Cambridge-PROMPT study
Research type
Research Study
Full title
The Cambridge-PROMPT study: Cambridge Patient Reported Outcome Measure for patients under Pelvic mesh Treatment
IRAS ID
308860
Contact name
Nikesh Thiruchelvam
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In pelvic mesh surgery, a sheet of material is permanently implanted to support pelvic organs that have shifted downwards into the vagina, or to treat the involuntary leaking of urine. Research suggests up to 30% of women experience long-lasting pelvic pain after pelvic mesh surgery. However, the current tools used to assess pain related to pelvic mesh implants have not been developed specifically for these patients.
To address this issue, the aim of this project is to develop a questionnaire that can be used to assess pain associated with pelvic mesh implants.
We will hold a series of three focus groups with patients who currently experience pain associated with a pelvic mesh implant. We will also hold three focus groups with health professionals with experience of assessing pelvic mesh outcomes. These steps will help us to define the ways that
pain associated with pelvic mesh implants is different from other types of pain.We will then develop a series of questions that could be used to assess mesh-related pain. These questions will be reviewed by panels of 15 pelvic mesh patients and 15 experts, and the questionnaire items will be adjusted based on feedback from the panels.
The quality of the final questionnaire will be assessed in a sample of 150-200 women with symptoms related to a pelvic mesh implant. We will assess whether the questionnaire picks up changes in patient’s pain ratings over time; compare questionnaire scores with other relevant questionnaires; and compare questionnaire scores across groups of patients with and without mesh-specific pain.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0133
Date of REC Opinion
23 Jun 2022
REC opinion
Further Information Favourable Opinion