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NCT Number: NCT06021769

Pessary Experience Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational only

Other

No intervention

Primary outcomes

  1. Qualitative analysis

    Time frame: up to 1 year after pessary fitting

    Perform a patient-centered, qualitative analysis of pessary discontinuation

  2. Pelvic Floor symptom improvement as related to quality of life

    Time frame: up to 1 year after pessary fitting

    Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires

  3. Discontinuation of pessaries

    Time frame: up to 1 year after pessary fitting

    Rates of discontinuation at 1 year

  4. Why do women discontinue using pessaries?

    Time frame: up to 1 year after pessary fitting

    Factors significantly associated with discontinuation

Study contacts

Contact information is provided by the study sponsor or research team.

Monique Vaughan, MD

CONTACT

[email protected]

4349261955

Monique Vaughan, MD

CONTACT

[email protected]

4349242103

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Official study title

Longitudinal Assessment of Pessary Experience

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 1, 2023
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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