4 Efficacy

4 Efficacy

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 of surgery using mesh for uterine or vaginal vault prolapse in 7,054 patients (which included 976 patients who had infracoccygeal sacropexy), the results after a median follow‑up of 13 months were as follows: prolapse recurrence rate 5% (range 0 to 25%, n=402), rate of patient-reported persistent symptoms 9% (range 2 to 21%, n=262), and reoperation rate 8% (range 0 to 30%, n=288). For uterine prolapse only, prolapse recurrence rates were 1% (1/79 of patients, 1 non-randomised comparative study) and 10% (1/10 of patients, 1 case series). In a systematic review of 3,093 patients with uterine prolapse (which included 143 patients who had infracoccygeal sacropexy), the reoperation rate for prolapse recurrence was 3% within 6 to 30 months after the procedure.

4.2 In a randomised controlled trial (RCT) of 49 patients with uterine or vaginal vault prolapse who had infracoccygeal sacropexy or sacrospinous suspension, postoperative rates of stress urinary incontinence or urgency and quality-of-life scores were not statistically significantly different between the treatment groups after a mean follow‑up of 17 months. The only statistically significant difference was for the Pelvic Organ Prolapse Distress Inventory score, which improved by 50% or more in 75% of patients who had infracoccygeal sacropexy compared with 65% for sacrospinous suspension (p=0.02).

4.3 In the systematic review of 3,093 patients, the anatomical cure rates for apical support ranged from 90% to 97%.

4.4 In the RCT of 49 patients who had infracoccygeal sacropexy or sacrospinous suspension, 86% and 79% of patients respectively were satisfied or very satisfied after the procedure.

4.5 The specialist advisers listed the key efficacy outcomes as: patient satisfaction and comfort, quality of life, change in urinary, bowel and sexual function, objective prolapse assessment and long-term prolapse recurrence risk.

  • National Institute for Health and Care Excellence (NICE)