Understanding why women stop using pessaries for pelvic organ prolapse and urinary incontinence
Longitudinal Assessment of Pessary Experience
This study looks at why many women stop using pessaries for pelvic organ prolapse and urinary incontinence within a year, to help improve their experience and satisfaction with this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT06021769 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the use of pessaries, silicone devices inserted into the vagina to treat pelvic organ prolapse and stress urinary incontinence. It aims to identify the reasons why approximately 50% of women discontinue pessary use within 12 months, despite a high initial fitting success rate. The study will gather data on patient experiences, satisfaction, and any adverse effects related to pessary use. By analyzing these factors, the research seeks to improve patient outcomes and satisfaction with pessary treatment.
Who should consider this trial
Good fit: Ideal candidates are English-speaking women aged 18 and older who are seeking a pessary fitting for pelvic organ prolapse or stress urinary incontinence.
Not a fit: Patients who are pregnant, cognitively impaired, or have active vaginal infections or malignancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pessary use and improve patient retention and satisfaction with this treatment option.
How similar studies have performed: While there is existing research on pessary use, this study aims to provide new insights into the reasons for discontinuation, making it a valuable addition to the current literature.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Monique Vaughan, MD — Assistant Professor
- Study coordinator: Monique Vaughan, MD
- Email: mv4w@UVAHEALTH.ORG
- Phone: 4349261955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.