NCT06961513

Patient Evaluation of Treatment of Pelvic-floor Muscle Dysfunction.

Not yet recruiting Last updated 9 May 2025

What this trial tests

trial testing Women's health physiotherapy in Pelvic-floor Disorders in 700 participants. Not yet recruiting.

Timeline

29 April 2025

Primary endpoint
30 April 2030

30 April 2030

Quick facts

Lead sponsor	Swansea University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	700
Start date	29 April 2025
Primary completion	30 April 2030
Estimated completion	30 April 2030
Sites	1 location across United Kingdom

Drugs / interventions tested

• Women's health physiotherapy

Conditions studied

• Pelvic-floor Disorders — all drugs for Pelvic-floor Disorders →

Sponsor

Swansea University

Who can join

18 and older, female only, with Pelvic-floor Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 to a telephone interview concerning their thoughts on the healthcare offered, and reasons they did/did not attend. This interview will be conducted, recorded anonymously, and analysed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.