RANDOMIZED PLACEBO-CONTROLLED SINGLE BLINDED MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF YONI.FIT IN WOMEN WITH STRESS URINARY INCONTINENCE (SUI)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Stress Incontinence
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other Inclusion Criteria:
    1. Female subjects with BMI less than 35
    2. Subjects must be clinical diagnosised with SUI clinical diagnosis via the cough supine test, AND have more than 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms
    3. Women of childbearing potential not intending to become pregnant for the duration of study participation. Subject must agree for the duration of the study to use systemic hormonal treatment, or single barrier contraceptions or have the essure procedure at least 3 months prior to screening.
    4. Subjects who are willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits
    5. Subjects must be able to speak, understand and read English and sign study specific Informed Consent

You may not be eligible for this study if the following are true:

    1. Subjects having predominantly urge or mixed incontinence as defined by QUID Urge score >6, OR MESA percentage Urge Score > MESA percentage Stress Score
    2. Subjects who are pregnant or planning for pregnancy in the next 6 months
    3. Subjects at postpartum for 3 months or less prior to screening
    4. Subjects currently use or have used any intrauterine device (IUD) or intra-vaginal device as contraception method for past six months
    5. Subjects currently using a pessary or treated previously with any device for UI
    6. Subjects who have been treated with pharmacologic medications for UI within the past 4 months prior to screening, including any antidiuretic medications (both over the counter and prescription medications)
    7. Subjects who have been previously treated with any surgical or electrical interventions for UI.



If you are registered as a volunteer, please login to the dashboard to send referrals.

Contact the research team to learn more about this study.

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