RecruitingNCT06021769

Pessary Experience Study

Longitudinal Assessment of Pessary Experience


Sponsor

University of Virginia

Enrollment

30 participants

Start Date

Jun 12, 2023

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

OTHERObservational only

No intervention


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT06021769