Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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Study to evaluate the safety and effectiveness of Yoni.Fit for the temporary management of stress urinary incontinence (SUI) in women.

Detailed Description
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Randomized, comparator-controlled, single blinded, multicenter study to demonstrate the effectiveness, user acceptance, safety and tolerability of Yoni.Fit in the temporary management of stress urinary incontinence (SUI) in women.

Official Title
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Randomized, Comparator-controlled, Single Blinded, Multi-center Study Evaluating the Efficacy and Safety of Yoni.Fit in Women With Stress Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: Yōni.Fit Test Device
* Device: Yōni.Fit Comparator Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be female, Must be 18 years of age or older at the time of signing the informed consent With BMI < 35 Must meet the following 2 criteria for diagnosis of stress urinary incontinence (SUI) : SUI clinical diagnosis via the cough supine test, AND ≥ 3 month history of experiencing Stress Urinary Incontinence (SUI) symptoms per the patient 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 one of the following forms of contraception Systemic hormonal treatment including oral pills, patches and injections OR Single-barrier contraception (condom, diaphragm and spermicide are each considered a barrier) OR Essure® procedure done at least three month prior to screening Willing to comply with study requirements, including capable of performing the activities required for the pad weight test and return for follow-up visits. Must be able to speak, understand and read English and sign study specific Informed Consent Form Exclusion Criteria: Women having predominantly urge or mixed incontinence as defined by: QUID Urge score >6, OR MESA percentage Urge Score > MESA percentage Stress Score Note: the questionnaires above will be self-administered and results interpreted by the subjects as per instructions in the questionnaires. Current pregnancy, lactation or planning for pregnancy in the next 6 months Women at postpartum for 3 months or less prior to screening Women currently have an intrauterine device (IUD) as a contraception method placement less than 6 months or have an IUD over 6 month but may replace it next 14 weeks Women currently use, have used an intra-vaginal device as contraception method for the past 6 months Women currently using a pessary or treated previously with any device for UI Women who have been treated with pharmacologic medications for UI within the past 4 months prior to screening, including any antidiuretic or diuretic medications (both over the counter and prescription medications) Women who have been previously treated with any surgical or electrical interventions for UI Women who have been previously treated with pelvic floor muscle training (PFMT) for UI within the past 4 months prior to screening Women who have difficulty inserting or wearing an intra-vaginal device, including a tampon Women who participated in a clinical trial within the 12 months prior to screening Any of the following known conditions deemed prohibitory: Abnormal kidney function, including kidney stone Abnormal post void residual (e.g. greater than 150cc) or self-reported difficulty emptying bladder Allergy to silicon products and materials Acute febrile illness of any cause in the 14 days prior to screening Bladder stones or Bladder tumors Chronic pelvic pain within the past 4 months prior to screening Coagulation abnormalities Experience pain or burning sensation during sexual intercourse or urination Infections of the vagina, bladder and/or urethra within previous 3 months such as urinary tract infection (UTI) Interstitial cystitis Neurological disorders such as multiple sclerosis, spina bifida, Parkinson's disease which may interfere with nerve function of the bladder. Toxic shock syndrome (TSS) history or symptoms consistent with TSS Uncontrolled diabetes Undiagnosed vaginal bleeding or hematuria Vaginal discharge with a strong odor and irritation within previous 3 months Vaginal soreness or pain or fibromyalgia or paravaginal defect Any other medical reason that the Investigator determines that the subject should not participate in the study Known history of previous pelvic organ prolapse greater than the POP-Q Stage 2 as defined by the international continence society (ICS).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Device<br>Yōni.Fit Test Device | Device: Yōni.Fit Test Device<br>* The Yōni.Fit Test Device is a silicone pessary.<br>|
| Active Comparator: Comparator Device<br>Yōni.Fit Comparator Device | Device: Yōni.Fit Comparator Device<br>* The Yōni.Fit Comparator Device is a silicone pessary with a different configuration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate at Day 21 | Responder rate at Day 21, where responder is defined as a subject who has at least 50% reduction in mean 12-hour pad weight test through assessment period of treatment phase (the last 7 days of 14-day device usage period), when compared to the mean pad weight test during the 7-day baseline phase | 21 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in mean pad weight | Percent change in mean pad weight during assessment period of treatment phase (the last 7 days of 14-day device usage period), from the mean pad weight during the 7-day baseline phase | 7 Days, 14 Days | 
| Percent change in the frequency of SUI events per the patient diary | Percent change in the frequency of SUI events per the patient diary, defined as average number of incontinence episodes per 12 hours during assessment period of treatment phase (the last 7 days of 14-day device usage period), from the average of baseline phase | 7 Days, 14 Days | 
| Responder rate for frequency of SUI events per the patient diary at Day 21, | Where responder is defined as a subject who has at least 50% reduction in the number of incontinence episodes per day during the last 7 days of | 21 Days | 
| Percent change in Incontinence Impact Questionnaire (IIQ-7) score | 7 questions about how urinary incontinence has affected a subjects life. Questions cover physical activity, travel, social relationships and emotional health. The questionnaire asks whether the subjects life has been greatly affected, moderately, slightly or not affected at all. | 21 Days | 
| Percent change in Patient Global Impression of Change (PGIC) score | It gives a patient reported assessment of change after intervention. The higher the score, the greater the severity (1 being very much improved; 7 very much worse). | 21 Days | 
| Percent change in Incontinence-Quality of Life (I-QOL) Assessment Questionnaire | The I -QOL consists of 22 items, all of which use a five - point ordinal response scale in which 1 = extremely, 2 = quite a bit, 3 = moderately, 4 = a little, and 5 = not at all. The 22 items can be further grouped into 3 sub-scales: Avoidance and Limiting Behaviour (8 ite ms), Psychosocial Impacts (9 items), and Social Embarrassment (5 items). The total I -QOL and 3 sub scale scores are calculated by summing the unweighted item score and transforming them to a 100 point scale where 0 = mo st severe, and 100 = no problem . | 21 Days | 
| Ease of use per the USE Questionnaire: Usefulness, Satisfaction, and Ease of Use | The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The Usefulness section of the questionnaire consists of 19 questions regarding usability of the device scaled from 1- strongly disagree to 7- strongly agree. | 21 Days | 
| Ease of use per the USE Questionnaire: Satisfaction | The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The Usefulness section of the questionnaire consists of 7 questions regarding Satisfaction with the device scaled from 1-strongly disagree to 7-Strongly Agree. | 21 Days | 
| Ease of use per the USE Questionnaire:Ease of Use | The USE questionnaire is meant to be used to assess the Subjective reactions to the usability of the Yōni.Fit ® device. The Usefulness section of the questionnaire consists of 11 questions regarding Ease of Use with the device scaled from 1-strongly disagree to 7-Strongly Agree. | 21 Days |