Apical pelvic organ prolapse Urological and Genital Diseases
Conditions
Interventions
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
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed