Pelvic Floor Disorders Among Sexual Minoritized Women (PRIDE)

January 10, 2024 updated by: University of New Mexico
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

New patients over the age of 18 who present to urogynecology office or contact the research team with interest in participating in the study who self-identify as women who have sex with women. This may include but is not limited to: lesbian and bisexual women.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative impact of pelvic floor disorders on sexual function
Time Frame: 6 months
We will assess the impact of pelvic floor disorders with qualitative analysis and informational interviews
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative inclusivity of sexual function questionnaires
Time Frame: 6 months
We will examine this with guided focus groups
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of New Mexico

Collaborators

University of Texas at Austin
Albany Medical College

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Actual)

June 29, 2022

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

September 27, 2021

First Posted (Actual)

October 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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