Pelvic Floor Disorders Among Sexual Minoritized Women

NCT ID: NCT05072158

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-14

Study Completion Date

2022-06-29

Brief Summary

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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

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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.

Conditions

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Sexual Function Disturbances Pelvic Organ Prolapse Urinary Incontinence Fecal Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Albany Medical College

OTHER

Sponsor Role collaborator

University of Texas at Austin

OTHER

Sponsor Role collaborator

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sierra Jansen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Other Identifiers

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21-196

Identifier Type: -

Identifier Source: org_study_id

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