Pelvic Floor Disorders Among Sexual Minoritized Women

Terminated

• Conditions: Pelvic Organ Prolapse; Urinary Incontinence; Sexual Function Disturbances; Fecal Incontinence

• Registration Number: NCT05072158
• Lead Sponsor: University of New Mexico

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-08-18
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-08
• Study Start: 2021-10-14
• Primary Completion: 2022-06-29
• Study Completion: 2022-06-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 18

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Qualitative impact of pelvic floor disorders on sexual function	6 months	We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews

Secondary Outcome Measures

Name	Time	Method
Qualitative inclusivity of sexual function questionnaires	6 months	We will examine this with guided focus groups

Trial Locations

Locations (1)

University of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States