Pessary Experience Study

NCT ID: NCT06021769

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2026-12-31

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.

Detailed 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.

Research concerning pessary discontinuation is currently focused on identifying factors that will predict outcomes of pessary use. It is generally agreed upon that pessaries are one of the favored option to conservatively treat pelvic organ prolapse or stress urinary incontinence, but there is not sufficient consensus on the rate of discontinuation, factors leading to discontinuation, and patient satisfaction.

Most studies recorded reasons for discontinuation and any adverse events. Patients' reasons for discontinuation of pessary use included frequent expulsion, difficulty removing pessary, new or worsening urinary incontinence, vaginal erosion, and pain/discomfort. Significant side effects or adverse events included vaginal discharge and erosion.

Several studies focused on anatomic and medical variables that were correlated to pessary discontinuation. A univariate analysis of factors contributing to discontinuation conducted by Yimphong et al.1 found that higher BMI and history of pelvic surgery were significant in predicting discontinuation. Similarly, Panman2 et al. conducted a multivariate analysis that found higher BMI was a significant factor. Panman et al. also found that both younger age and weaker pelvic floor muscles were predictors for discontinuation. The former finding is further supported by Umchanger et al., which cited that 33% of patients who discontinued pessary use within three months were generally less than 65 years. Umchanger et al. hypothesized that despite data suggesting that pessaries are as effective as surgery, younger patients may maintain the misconception that pessaries are not as effective.

Despite the data suggesting contributing factors such as BMI and age, none of the reviewed studies captured the qualitative reasoning behind patients' decisions. Only a few of the studies investigate patients' satisfaction with pessary use, quality of life, or opinion on their treatment.

Pessary use has been correlated to a wide variety of factors, such as a patient's medical history, anatomic characteristics, beliefs about pessary use, and personal satisfaction with treatment. Based on this review, a qualitative analysis of patient experience and priorities as they decide to continue or discontinue pessary use would be incredibly helpful for counseling and educating future patients when they are making treatment decisions about pessaries.

Conditions

Pelvic Organ Prolapse; Stress Urinary Incontinence

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observational only

Intervention Type: OTHER

No intervention

Interventions

Observational only

No intervention

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Monique Vaughan, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Monique Vaughan, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

University of Virginia

Charlottesville, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monique Vaughan, MD

Role: CONTACT

mv4w@UVAHEALTH.ORG

4349261955

Monique Vaughan, MD

Role: CONTACT

mv4w@UVAHEALTH.ORG

4349242103

References

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.

Reference Type: BACKGROUND

PMID: 28815277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27525693 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32447418 (View on PubMed)

Other Identifiers

HSR220160

Identifier Type: -

Identifier Source: org_study_id