Exploring the views of women and healthcare professionals on whether we can run a future study comparing two types of surgery for pelvic organ prolapse
| ISRCTN | ISRCTN12229381 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12229381 |
| IRAS number | 317621 |
| Secondary identifying numbers | RG 22-160, NIHR151938, IRAS 317621, CPMS 53282 |
- Submission date
- 31/08/2023
- Registration date
- 16/10/2023
- Last edited
- 05/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Many women, of all ages, experience pelvic floor disorders, which can cause lots of problems including worry and embarrassment. When the pelvic floor muscles work well, they hold the bladder, bowel, and vagina in the right position. When the muscles don’t work well, a woman’s organs can bulge or hang down into the vagina – this is called pelvic organ prolapse. 1 in 2 women experience pelvic organ prolapse in their lifetime. When the womb or neck of the womb hang into the vagina, this is called apical pelvic organ prolapse.
Women with apical pelvic organ prolapse can choose to do nothing, have a non-surgical vaginal support pessary, or have one of two different operations to help with their symptoms. Colpocleisis is an operation that pushes the apical pelvic organ prolapse back into the pelvis by closing or partially closing the vagina. Sacrospinous fixation is an operation where the top of the vagina is stitched to a ligament in the pelvis. Colpocleisis is a simpler surgery compared to sacrospinous fixation, and women are less likely to need further surgery. But having colpocleisis means that a woman can no longer have vaginal intercourse although they can engage in other types of intimacy. Some women might not be able to have sex even if they wanted to because of their bulge symptoms and so surgery might help them. There are important things for women and their healthcare professionals to consider when making treatment decisions.
Currently, we don’t have strong evidence on which of the two operations is better. We don’t know if women with apical pelvic organ prolapse, and healthcare professionals would accept a study comparing the two operations. This research (called the C-POP study) will explore if it is possible to do such a comparison study.
Who can participate?
1. Adult women (or those assigned female at birth), who have been diagnosed with apical pelvic organ prolapse, are eligible for both colpocleisis and sacrospinous fixation operations (or have already had one or both surgeries previously), able to provide consent to take part, and can speak English, Polish, Urdu, Punjabi or Welsh.
2. Adult healthcare professionals who work in UK complex uro-gynaecology centres who are involved in the care of women with apical pelvic organ prolapse (either currently or within the last 5 years), able to provide consent to take part and can speak English.
3. Adult stakeholders including (but not limited to) women diagnosed with apical pelvic organ prolapse, health and social care professionals, policymakers, health economists, commissioners, representatives from third sector organisations (e.g., charities and advocacy groups) in the UK, able to consent to take part and can speak English.
What does the study involve?
We have designed a programme of research to explore if it is possible to undertake a study comparing the operations for apical pelvic organ prolapse. This research will include (1) discussions with about 60 women with apical pelvic organ prolapse who are eligible for an operation or have had the relevant surgery, and (2) discussions with about 30 healthcare professionals who care for women with apical pelvic organise prolapse, to understand their treatment decisions and preferences and why.
Women and clinicians will be identified from across the UK to ensure that we hear from those with different views and experiences. We will also ask clinicians to make a note of the number of women with apical pelvic organ prolapse that they see in their clinics over a six-month period. It is important to see how many women we might be able to recruit to the comparative study of the operations. Towards the end of C-POP, we will run a workshop with women, health and social care professionals, and other interested parties to talk about what we have found out and where we might go next with a comparison study.
What are the possible benefits and risks of participating?
We do not know whether women or healthcare professionals will benefit personally from taking part in this study, but the knowledge gained will inform future studies and treatment. This might lead to improved treatment options for women who have apical pelvic organ prolapse. Some people also appreciate an opportunity to talk about their experiences with somebody who is there to listen.
Taking part does not involve any treatments or tests, so there are no physical risks involved. However, the researchers recognise the sensitive nature of the topic and that women may find it difficult to talk about their experiences and healthcare professionals may also find talking about some experiences difficult or upsetting. If participants do experience discomfort at any point, their interviews can be paused or rescheduled or stopped altogether. Participants who become distressed will be signposted to support services if needed.
Where is the study run from?
Institute of Applied Health Research, University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
April 2023 to December 2024
Who is funding this study?
The National Institute for Health and Care Research (UK)
Who is the main contact?
