Pelvic Floor Disorders Among Sexual Minoritized Women

NCT05072158 | Terminated

• 1 other identifier: 21-196
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Function Disturbances; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Qualitative inclusivity of sexual function questionnaires

  6 months

Interventions

None, this is an observational study OTHER

This is a qualitative study, we will be asking for patient experiences with PFDs and the impact on their sexual function.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This trial is open only to wmen
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• WSW who have a PFD (pelvic organ prolapse, urinary incontinence, fecal incontinence)
• Age \>18
• Able to provide consent
• Able to read/write in English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• Albany Medical College: collaborator
• University of Texas at Austin: collaborator

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Sexual Dysfunctions, Psychological; Pelvic Organ Prolapse; Urinary Incontinence; Fecal Incontinence

Condition Hierarchy (Ancestors)

Mental Disorders; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sierra Jansen, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: October 8, 2021
• Study Start: October 14, 2021
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)