ClinicalTrials.gg
Not yet recruitingNCT07310121BEAM UP & GLOWUpdated Dec 30, 2025

Barriers and Enablers to Accessing Medical Care for Urinary Incontinence and Prolapse in GLobal Majority Women

An observational study in Pelvic Prolapse Conditions, sponsored by Manchester University NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Manchester University NHS Foundation Trust · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
160
Ages
18 Years and older
Sex
Female
01

Study 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. 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
  2. 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
  3. 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 .
02

Conditions studied

  • Pelvic Prolapse Conditions

Keywords

  • Pelvic organ prolapse
  • Pelvic floor dysfunction
  • Urinary incontinence
03

In context

Pelvic Organ Prolapse

521 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's planned enrollment of 160 is above the median of 134 across 171 observational studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women who have been referred to MFT for the specified condition. Women attending select community centres in Greater Manchester area.

Eligibility criteria

Women who have been referred to MFT for the specified condition.

Inclusion Criteria:

  • To be willing and able to give
  • 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

Exclusion Criteria:

-

Women attending select community centres in Greater Manchester area.

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
160 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: No intervention

  • Public

    Women from ethnic minority/global majority background attending community groups in Greater Manchester.

    Other: No intervention

Interventions

  • OtherNo intervention

    no intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: 12 months

  3. 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.

    Time frame: 12 months

07

Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07310121
Collaborators
Burdett Trust for Nursing
Responsible party
Sponsor
First posted
Dec 30, 2025
Start date
Dec 2025 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Dec 30, 2025

Study contacts

Stuart Ingram, MsC
Contact
stuart.ingram@mft.nhs.uk
0161 ext. 0300 3309444
Lucy Dwyer, PhD
principal investigator · Manchester University Hospitals NHS Foundation Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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