Dr Laura Jones, L.L.Jones@bham.ac.uk
Contact information
Principal Investigator
Murray Learning Centre
Institute of Applied Health Research
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-4018-3855 |
|---|---|
| Phone | +44 (0)121 414 3024 |
| L.L.Jones@bham.ac.uk |
Study information
| Study design | Qualitative research; quantitative cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community, Home, Hospital, Medical and other records, University/medical school/dental school |
| Study type | Other, Screening, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Exploring the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women with pelvic organ prolapse (the C-POP study) |
| Study acronym | C-POP |
| Study hypothesis | The overall aim of the study is to explore the feasibility and acceptability of conducting a study comparing the effectiveness of colpocleisis with sacrospinous fixation in women with apical pelvic organ prolapse. This aim will be addressed via five objectives and delivered via four work packages (WP1-4). |
| Ethics approval(s) |
1. Approved 27/10/2023, North West - Preston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)207 104 8364; +44 (0)207 104 8156; +44 (0)207 104 8181; preston.rec@hra.nhs.uk), ref: 23/NW/0288 2. Approved 01/11/2023, Health Research Authority (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; preston.rec@hra.nhs.uk), ref: 23/NW/0288 |
| Condition | Apical pelvic organ prolapse |
| Intervention | WP1: Qualitative interviews (women/people assigned female at birth with apical pelvic organ prolapse) WP2: Qualitative interviews (with healthcare professionals caring for patients with apical pelvic organ prolapse) WP3: Quantitative data collection of numbers of patients seen in a 6-month period in clinic who may be eligible for a potential future trial WP4: Qualitative workshop/discussion group with stakeholders who might be involved in a future trial |
| Intervention type | Other |
| Primary outcome measure | 1. An understanding of whether women with apical pelvic organ prolapse, the healthcare professionals who care for them, and other key stakeholders think that a future clinical trial comparing colpocleisis with sacrospinous fixation is feasible and acceptable. Data will be primarily qualitative (apart from a non-validated demographic questionnaire that will allow us to describe the sample of participants) in nature including audio files, transcripts, and field notes. Participants in WP1 and WP2 will take part in a one-off interview lasting approximately 60 minutes. Data will be collected and analysed over a 17-month period. Participants in WP4 will take part in a one-off 3-hour workshop. Data will be collected and analysed over a 7-month period. Interviews and discussion workshops will be audio-recorded and transcribed. Qualitative data will be analysed using a reflexive thematic analysis approach. |
| Secondary outcome measures | 1. A quantitative assessment of the number of potential women who would be eligible for a future effectiveness trial. Local participating sites (an anticipated eight sites across England, Wales and Scotland) will collect anonymised data (e.g., age, ethnicity, the first part of the woman’s postcode, and first language) on women meeting the eligibility criteria via scrutiny of referral letters and clinic notes. Anonymised data will be reported at least once a month for a total of 6 months. Data will be analysed descriptively and modelled to estimate the number of women across the UK likely to be eligible for recruitment into a future effectiveness trial. 2. A final programme theory providing clear guidance, informed by novel insight from women, healthcare professionals, and diverse stakeholders, on the feasibility of and key considerations for a future effectiveness trial. Aligned with the 2021 MRC/NIHR framework for Developing and Evaluating Complex Interventions data will be primarily qualitative (WP1, 2, 4) with additional quantitative cross-sectional information (WP3). Data will be collected and analysed over 17 months. Data will be analysed using reflexive thematic analysis (qualitative) and descriptive statistics (quantitative). |
| Overall study start date | 01/04/2023 |
| Overall study end date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer, Service user, Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | WP1: 50-60 women; WP2: 20-30 healthcare professionals; WP4: Up to 30 stakeholders |
| Total final enrolment | 99 |
| Participant inclusion criteria | WP1: 1. Female (or assigned female at birth) 2. Age 18 years and above 3. Diagnosed with apical pelvic organ prolapse 4. Eligible for both colpocleisis and SSF procedures (or have already had one or both surgeries previously) 5. Ability to provide informed consent 6. Able to communicate in either English, Polish, Urdu, Punjabi or Welsh WP2: 1. UK-based secondary care healthcare professionals involved in the care of women with apical pelvic organ prolapse (either currently or within the last 5 years) 2. Working in a UK complex uro-gynaecology centre 3. Able to give informed consent and speak English WP3: 1. Females (or those assigned female at birth) 2. Age 18 years and above 3. Diagnosed with apical pelvic organ prolapse 4. Eligible for both colpocleisis and SSF procedures (i.e., no longer intend to have penetrative vaginal intercourse and who are willing to have either surgical procedure) WP4: 1. Women as per WP1 2. Healthcare professionals as per WP2 3. Other stakeholders who might be involved in a future effectiveness trial, can converse in English, and who can give informed consent |
