Pelvic-floor DisordersNCT06961513
Patient Evaluation of Treatment of Pelvic-floor Muscle Dysfunction.
An observational study of Pelvic-floor Disorders, run by Swansea University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic-floor Disorders
- What is being tested?
- Women's health physiotherapy
- How many people
- 700 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2025to 30 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over 18 years of age with pelvic-floor disorders
Who may be able to join
- 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
Who cannot join
- Patients under 18
- Patients who don't have PFMD
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Patient-reported Outcomes and Views of Treatments for Pelvic-floor Muscle Dysfunction, and Their Relationship to Patient Psycho-social Characteristics.
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.
Read the detailed description
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.
- Conditions
- Pelvic-floor Disorders
- Being tested
- Women's health physiotherapy
- Keywords
- Pelvic-floor disorders, patient views, Women's health physiotherapy, psychology
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women's health physiotherapyOther
Women's health physiotherapy for pelvic-floor dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Women with pelvic-floor muscle dysfunction | Women with pelvic-floor muscle dysfunction undergoing women's health physiotherapy Receives: Other: Women's health physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start29 Apr 2025
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic-floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961513
- Sponsor's protocol ID
- 12645
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing will be needed outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes and Views of Treatments for Pelvic-floor Muscle Dysfunction, and Their Relationship to Patient Psycho-social Characteristics.
- ClinicalTrials.gov ID
- NCT06961513
- Acronym / sponsor ID
- 12645
- Conditions
- Pelvic-floor Disorders
- Keywords
- Pelvic-floor disorders, patient views, Women's health physiotherapy, psychology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with pelvic-floor muscle dysfunction | – | Other: Women's health physiotherapyWomen with pelvic-floor muscle dysfunction undergoing women's health physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years of age with pelvic-floor disorders
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients under 18
- Patients who don't have PFMD
- Patients unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women's health physiotherapyWomen's health physiotherapy for pelvic-floor dysfunction | Other | Women with pelvic-floor muscle dysfunction |
Primary outcome
Attendance at sessions and improvement in pelvic-floor function.
Time frame: 5 years
Attendance at scheduled sessions will be recorded, as will change in routinely collected pelvic floor functioning data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No. No sharing will be needed outside the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic-floor Disorders, run by Swansea University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance at sessions and improvement in pelvic-floor function. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.