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PRIDE: Pelvic Floor Disorders Among Sexual Minoritized Women

Sponsor
University of New Mexico (Other)
Overall Status
Recruiting
CT.gov ID
NCT05072158
Collaborator
Albany Medical College (Other), University of Texas at Austin (Other)
30
Enrollment
1
Location
9.6
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: None, this is an observational study

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 Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pelvic Floor Disorders Among Sexual Minoritized Women
Actual Study Start Date :
Oct 14, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Qualitative inclusivity of sexual function questionnaires [6 months]

    We will examine this with guided focus groups

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of New Mexico Albuquerque New Mexico United States 87106

Sponsors and Collaborators

  • University of New Mexico
  • Albany Medical College
  • University of Texas at Austin

Investigators

  • Principal Investigator: Sierra Jansen, MD, University of New Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT05072158
Other Study ID Numbers:
  • 21-196
First Posted:
Oct 8, 2021
Last Update Posted:
Oct 25, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Fecal Incontinence
Urinary Incontinence
Pelvic Floor Disorders
Prolapse
Pelvic Organ Prolapse

Study Results

No Results Posted as of Oct 25, 2021