Pessary Experience Study

NCT06021769 | Recruiting

• 1 other identifier: HSR220160
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

pessary

Outcome Measures

Primary Outcomes (4)

• Qualitative analysis

  Perform a patient-centered, qualitative analysis of pessary discontinuation

  up to 1 year after pessary fitting

• 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

  up to 1 year after pessary fitting

• Discontinuation of pessaries

  Rates of discontinuation at 1 year

  up to 1 year after pessary fitting

• Why do women discontinue using pessaries?

  Factors significantly associated with discontinuation

  up to 1 year after pessary fitting

Study Arms (1)

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.

Other: Observational only

Interventions

Observational only OTHER

No intervention

Women being fitted with pessaries

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women in the area surrounding the University of Virginia who have stress urinary incontinences or pelvic organ prolapse.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

Related Publications (3)

• Yimphong T, Temtanakitpaisan T, Buppasiri P, Chongsomchai C, Kanchaiyaphum S. Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1123-1128. doi: 10.1007/s00192-017-3445-x. Epub 2017 Aug 16.

  PMID: 28815277 BACKGROUND

• Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15.

  PMID: 27525693 BACKGROUND

• Umachanger JK, Marcussen ML, Boggild H, Kjaergaard N, Glavind K. First-line treatment of pelvic organ prolapse and discontinuation of pessary treatment. Int Urogynecol J. 2020 Sep;31(9):1813-1819. doi: 10.1007/s00192-020-04338-w. Epub 2020 May 24.

  PMID: 32447418 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms

Study Officials

• Monique Vaughan, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Monique Vaughan, MD

CONTACT

4349261955; mv4w@UVAHEALTH.ORG

Monique Vaughan, MD

CONTACT

4349242103; mv4w@UVAHEALTH.ORG

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: June 12, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)