An observational study in Pelvic-floor Disorders, sponsored by Swansea University. Enrolling by invitation at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by Swansea University · Observational
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.
Approximately 700 women with pelvic-floor muscle dysfunction (PFMD), consecutively referred to the Women's Health Unit at Singleton Hospital, Swansea, will be given full information about the study at their initial referral at Singleton Hospital, and asked if they would 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 The participants will ask completed questionnaires around patient-reported measures of their pelvic-function (Queensland), general health (SF-12) quality of life (EQ-5D), and psychological state (HADS; PVQ-II; ACEs; LSI; WPAQ) questionnaires. The should take about 30 minutes to complete. Patients will then have their Women's Health Physiotherapy treatment, as usual, which will not be impacted this research. At discharge, the same data as described above will be obtained. A randomly selected subset of patients (N=80) will be contacted following their initial appointment. Half of these will have attended, and half will not have attended their interview. Following them giving their informed consent to a telephone interview, they will participate in a semi-structured interview concerning their thoughts on the healthcare offered, and reasons they did/did not attend. This interview will last 15-30 minutes, depending on the participant, be conducted by a researcher who is not a member of their healthcare team, recorded anonymously, and analysed.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's planned enrollment of 700 is above the median of 161 across 60 observational studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Swansea University is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women over 18 years of age with pelvic-floor disorders
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with pelvic-floor muscle dysfunction undergoing women's health physiotherapy
Other: Women's health physiotherapy
Women's health physiotherapy for pelvic-floor dysfunction
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.
Time frame: 5 years
Plan to share: No — No sharing will be needed outside the research team.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Apr 2030, 60 months after the start.
Of 26 observational studies under Pelvic Floor Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's planned 60 months is above that.
How these figures are worked out, and which studies are left out of them.
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Swansea University