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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Fecal Incontinence
• Pelvic Floor Disorders
• Pelvic Organ Prolapse
• Prolapse
• Sexual Function Disturbances
• Urinary Incontinence

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