Patient Evaluation of Treatment of Pelvic-floor Muscle Dysfunction.

NCT06961513 | Enrolling By Invitation

• 1 other identifier: 12645
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Pelvic-floor Disorders

Keywords

Pelvic-floor disorders; patient views; Women's health physiotherapy; psychology

Outcome Measures

Primary Outcomes (1)

• Attendance at sessions and improvement in pelvic-floor function.

  Attendance at scheduled sessions will be recorded, as will change in routinely collected pelvic floor functioning data.

  5 years

Study Arms (1)

Women with pelvic-floor muscle dysfunction

Women with pelvic-floor muscle dysfunction undergoing women's health physiotherapy

Other: Women's health physiotherapy

Interventions

Women's health physiotherapy OTHER

Women's health physiotherapy for pelvic-floor dysfunction

Women with pelvic-floor muscle dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women over 18 years of age with pelvic-floor disorders

You may qualify if:

• Females
• Over 18 years old
• Diagnosed with pelvic floor muscle dysfunction
• Patients referred for physiotherapy treatment at the Women's Health Unit of Singleton Hospital, Swansea

You may not qualify if:

• Patients under 18
• Patients who don't have PFMD
• Patients unable to give informed consent

Sponsors & Collaborators

• Swansea University: lead

Study Sites (1)

Singleton Hospital

Swansea, SA2 5QA, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: April 29, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)