Infracoccygeal sacropexy using mesh to repair vaginal vault prolapse

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 vaginal vault or uterine prolapse in 7,054 patients (which included 976 patients treated by 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 vaginal vault prolapse only, recurrent prolapse at the original site was 7% (4/60 patients). In a case series of 118 patients with vaginal vault or uterine prolapse, the reoperation rate for recurrent prolapse was 2% (2/118) of patients after a mean follow-up of 59 months. In a case series of 577 patients, 4% (20/496) of patients had another operation for recurrent prolapse within 10 to 96 weeks.

4.2 In a systematic review of 2,653 patients with vaginal vault or uterine prolapse (655 patients treated by infracoccygeal sacropexy), the mean objective success rate was 88% (range 37 to 99%; 95% confidence interval [CI] 87.2 to 89.1). In a randomised controlled trial (RCT) of 49 patients with vaginal vault or uterine prolapse treated by infracoccygeal sacropexy or sacrospinous suspension, anatomical success rates were 95% (20/21) and 100% (24/24) respectively (p=0.94) after a mean follow-up of 17 months. In a case series of 44 patients with vaginal vault or uterine prolapse, the success rate was 93% (41/44 patients) at 9-year follow-up. In the case series of 577 patients, anatomical results at median 7-week follow-up were assessed as good or excellent in 88% of patients (436/496); functional results were assessed as good or excellent in 83% (412/496) of patients.

4.3 In the RCT of 49 patients treated by infracoccygeal sacropexy or sacrospinous suspension, postoperative rates of urinary stress incontinence were 0% (0/21) and 8% (2/24) respectively, compared with preoperative rates of 52% (11/21) and 29% (7/24) respectively. Postoperative rates of urgency were 14% (3/21) and 25% (6/24) respectively, compared with preoperative rates of 52% (11/21) and 50% (12/24) respectively. The differences between the treatment groups were not statistically significant. In the case series of 118 patients, persistent urinary stress incontinence, urge incontinence and bladder overactivity symptoms were reported in 3% (3/118), 3% (4/118) and 4% (5/118) of patients respectively, after a mean follow-up of 59 months. In the case series of 44 patients, none of the 18 patients who had nocturia at baseline and none of the 12 patients who had urgency at baseline reported these at 9-year follow-up (p=0.003 and 0.04 respectively).

4.4 In the RCT of 49 patients, quality-of-life scores improved similarly in both treatment groups; the only statistically significant difference was for the Pelvic Organ Prolapse Distress Inventory score, which improved by 50% or more in 75% of patients treated by infracoccygeal sacropexy compared with 65% for sacrospinous suspension (p=0.02). In the case series of 118 patients, the Urinary Impact questionnaire scores improved from 134.6 at baseline to 115.7 after surgery (p<0.05) and the Pelvic Organ Prolapse Impact questionnaire scores improved from 164.3 at baseline to 108.4 after surgery (p<0.05), at a mean follow-up of 59 months.

4.5 In the RCT of 49 patients treated by infracoccygeal sacropexy or sacrospinous suspension, 86% and 79% of patients respectively were satisfied or very satisfied after the procedure (p=0.85). In the case series of 44 patients, all patients noted that their quality of life had improved and they would recommend the surgery to their friends.

4.6 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.

4.7 Thirteen commentaries from patients who had experience of this procedure were received, which were discussed by the committee.