C-POP
Research type
Research Study
Full 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)
IRAS ID
317621
Contact name
Laura Jones
Contact email
Clinicaltrials.gov Identifier
RG_22-160, Sponsor Number
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
When 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 apical-pelvic organ prolapse or A-POP. One in two women experience A-POP in their lifetime. Colpocleisis is an operation which closes or partially closes the vagina. Sacrospinous fixation (SSF) is an operation where the top of the vagina is stitched to a ligament in the pelvis. Currently, there is no strong evidence on which operation is better. Colpocleisis is simpler, but afterwards a woman cannot have vaginal intercourse, although they can engage in other types of intimacy. Some women might be unable to have sex because of their symptoms so surgery might help them. We need to better understand what is important to women to guide whether we should undertake a comparison study.
The C-POP Study aims to explore the feasibility of a study comparing surgical options for POP. We will talk to women who are eligible for or have had surgery and clinicians who care for them, to understand treatment decisions and preferences. Women and clinicians will be identified from across the UK, including from local community groups, national women’s voices groups and charities to ensure we listen to diverse voices and experiences. Clinicians will be asked to record how many women they see in clinics over 6-months to see how many women could be recruited into a future study. Through an end-of-study workshop we will share our findings and discuss a future comparison study with women, clinicians, and other interested parties. Our patient advisory group (PAG) helped us design this study and will be kept up to date, and continue to support the study via presentations, posters, videos, and written reports.
REC name
North West - Preston Research Ethics Committee
REC reference
23/NW/0288
Date of REC Opinion
3 Oct 2023
REC opinion
Favourable Opinion