Pelvic Prolapse ConditionsBEAM UP & GLOWNCT07310121
Barriers and Enablers to Accessing Medical Care for Urinary Incontinence and Prolapse in GLobal Majority Women
An observational study of Pelvic Prolapse Conditions, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This project aims to explore barriers to treatment seeking for symptoms of prolapse and urinary incontinence in women from ethnic minority/global majority background. This study consists of three components, each with different methodological approaches: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Prolapse Conditions
- How many people
- 160 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2025to 30 Nov 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who have been referred to MFT for the specified condition. Women attending select community centres in Greater Manchester area.
Who may be able to join
- To be willing and able to give informed consent
- To have been born female and to currently identify as female
- To be over the age of 18 years
- To have accessed medical care for urinary incontinence or pelvic organ prolapse
- To be from an ethnic minority/ global majority background
- To be able to speak and understand English
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- To be willing and able to give informed consent
- To have been born female and to currently identify as a woman
- To be over the age of 18 years
- To be from an ethnic minority/ global majority background
- To be able to speak and understand either English, or a language which the community group translator can communicate in
Who cannot join
- -
- Women attending select community centres in Greater Manchester area.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Manchester University Hospitals NHS Foundation Trust
Manchester, M13 9WL
About this study
This project aims to explore barriers to treatment seeking for symptoms of prolapse and urinary incontinence in women from ethnic minority/global majority background.
This study consists of three components, each with different methodological approaches:
- Collecting objective data using validated questionnaires Prolapse and Incontinence Knowledge Questionnaire (PIKQ), Female Genital Self-Image Scale (FGSIS-4) and prevalence and severity of urinary incontinence and pelvic organ prolapse (ICIQ-UI Short Form and ICIQ-VS), age, level of education, level of deprivation (according to postcode), faith, first or preferred language spoken, sexual orientation and employment status to explore whether these are associated with barriers to treatment seeking as measured by the Barriers to Incontinence Care Seeking Questionnaire (BICS-Q) and to estimate the prevalence of urinary incontinence and prolapse in a community group of women from an ethnic minority/global majority background
- Collecting qualitative data via semi-structured interviews with women from an ethnic minority/global majority background who have sought treatment for urinary incontinence or pelvic organ prolapse to explore barriers they may have experienced and how these were overcome and collecting qualitative data via focus group discussions with women from an ethnic minority/global majority background who attend women's community groups
- Zine making as a research approach is a creative, participatory method that uses the process of creating zines (small, self-published, often handmade booklets) to generate, explore, and share knowledge . Zine making blends arts-based research and participatory action research and is particularly suited for working with seldom heard communities or exploring stigmatised conditions because it gives participants creative control over how their experiences are communicated, which can be empowering, especially for individuals who are under or misrepresented in mainstream narratives . Zine making is also more accessible for individuals who do not speak English as their first or preferred language, or, have other communication barriers .
- Conditions
- Pelvic Prolapse Conditions
- Being tested
- No intervention
- Keywords
- Pelvic organ prolapse, Pelvic floor dysfunction, Urinary incontinence
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients with condition | Women with urinary incontinence or pelvic organ prolapse from an ethnic minority/global majority background who are attending a urogynaecology clinic in the Warrell Unit at Manchester University NHS Foundation Trust. Receives: Other: No intervention | |
| Public | Women from ethnic minority/global majority background attending community groups in Greater Manchester. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
- 24 statements, with three responses: "Agree," "Disagree," or "I don't know". Each correct answer is scored 1, incorrect or not known answers score as a 0. Total score is calculated by adding each score together with a maximum total of 24.
- The higher the score the greater the knowledge of prolapse and incontinence.
Measured: 12 months
Barriers to Incontinence Care Seeking questionnaire (BICS-Q)
- BICS-Q consists of 14 questions that address different barriers to incontinence care seeking.
- Each question is scored between 0-3 based on level of agreement with the statement.
- BICS-Q is scored on a scale of 0 to 42.
- The higher the score the more barriers to care seeking.
Measured: 12 months
Secondary outcomes (3)
International Consultation on Incontinence Questionnaire (ICIQ UI Short Form)
- ICIQ-UI SF is scored on a scale of 0 to 21.
- The higher the score the more severe the urinary incontinence.
Measured: 12 months
International Consultation on Incontinence Questionnaire and Vaginal Symptoms (ICIQ VS)
- ICIQ-VS is scored on a scale of 0 to 53.
- The higher the score the more severe the vaginal symptoms.
Measured: 12 months
Female Genital Self-Image Scale (FGSIS-4)
- FGSIS-4 is scored on a scale of 4-16.
