Not yet recruiting NCT07310121

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

— Observational Pelvic Prolapse Conditions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: No intervention.
Who it may be relevant to: Registry conditions: Pelvic Prolapse Conditions. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United Kingdom
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 .

Interventions

Other No intervention
no intervention

Primary outcome measures

Prolapse and Incontinence Knowledge Questionnaire (PIKQ) [Time frame: 12 months]
Barriers to Incontinence Care Seeking questionnaire (BICS-Q) [Time frame: 12 months]

Secondary outcome measures (3)

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]

Eligibility criteria

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

Inclusion criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Other

Study locations

United Kingdom · 1 center

Manchester University Hospitals NHS Foundation Trust — Manchester

Identifiers

NCT: NCT07310121 · B02637 · 25/WA/0334

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