Status:

RECRUITING

Pessary Experience Study

Lead Sponsor:

University of Virginia

Conditions:

Pelvic Organ Prolapse

Stress Urinary Incontinence

Eligibility:

FEMALE

18+ years

Brief Summary

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical ca...

Detailed Description

Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ prolapse or stress urinary incontinence. They are adequate treatment options for patients who are poor surgical ca...

Eligibility Criteria

Inclusion

  • English-speaking women aged 18 years or older
  • Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or stress urinary incontinence at the University of Virginia Pelvic Medicine and Reconstructive Surgery clinic
  • Willingness and ability to comply with scheduled visits and study procedures.
  • Successful pessary fitting

Exclusion

  • Pregnant women
  • Prisoners
  • Cognitively impaired
  • Non-English speaking subjects
  • Patients who cannot comply with pessary check visits
  • Active vaginal infection
  • Vaginal malignancy
  • Genitourinary tract fistula

Key Trial Info

Start Date :

June 12 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT06021769

Start Date

June 12 2023

End Date

December 1 2026

Last Update

January 28 2025

Active Locations (1)

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1

University of Virginia

Charlottesville, Virginia, United States, 22903