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 for women with apical prolapse including 183 women with uterine prolapse (2 randomised controlled trials [RCTs]) comparing abdominal sacrohysteropexy (open or laparoscopic approach) with vaginal hysterectomy and vault repair/support, there was no difference in repeat prolapse surgery between the groups at 1 to 8‑year follow‑up (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.36 to 1.31, n=182, low quality evidence). In a retrospective case series of 507 women with uterine prolapse treated by laparoscopic sacrohysteropexy, 3% (14/507) of women had further apical prolapse at a median follow‑up of 12 months (range 6 to 84 months) because the mesh had stretched. Of these, 10 women had plication of mesh and 3 had cervical amputation for elongation. Ongoing uterine prolapse was reported in 2 women and treated by vaginal hysterectomy; 7% (36/507) of women had further vaginal wall repair. In a case series of 194 premenopausal women with uterine prolapse treated by pectineal ligament hysteropexy (PLH) by open or laparoscopic approach, the overall reoperation rate after PLH was 15% (29/194) at a mean follow‑up of 6.5 years; 6% (10/176) of women had grade 3 uterine prolapse recurrence (7 occurred in pregnant women after vaginal delivery; 3 in non-pregnant women, of which 1 was a tape erosion into the bladder). Twelve women developed cystocele and 7 developed cervical elongation. Laparoscopic procedures had no recurrence of prolapse over 2 years.

4.2 In the systematic review including 183 women with uterine prolapse, evidence from 1 RCT (n=82) did not show a statistically significant difference between vaginal hysterectomy with vault support and abdominal sacrohysteropexy for objective failure of anterior vaginal compartment (RR 1.04, 95% CI 0.60 to 1.82), apical compartment (RR 1.00, 95% CI 0.15 to 6.76) or posterior vaginal compartment (RR 3.07, 95% CI 0.66 to 14.35) at 1‑year follow‑up. In a non-randomised comparative study of 151 women comparing laparoscopic sacral hysteropexy (n=74) with vaginal mesh hysteropexy (n=77), there was no difference between groups in the rate of apical failure (19% [12/64] laparoscopic hysteropexy compared with 16% [9/61] vaginal mesh hysteropexy, p=0.16) or anterior failure (9% [6/65] laparoscopic hysteropexy compared with 6% [4/61] vaginal mesh hysteropexy, p=0.93) at 1‑year follow‑up.

4.3 In the systematic review including 183 women with uterine prolapse, 1 RCT reported that awareness of prolapse (defined as any positive response to questions related to awareness of prolapse or vaginal bulge) was less likely after vaginal hysterectomy than after abdominal sacrohysteropexy at 8‑year follow‑up, but this result was not statistically significant (RR 0.38, 95% CI 0.15 to 0.98, n=84, moderate quality evidence). In the case series of 507 women there was significant improvement for pelvic organ prolapse quantification point C assessment (p<0.001), with a mean change of 7.9 cm between preoperative and postoperative scores at 3‑month follow‑up; 94% (379/404) of women felt that their prolapse (assessed using 7‑point Patient Global Impression of Improvement [PGI‑I] subjective measure) was 'very much' or 'much' better and 2% (6/404) felt there was no change in symptoms. No women described their symptoms as worse. In the non-randomised comparative study of 151 women comparing laparoscopic sacral hysteropexy with vaginal mesh hysteropexy, prolapse stage was similar but laparoscopic hysteropexy was associated with increased vaginal length (p<0.001), increased perineal body length (p=0.02) and better apical support (p=0.05) at 1‑year follow‑up. Overall satisfaction (measured on PGI‑I scale) was high and 79% of women in each group rated prolapse symptoms as 'very much better' and 16% 'much better' at 1‑year follow‑up.

4.4 In a case series of 100 women with uterovaginal prolapse treated by robotic sacrohysteropexy, overall quality of life (measured using the validated urogenital distress inventory and incontinence impact questionnaires [UDI/IIQ], with scores ranging from 0 to 6) improved from a mean score of 4.5 to 5.12 (p<0.05), and overall health status (based on a visual analogue scale of 0 to 100) improved from 73% to 82% (p<0.05), 6 weeks after surgery. Postoperatively women also experienced less feelings of nervousness (p=0.01), shame (p<0.05) and frustration (p<0.05). After 5 years the positive effects of these feelings remained and quality of life and overall health status remained stable.

4.5 In the case series of 194 premenopausal women with uterine prolapse, there were 46 births (32 vaginal and 14 caesarean deliveries) in 40 women after PLH. Prolapse recurred (tape avulsed from the uterus) in 7 women after vaginal delivery and was treated by vaginal hysterectomy. There were no recurrences after caesarean deliveries.

4.6 The specialist advisers listed key efficacy outcomes as resolution of prolapse symptoms and recurrent apical prolapse.

4.7 Twenty one 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)