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21/581 Colpocleisis for the treatment of pelvic organ prolapse in women commissioning brief

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

In women with pelvic organ prolapse is it feasible to conduct a study comparing the effectiveness of colpocleisis with sacrospinous fixation?

  1. Intervention: Colpocleisis (vaginal obliterative surgery).
  2. Patient groups: Women with apical pelvic organ prolapse who require surgical management.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Secondary care.
  4. Comparator: Sacrospinous fixation (with or without associated procedures).
  5. Study design: A stand-alone study to assess the feasibility of whether a trial is possible and to establish key elements of the potential future trial design. This should include qualitative work with eligible women and clinicians to understand the decisions and uncertainties of those involved and the role of surgery compared to alternative interventions. In particular, eligible women’s preferences and sensitivities towards the surgical procedures should be explored.
  6. Important outcomes and outputs: Findings from qualitative work, including determination of equipoise; numbers of women potentially eligible for recruitment; acceptability of randomisation to women and clinicians; determination of important outcomes for use in a future trial to include potential benefits and harms; feasibility of trial delivery. A randomised element is not expected as part of this commission. A decision whether to advertise for a full trial will be made at a later date once results of the feasibility report are known.

Rationale

Apical pelvic organ prolapse (POP) is when the uterus, cervix, or top of the vagina (also known as ‘vaginal vault’) bulge or hang down into the vagina. These organs are normally held in position by ligaments and muscles of the pelvic floor, but these can become weakened due to factors such as pregnancy and childbirth, obesity, and the menopause. POP can have significant negative effects on a woman’s quality of life and around one in ten women will need at least one surgical procedure for POP by the time they are 80. With an increasing older population, more women will require surgery for POP.

Several of the surgical treatment options for POP involve the use of mesh, a synthetic implant which has caused serious complications for a high number of women. This means that for the majority of patients, surgery using mesh should be avoided if possible. For older, sexually inactive women who require surgical management for apical POP, and have either had a hysterectomy (removal of the uterus) or have no preference about preserving their uterus, there are two procedures used in the NHS which do not use vaginal mesh: sacrospinous fixation (SSF) and colpocleisis.

In SSF the top of the vagina is attached to a ligament in the pelvis. However, a high proportion of women who have SSF will have a recurrence of prolapse in the future, requiring further treatment. Colpocleisis is a procedure which pushes the prolapse back into the pelvis by closing or partially closing the vagina. This procedure is performed much less frequently than SSF but there is evidence to show that it has a high success rate. However, whilst the NICE guideline (NG123) committee agreed colpocleisis is a potential surgical option, they found no evidence comparing it to other surgical techniques.

NICE and the Royal College of Obstetricians and Gynaecologists have recommended research to address this evidence gap in order to counsel women on the comparative effectiveness of colpocleisis compared to SSF. It is currently unclear whether a trial would be acceptable to women and clinicians, and if it would be possible to conduct a trial in this patient group. Therefore, a feasibility study is proposed in the first instance to address these issues.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy, please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 30 March 2022. Applications will be considered by the HTA Funding Committee at its meeting in May 2022.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk