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 A non-randomised study, included in a systematic review of 311 women with uterine prolapse, compared 36 women treated by mesh sacrohysteropexy with 39 women treated by hysterectomy with concomitant sacrocolpopexy. There was no objective failure (defined as prolapse at less than 6 cm above the hymen) in either group. This was at a mean follow‑up of 51 months.

4.2 In the same non-randomised study included in the systematic review of 311 women, none of the 75 women needed a further operation for recurrent or de novo prolapse at a mean follow‑up of 51 months. In a prospective case series of 67 women treated by sacrocolpopexy with concomitant total abdominal hysterectomy, recurrent stage 2 rectocele without any cystoceles or vault prolapse occurred in 8% (4/64) of women at a median follow‑up of 27 months. A retrospective comparative study of 182 women with uterovaginal prolapse compared 123 women treated by total vaginal hysterectomy with concomitant laparoscopic sacrocolpopexy (TVH+LSC) with 59 women treated by laparoscopic supracervical hysterectomy with concomitant laparoscopic sacrocolpopexy (LSCH+LSC). There was no difference in anatomical success (defined as no prolapse at or beyond the hymen and no apical prolapse beyond the mid-vagina; TVH+LSC 94% versus LSCH+LSC 93%, p=0.8) or subjective success (defined as the absence of bulge symptoms and overall Patient Global Impression of Improvement‑I response of 'very much better' or 'much better'; TVH+LSC 91% versus LSCH+LSC 81%, p=0.3) between the 2 groups.

4.3 In the prospective case series of 67 women treated by sacrocolpopexy with concomitant total abdominal hysterectomy, 93% (60/64) of women reported satisfaction with the procedure at a median follow‑up of 27 months. Mean pelvic floor distress inventory scores improved from 50 to 10 (p=0.001).

4.4 The specialist advisers considered key efficacy outcomes as patient satisfaction, correction of prolapse and reduction of a bulge.

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

  • National Institute for Health and Care Excellence (NICE)