| Participant exclusion criteria | WP1: There are no exclusion criteria WP2: HCPs based in primary care WP3: There are no exclusion criteria WP4: There are no exclusion criteria |
| Recruitment start date | 01/11/2023 |
| Recruitment end date | 05/12/2024 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Institute of Applied Health Research
Birmingham
B15 2TT
United Kingdom
Cowcaddens Road
Glasgow
G4 0BA
United Kingdom
St Luke's Campus
Heavitree Road
Exeter
EX1 2LU
United Kingdom
Birmingham
B4 6NH
United Kingdom
SA11 3LX
United Kingdom
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Southmead Road
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Jessop Wing
Herries Road
Sheffield
S5 7AU
United Kingdom
Shrewsbury
SY3 8XQ
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Lewisham High Street
London
SE13 6LH
United Kingdom
Sponsor information
University/education
Research Strategy and Services Central
Birmingham Research Park
University of Birmingham
97 Vincent Road
Edgbaston
Birmingham
B15 2SQ
England
United Kingdom
| Phone | +44 (0)7814 650003 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
| Website | http://www.birmingham.ac.uk/index.aspx |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 05/03/2025: Contractual agreement with the funder to publish a paper reporting the programme theory. Up to four additional papers may be written including (1) women's experiences, (2) healthcare professionals' experiences, (3) quantitative (audit) data (4) reporting of the Patient Advisory Group and Patient Public Involvement and Engagement. There is no longer (as of February 2025) a requirement for publication via the anticipated NIHR threaded publication and synthesis pathway. Dissemination Our dissemination strategy has been informed by NIHR’s dissemination and impact guidance. We have identified a range of audiences to target for dissemination and impact. These include women with apical pelvic organ prolapse, people who care for women with apical pelvic organ prolapse, the public, commissioning organisations (e.g., integrated care systems, NHS England, Royal College of Obstetricians and Gynaecologists (RCOG)), healthcare and social care professionals involved in UG service provision, external statutory organisations (e.g., Department for Health and Social Care, NICE, NHS Information Centres, The British Society of Urogynaecology (BSUG)), and other organisations (e.g., Bladder Health UK, liveUTIfree). Our dissemination strategy will target the breadth of these audiences. Our strategy will be developed using evidence for translating knowledge into practice, for example, the Scientist Knowledge Translation Plan and the NIHR dissemination and impact guidance. We will prioritise early dissemination using a proactive strategy to maximise the likelihood of reaching key audiences and furthering public and academic knowledge around surgical interventions for AP. Although all members of the project team will have a role in dissemination, several members of our team will be able to act as dissemination champions (i.e., study coordinator, Chief Investigator, PPIE leads, and practising clinicians. We will use various methods to inform stakeholders of our work, including: Early stage and ongoing methods: blogs, social media outputs, infographics aimed at different audiences and ongoing networking with stakeholders such as BSUG etc End of study methods: published articles, NIHR report (threaded publication), conference presentations (e.g., International Continence Society Conference; IUGA Annual meeting, UKSBM BSUG scientific update), press release of study findings, end of study video summary. To ensure that dissemination is not solely passive, we will include active strategies. For example, we are fortunate that our co-applicant patient representative is the only patient advocate on the National Bladder and Bowel Project and the NHS England Excellence in Continence Care Board. Several members of the team are representatives on the All Party Parliamentary Group Bladder and Bowel Care. Further to this, we have active support from RCOG, BSUG research network and liveUTIfree via their Women’s Voices Involvement Panels and contacts with practising clinicians to support dissemination activities. As a team, and with our wider networks, we are therefore in a unique position to disseminate the emerging and final recommendations, and activity discuss them, with these key groups Previous publication and dissemination plan: Publication plan (NIHR Threaded Publication and Synopsis Pathway) Three anticipated published outputs from the study will likely include: 1. Study protocol 2. Final study findings related to the research question 3. Outputs