- The higher the score the greater the female genital self-image.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study startDec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Prolapse ConditionsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Burdett Trust for Nursing
- Responsible party
- Sponsor
- Investigators
- Lucy Dwyer, PhD, Principal investigator, Manchester University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310121
- Sponsor's protocol ID
- B02637
- Other IDs
- 25/WA/0334
- Acronym
- BEAM UP & GLOW
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Enablers to Accessing Medical Care for Urinary Incontinence and Prolapse in GLobal Majority Women
- ClinicalTrials.gov ID
- NCT07310121
- Acronym / sponsor ID
- BEAM UP & GLOW / B02637
- Conditions
- Pelvic Prolapse Conditions
- Keywords
- Pelvic organ prolapse, Pelvic floor dysfunction, Urinary incontinence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Burdett Trust for Nursing
- Study start
- Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Dec 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.
This project aims to explore barriers to treatment seeking for symptoms of prolapse and urinary incontinence in women from ethnic minority/global majority background.
This study consists of three components, each with different methodological approaches:
- Collecting objective data using validated questionnaires Prolapse and Incontinence Knowledge Questionnaire (PIKQ), Female Genital Self-Image Scale (FGSIS-4) and prevalence and severity of urinary incontinence and pelvic organ prolapse (ICIQ-UI Short Form and ICIQ-VS), age, level of education, level of deprivation (according to postcode), faith, first or preferred language spoken, sexual orientation and employment status to explore whether these are associated with barriers to treatment seeking as measured by the Barriers to Incontinence Care Seeking Questionnaire (BICS-Q) and to estimate the prevalence of urinary incontinence and prolapse in a community group of women from an ethnic minority/global majority background
- Collecting qualitative data via semi-structured interviews with women from an ethnic minority/global majority background who have sought treatment for urinary incontinence or pelvic organ prolapse to explore barriers they may have experienced and how these were overcome and collecting qualitative data via focus group discussions with women from an ethnic minority/global majority background who attend women's community groups
- Zine making as a research approach is a creative, participatory method that uses the process of creating zines (small, self-published, often handmade booklets) to generate, explore, and share knowledge . Zine making blends arts-based research and participatory action research and is particularly suited for working with seldom heard communities or exploring stigmatised conditions because it gives participants creative control over how their experiences are communicated, which can be empowering, especially for individuals who are under or misrepresented in mainstream narratives . Zine making is also more accessible for individuals who do not speak English as their first or preferred language, or, have other communication barriers .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with condition | – | Other: No interventionWomen with urinary incontinence or pelvic organ prolapse from an ethnic minority/global majority background who are attending a urogynaecology clinic in the Warrell Unit at Manchester University NHS Foundation Trust. |
| Public | – | Other: No interventionWomen from ethnic minority/global majority background attending community groups in Greater Manchester. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have been referred to MFT for the specified condition. Women attending select community centres in Greater Manchester area.
Key inclusion criteria (11 listed)
- To be willing and able to give informed consent
- To have been born female and to currently identify as female
- To be over the age of 18 years
- To have accessed medical care for urinary incontinence or pelvic organ prolapse
- To be from an ethnic minority/ global majority background
Key exclusion criteria (3 listed)
- -
- Women attending select community centres in Greater Manchester area.
- -
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 |
|---|---|---|
| No interventionno intervention | Other | Patients with condition, Public |
Primary outcome
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Time frame: 12 months
* 24 statements, with three responses: "Agree," "Disagree," or "I don't know". Each correct answer is scored 1, incorrect or not known answers score as a 0. Total score is calculated by adding each score together with a maximum total of 24. * The higher the score the greater the knowledge of prolapse and incontinence.
Barriers to Incontinence Care Seeking questionnaire (BICS-Q)
Time frame: 12 months
* BICS-Q consists of 14 questions that address different barriers to incontinence care seeking. * Each question is scored between 0-3 based on level of agreement with the statement. * BICS-Q is scored on a scale of 0 to 42. * The higher the score the more barriers to care seeking.
3 secondary outcomes
International Consultation on Incontinence Questionnaire (ICIQ UI Short Form)
Time frame: 12 months
International Consultation on Incontinence Questionnaire and Vaginal Symptoms (ICIQ VS)
Time frame: 12 months
Female Genital Self-Image Scale (FGSIS-4)
Time frame: 12 months
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Lucy Dwyer, PhD principal investigator
Manchester University Hospitals NHS Foundation Trust
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 Prolapse Conditions, run by Manchester University NHS Foundation Trust 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 11 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: opening soon, as of the sponsor's last update on 30 Dec 2025. 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?
Contact Stuart Ingram, MsC (0161 ext. 0300 3309444, stuart.ingram@mft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolapse and Incontinence Knowledge Questionnaire (PIKQ) (time frame: 12 months). The study lists 2 primary outcomes in all. 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 30 Dec 2025.