Pessary Experience Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Virginia
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Pregnant women
Prisoners
Cognitively impaired
Non-English speaking subjects
Trial population
Women in the area surrounding the University of Virginia who have stress urinary incontinences or pelvic organ prolapse.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational only
Other interventionNo intervention
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Women being fitted with pessaries1 intervention
Trial outcomes
Primary outcomes
1
Qualitative analysis
Perform a patient-centered, qualitative analysis of pessary discontinuation
Time frame
up to 1 year after pessary fitting2
Pelvic Floor symptom improvement as related to quality of life
Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires
Time frame
up to 1 year after pessary fitting3
Discontinuation of pessaries
Rates of discontinuation at 1 year
Time frame
up to 1 year after pessary fitting4
Why do women discontinue using pessaries?
Factors significantly associated with discontinuation
Time frame
up to 1 year after pessary fittingSponsors and contacts
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Source ClinicalTrials.gov