and reporting of the Patient Advisory Group and Patient Public Involvement and Engagement Dissemination Our dissemination strategy has been informed by NIHR’s dissemination and impact guidance. We have identified a range of audiences to target for dissemination and impact. These include women with apical pelvic organ prolapse, people who care for women with apical pelvic organ prolapse, the public, commissioning organisations (e.g., integrated care systems, NHS England, Royal College of Obstetricians and Gynaecologists (RCOG)), healthcare and social care professionals involved in UG service provision, external statutory organisations (e.g., Department for Health and Social Care, NICE, NHS Information Centres, The British Society of Urogynaecology (BSUG)), and other organisations (e.g., Bladder Health UK, liveUTIfree). Our dissemination strategy will target the breadth of these audiences. Our strategy will be developed using evidence for translating knowledge into practice, for example, the Scientist Knowledge Translation Plan and the NIHR dissemination and impact guidance. We will prioritise early dissemination using a proactive strategy to maximise the likelihood of reaching key audiences and furthering public and academic knowledge around surgical interventions for AP. Although all members of the project team will have a role in dissemination, several members of our team will be able to act as dissemination champions (i.e., study coordinator, Chief Investigator, PPIE leads, and practising clinicians. We will use various methods to inform stakeholders of our work, including: Early stage and ongoing methods: blogs, social media outputs, infographics aimed at different audiences and ongoing networking with stakeholders such as BSUG etc End of study methods: published articles, NIHR report (threaded publication), conference presentations (e.g., International Continence Society Conference; IUGA Annual meeting, BSUG scientific update), press release of study findings, end of study video summary. To ensure that dissemination is not solely passive, we will include active strategies. For example, we are fortunate that our co-applicant patient representative is the only patient advocate on the National Bladder and Bowel Project and the NHS England Excellence in Continence Care Board. Several members of the team are representatives on the All Party Parliamentary Group Bladder and Bowel Care. Further to this, we have active support from RCOG, BSUG research network and liveUTIfree via their Women’s Voices Involvement Panels and contacts with practising clinicians to support dissemination activities. As a team, and with our wider networks, we are therefore in a unique position to disseminate the emerging and final recommendations, and activity discuss them, with these key groups. |
| IPD sharing plan | Only the research team, the Sponsor, relevant regulatory authorities, and the funder will have access to the final study dataset that will comprise demographic questionnaires, audio recordings and transcripts of interviews and stakeholder events, and an anonymised database of potentially eligible women for a future trial. After publication of the main findings of the study, the research team will consider external requests to gain access to anonymised data, to be securely shared under the auspices of the Chief Investigator (Dr Laura Jones; L.L.Jones@bham.ac.uk). The dataset will be preserved and available for this purpose for a minimum of 10 years following the end of the study. All requestors wishing to obtain study data will be asked to provide a brief research proposal including the objectives and timelines of the candidate project, intellectual property rights, and expectations for publications and citations. These details will form the basis of a Data Sharing Agreement between the University of Birmingham and the requestor, to clearly establish the responsibilities of each party. It is expected that requestors will, as a minimum, acknowledge the original research team and NIHR funding, and will consider co-authorship of any subsequent publications, if appropriate. Permission for anonymised data to be shared for the purpose of future academic research will be sought from all participants via the informed consent form. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 6.0 | 20/10/2023 | 03/11/2023 | No | No |
| Protocol file | version 7.1 | 08/03/2024 | 04/06/2024 | No | No |
Additional files
Editorial Notes
05/03/2025: The following changes were made to the study record:
1. Publication and dissemination plan updated.
2. The recruitment end date was changed from 30/11/2024 to 05/12/2024.
3. Total final enrolment added.
04/06/2024: Uploaded protocol (not peer-reviewed). The study participating centres were updated to add Norfolk & Norwich University Hospital, South Tees Hospitals NHS Foundation Trust, Lewisham and Greenwich NHS Trust.
03/11/2023: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed).
2. The ethics approval was added.
02/11/2023: Internal review.
17/10/2023: The recruitment start date was changed from 01/10/2023 to 01/11/2023.
01/09/2023: Study's existence confirmed by the NIHR.
