Surgical interventions for uterine prolapse and for vault prolapse: the two VUE RCTs.

BACKGROUND

New surgical approaches for apical prolapse have gradually been introduced, with few prospective randomised controlled trial data to evaluate their safety and efficacy compared with traditional methods.

OBJECTIVE

To compare surgical uterine preservation with vaginal hysterectomy in women with uterine prolapse and abdominal procedures with vaginal procedures in women with vault prolapse in terms of clinical effectiveness, adverse events, quality of life and cost-effectiveness.

DESIGN

Two parallel randomised controlled trials (i.e. Uterine and Vault). Allocation was by remote web-based randomisation (1 : 1 ratio), minimised on the need for concomitant anterior and/or posterior procedure, concomitant incontinence procedure, age and surgeon.

SETTING

UK hospitals.

PARTICIPANTS

Uterine trial - 563 out of 565 randomised women had uterine prolapse surgery. Vault trial - 208 out of 209 randomised women had vault prolapse surgery.

INTERVENTIONS

Uterine trial - uterine preservation or vaginal hysterectomy. Vault trial - abdominal or vaginal vault suspension.

MAIN OUTCOME MEASURES

The primary outcome measures were women's prolapse symptoms (as measured using the Pelvic Organ Prolapse Symptom Score), prolapse-specific quality of life and cost-effectiveness (as assessed by incremental cost per quality-adjusted life-year).

RESULTS

Uterine trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for uterine preservation was 4.2 (standard deviation 4.9) versus vaginal hysterectomy with a Pelvic Organ Prolapse Symptom Score of 4.2 (standard deviation 5.3) (mean difference -0.05, 95% confidence interval -0.91 to 0.81). Serious adverse event rates were similar between the groups (uterine preservation 5.4% vs. vaginal hysterectomy 5.9%; risk ratio 0.82, 95% confidence interval 0.38 to 1.75). There was no difference in overall prolapse stage. Significantly more women would recommend vaginal hysterectomy to a friend (odds ratio 0.39, 95% confidence interval 0.18 to 0.83). Uterine preservation was £235 (95% confidence interval £6 to £464) more expensive than vaginal hysterectomy and generated non-significantly fewer quality-adjusted life-years (mean difference -0.004, 95% confidence interval -0.026 to 0.019). Vault trial - adjusting for baseline and minimisation covariates, the mean Pelvic Organ Prolapse Symptom Score at 12 months for an abdominal procedure was 5.6 (standard deviation 5.4) versus vaginal procedure with a Pelvic Organ Prolapse Symptom Score of 5.9 (standard deviation 5.4) (mean difference -0.61, 95% confidence interval -2.08 to 0.86). The serious adverse event rates were similar between the groups (abdominal 5.9% vs. vaginal 6.0%; risk ratio 0.97, 95% confidence interval 0.27 to 3.44). The objective anterior prolapse stage 2b or more was higher in the vaginal group than in the abdominal group (odds ratio 0.38, 95% confidence interval 0.18 to 0.79). There was no difference in the overall prolapse stage. An abdominal procedure was £570 (95% confidence interval £459 to £682) more expensive than a vaginal procedure and generated non-significantly more quality-adjusted life-years (mean difference 0.004, 95% confidence interval -0.031 to 0.041).

CONCLUSIONS

Uterine trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between uterine preservation and vaginal hysterectomy. Vault trial - in terms of efficacy, quality of life or adverse events in the short term, no difference was identified between an abdominal and a vaginal approach.

FUTURE WORK

Long-term follow-up for at least 6 years is ongoing to identify recurrence rates, need for further prolapse surgery, adverse events and cost-effectiveness.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN86784244.

FUNDING

This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in

About 1 in 10 women has pelvic organ prolapse (POP) surgery, and around three of these women require a further operation. The aim of this study was to identify the most appropriate surgery for two different types of POP found in women: (1) when the uterus itself has come down – the Uterine trial – and (2) when a previous hysterectomy has resulted in the top of the vagina coming down – the Vault trial. In the Uterine trial, preserving the uterus was compared with removing it vaginally. In the Vault trial, uplifting and supporting the vault prolapse using an abdominal approach was compared with a vaginal approach. Women were asked about their prolapse and other symptoms affecting their quality of life (QoL). The majority of women reported that their prolapse symptoms and QoL improved after surgery. The women’s prolapse was also measured by clinical examination before and 12 months after their operation. All of these results were compared between the different procedures. It was found that all the surgical procedures were successful within the 12-month review period. Abdominal surgery in the Vault trial as well as any that was required in the Uterine trial, was, however, slightly less cost-effective. Serious complications and the need for further prolapse surgery were similar in all groups. A small number of women did require additional surgery for prolapse recurrence or for small mesh exposure when additional or prolapse procedures had involved mesh. Women in both trials will be followed up for at least 6 years to determine longer-term costs and consequences.

Déclaration de conflit d'intérêts

Robert Freeman reports speaker fees [from Bard Medical (Covington, GA, USA), Astellas Pharma Inc. (Tokyo, Japan) and Pfizer Inc. (New York City, NY, USA)] and grants from the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme. John Norrie reports membership of the following NIHR boards: the Cardiopulmonary Resuscitation Decision-making Committee, HTA Commissioning Board, HTA Commissioning Sub-Board (Expression of Interest), HTA Funding Boards Policy Group, HTA General Board and HTA Post-board Funding Teleconference; the NIHR Clinical Trials Unit Standing Advisory Committee; the NIHR HTA and Efficacy and Mechanism Evaluation Editorial Board; and the Pre-exposure Prophylaxis Impact Review Panel.