SCP than in women treated by vaginal procedures (6% [6/102] compared with 24% [23/97], RR 4.02; 95% CI 1.71 to 9.49, I²=22%).

4.4 In 3 RCTs (n=275) from the systematic review of 3,414 women, apical compartment prolapse was statistically significantly less frequent in women treated by SCP than in women treated by vaginal procedures (2% [3/134] compared with 21% [29/141], RR 8.15; 95% CI 2.71 to 24.49, I²=0%). In the systematic review and meta-analysis of 1,488 women, apical prolapse rate was less than 1% (2/246).

4.5 In 2 RCTs (n=199) posterior compartment prolapse was statistically significantly less frequent in women treated by SCP than in women treated by vaginal procedures (3% [3/99] compared with 12% [12/100], RR 3.43; 95% CI 1.10 to 10.66, I²=0%) in the systematic review of 3,414 women. In a comparative study included in the systematic review of 1,176 women there was a statistically significantly higher recurrence of posterior wall prolapse after LSC (17% [10/60]) than after sacrospinous ligament fixation (0/51, p<0.01).

4.6 In the systematic review and meta-analysis of 3,414 women, there was no statistically significant difference in quality of life measured by different types of questionnaires. In 1 RCT (n=110) a statistically significantly better quality of life was reported, as measured by the pelvic floor distress inventory (PFDI-20), in women treated by SCP than in women treated by vaginal procedures (mean difference 7.90; 95% CI 0.70 to 15.10). In a prospective case series of 70 women treated by RASC, 55% (22/40) would recommend the procedure to a relative or friend, 25% (10/40) would probably recommend the procedure and overall satisfaction was 10 (0=not at all successful, 10=very successful) at the median follow-up of 90 months. The average improvement in symptoms was 9 (0=much worse, 10=much better). In the prospective case series of 165 women treated by LSC, 83% (115/138) of women were 'quite satisfied', 12% (16/138) were 'satisfied enough' and 5% (7/138) were 'not satisfied'. In a prospective case series of 101 women treated by LSC, the quality-of-life score improved from 5.6 at baseline to 9.1 at 12 months and 8.3 at 60 months (measured on a visual analogue scale between 1 and 10).

4.7 In the prospective case series of 165 women, constipation rates increased from 7% (10/138) before surgery to 13% (18/138) at the end of follow-up. Obstructed defaecation increased from 1% (2/138) to 6% (8/138). Urgency was not reported by any women before surgery and it was reported in 2% (3/138) of women at 43 months. The incidence of pelvic pressure symptoms reduced from 67% (92/138) to 9% (12/138) at the end of follow-up. Similarly, the incidence of false urge to defaecate reduced from 51% (70/138) of women at baseline to 5% (7/138) at 43 months.

4.8 In a systematic review and meta-analysis of 5,954 women from 56 RCTs, in 3 RCTs reduction in postoperative dyspareunia was greater in the SCP group than in the VSC group (16% [7/45] for VSC compared with 36% [22/61] for SCP, RR 0.39; 95%CI 0.18 to 0.86).

4.9 The specialist advisers listed the key efficacy outcomes as patient satisfaction, elimination of the bulge in the vagina, and bladder, bowel and sexual function changes.

4.10 Fourteen commentaries from women who had experience of this procedure were received, which were discussed by the committee.