Recruiting

Pessary

Sponsor:

University of Virginia

Code:

NCT06021769

Conditions

Pelvic Organ Prolapse

Stress Urinary Incontinence

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Observational only

Study Details

Brief 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.

Conditions

Pelvic Organ Prolapse

Stress Urinary Incontinence

Study ID

NCT06021769

Start date

Jun 12, 2023

Status verified date

Jan, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Observational only

No intervention

Primary outcome measure

  • Qualitative analysis [ Time Frame: up to 1 year after pessary fitting ]
  • Pelvic Floor symptom improvement as related to quality of life [ Time Frame: up to 1 year after pessary fitting ]
  • Discontinuation of pessaries [ Time Frame: up to 1 year after pessary fitting ]
  • Why do women discontinue using pessaries? [ Time Frame: up to 1 year after pessary fitting ]

Central Contacts and Locations

Central contacts

Monique Vaughan, MD

4349261955mv4w@UVAHEALTH.ORG

Monique Vaughan, MD

4349242103mv4w@UVAHEALTH.ORG

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

University of Virginia

Last update posted

Jan 28, 2025

Last verified

Jan, 2025

Keywords

  • pessary

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2025-01-28.