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