- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310121
Barriers and Enablers to Accessing Medical Care for Urinary Incontinence and Prolapse in GLobal Majority Women (BEAM UP & GLOW)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stuart Ingram, MsC
- Phone Number: 0300 3309444 0161
- Email: stuart.ingram@mft.nhs.uk
Study Locations
-
-
-
Manchester, United Kingdom, M13 9WL
- Manchester University Hospitals NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
no intervention
|
|
Public
Women from ethnic minority/global majority background attending community groups in Greater Manchester.
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prolapse and Incontinence Knowledge Questionnaire (PIKQ)
Time Frame: 12 months
|
|
12 months
|
|
Barriers to Incontinence Care Seeking questionnaire (BICS-Q)
Time Frame: 12 months
|
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
International Consultation on Incontinence Questionnaire (ICIQ UI Short Form)
Time Frame: 12 months
|
|
12 months
|
|
International Consultation on Incontinence Questionnaire and Vaginal Symptoms (ICIQ VS)
Time Frame: 12 months
|
|
12 months
|
|
Female Genital Self-Image Scale (FGSIS-4)
Time Frame: 12 months
|
|
12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lucy Dwyer, PhD, Manchester University Hospitals NHS Foundation Trust
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Prolapse
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
- Pelvic Organ Prolapse
Other Study ID Numbers
- B02637
- 25/WA/0334 (Other Identifier: NHS Research Ethics)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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