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NCT05072158 Clinical Trial

Pelvic Floor Disorders Among Sexual Minoritized Women

Urinary Incontinence Clinical Trial

— PRIDE  

Official title:
Pelvic Floor Disorders Among Sexual Minoritized Women

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05072158
Other study ID # 21-196
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date October 14, 2021
Est. completion date June 29, 2022

Study information
Verified date January 2024
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aim to perform cognitive interviews to assess how pelvic floor disorders impact sexual functioning in women who have sex with women (WSW). As a secondary objective there will be cognitive interviews to assess perceptions of sexual function questionnaires such as Female Sexual Function Index (FSFI) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire-IUGA Revised (PISQ-IR) in WSW.

Description:

There is a paucity of data regarding care of women who have sex with women (WSW). While some cohort studies are being performed in general gynecology, no studies document the reasons as to why WSW seek urogynecological care, or how pelvic floor disorders (PFDs) affect sexual function in this population. Another detrimental gap in current knowledge and a barrier to care for WSW is the lack of understanding of what would drive WSW to seek care, if there are special considerations for care, or if the commonly used condition specific questionnaires adequately reflect their concerns. The Investigators aim to perform qualitative interviews to understand how PFDs affect sexual function, and if commonly utilized sexual function questionnaires are inclusive to WSW.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date June 29, 2022
Est. primary completion date June 29, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence) - Age >18 - Able to provide consent - Able to read/write in English Exclusion Criteria: - WSW who have not been sexually active in the past 6 months - Incarcerated patients - Pregnant or lactating patients - Unable to consent with study procedures or guided discussions - Unable to speak English - No sexual activity in the past 6 months

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• None, this is an observational study
This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (3)
Lead Sponsor Collaborator
University of New Mexico Albany Medical College, University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative impact of pelvic floor disorders on sexual function We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews 6 months
Secondary Qualitative inclusivity of sexual function questionnaires We will examine this with guided focus groups 6 months
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