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

NCT07310121 | Not Yet Recruiting

• 2 other identifiers: B0263725/WA/0334
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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 .

Conditions

Pelvic Prolapse Conditions

Keywords

Pelvic organ prolapse; Pelvic floor dysfunction; Urinary incontinence

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 months

Secondary Outcomes (3)

• International Consultation on Incontinence Questionnaire (ICIQ UI Short Form)

  12 months

• International Consultation on Incontinence Questionnaire and Vaginal Symptoms (ICIQ VS)

  12 months

• Female Genital Self-Image Scale (FGSIS-4)

  12 months

Study Arms (2)

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

No intervention OTHER

no intervention

Patients with condition; Public

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Women attending select community centres in Greater Manchester area.
• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• Burdett Trust for Nursing: collaborator

Study Sites (1)

Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Lucy Dwyer, PhD

  Manchester University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart Ingram, MsC

CONTACT

0161; stuart.ingram@mft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)