Urinary Incontinence Clinical Trials

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Longitudinal Assessment of Pessary Experience

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Monique Vaughan, MD
mv4w@UVAHEALTH.ORG
4349261955
Backup
Monique Vaughan, MD
mv4w@UVAHEALTH.ORG
4349242103
Time Frame
Start Date: 2023-06-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 30
Treatments
Women being fitted with pessaries
Women being fitted with pessaries as standard of care will be eligible to participate. They will be asked to complete a recorded verbal interview and written questionnaires the day they have their pessaries fitted and at their follow-up clinic appointments at 4-6 weeks, 3 months, 6 months, and 12 months. Another recorded video interview will be completed at the 12 month appointment.
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov