Patient evaluation of treatment of pelvic-floor muscle dysfunction
Research type
Research Study
Full title
Patient-reported outcomes and views of treatments for pelvic-floor muscle dysfunction, and their relationship to patient psycho-social characteristics.
IRAS ID
354349
Contact name
Phil Reed
Contact email
Sponsor organisation
Swansea University
Clinicaltrials.gov Identifier
x, x
Duration of Study in the UK
5 years, 0 months, 31 days
Research summary
Pelvic-floor muscle dysfunction (PFMD) affects 25% of women. It involves urinary and faecal incontinence, prolapse, sexual dysfunction, pelvic pain, and is associated with psycho-social issues (depression, anxiety), impacting negatively quality-of-life. First-line treatment for PFMD is women’s health physiotherapy, which is safe, patient acceptable, and clinically effective. However, its effectiveness can be compromised by patient nonattendance/nonengagement, which can result in worsening of condition necessitating later surgery. The current research assesses factors contributing to outcomes, and nonattendance/nonengagement, so this knowledge may help improve healthcare system support and delivery.
A range of routinely-collected factors at intake (physical functioning, psychological functioning, and demographic-social characteristics) will be related to routinely-gathered outcomes (patient-rated improvement in function; attendance and engagement). Additionally, a subset of patients who either attended or did not attend appointments, will be interviewed about their reasons for attendance/nonattendance. The aims are to determine: (1) whether any patient factors predict outcomes (functioning, attendance/engagement); (2) whether clusters of intake-factors differentiate patients who did/did not attended; and (3) patient views on why they attended or did not.
Consecutively referred women with PFMD at the Women’s Health Unit, Singleton Hospital, Swansea, will be asked for informed consent to participate. Following consent, routine assessment height, weight, age, diagnosis any physical measures of pelvic floor functioning will be taken, collected by medical staff. Questionnaires on patient-reported measures of pelvic-function, general health, quality of life, and psychological state will be completed, which should take 30min to complete. Patients will then have physiotherapy treatment, as usual. At discharge, the same data will be obtained. A subset of patients (N=80) will be contacted following initial appointment; half who attended, and half who did not. Following their consent, a telephone interview concerning their thoughts on the healthcare offered, and reasons they did/did not attend, will be conducted. This interview will be conducted, recorded anonymously, and analysed.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
25/NW/0095
Date of REC Opinion
17 Apr 2025
REC opinion
Further Information Favourable Opinion