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Active Not Recruiting NCT06021769

Pessary Experience Study

Conditions: Pelvic Organ Prolapse, Stress Urinary Incontinence

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 30
Sponsor: University of Virginia

Location: University of Virginia Charlottesville Virginia

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 candidates, those who decline surgical intervention, or as a temporizing measure in those ultimately planning surgery. Most studies suggest that about 75% of patients are able to be successfully fit with a pessary, but about 50% discontinue pessary use within 12 months of initiation. The purpose of this study is to determine why pessaries are discontinued.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06021769). StuddyBuddy aggregates publicly available trial information.