RECRUITING

Pessary Experience Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Longitudinal Assessment of Pessary Experience

Quick Facts

Study Start:2023-06-12
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06021769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English-speaking women aged 18 years or older
  2. * 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
  3. * Willingness and ability to comply with scheduled visits and study procedures.
  4. * Successful pessary fitting
  1. * Pregnant women
  2. * Prisoners
  3. * Cognitively impaired
  4. * Non-English speaking subjects
  5. * Patients who cannot comply with pessary check visits
  6. * Active vaginal infection
  7. * Vaginal malignancy
  8. * Genitourinary tract fistula

Contacts and Locations

Study Contact

Monique Vaughan, MD
CONTACT
4349261955
mv4w@UVAHEALTH.ORG
Monique Vaughan, MD
CONTACT
4349242103
mv4w@UVAHEALTH.ORG

Principal Investigator

Monique Vaughan, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: University of Virginia

  • Monique Vaughan, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-12
Study Completion Date2024-12

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • pessary

Additional Relevant MeSH Terms

  • Pelvic Organ Prolapse
  • Stress Urinary Incontinence