Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Study Overview
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Brief Summary
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Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running, lifting or walking. SUI cause women to avoid routine physical activities, thus detracting significantly from their quality of life. The purpose of this study is to evaluate the performance of new designs of the TIPI device, a conservative, disposable, treatment for temporary management of SUI.

Official Title
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Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: TIPI vaginal pessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged 18 to 60 years Had ≥ 1 deliveries Suffering from genuine stress urinary incontinence confirmed by urodynamic testing (Urodynamic stress urinary incontinence) and normal voiding without abnormal residual urine Baseline PWG (no usage of TIPI device) ≥ 6gr/8hrs Average reduction of urinary incontinence of at least 70% following 3 days usage of the cleared TIPI G3 device The patient has the ability to understand the nature of the study and give her consent by signing a written informed consent form. Successful experience with the use of vaginal tampons Willing to undergo urodynamic investigation Normal pap smear within past 24 months Patient is able and agrees to arrive to the study site area for a period of about 4-6 hours during 6-12 non consequent study days. Exclusion Criteria: Patient is pregnant, or suspected to be pregnant or is planning to be pregnant during the course of the study Patients with present or suspected urinary infection Patients with present or suspected vaginal infection Severely atrophic vagina Women who did not manage to insert a vaginal tampon, for any reason, in the past Abnormal vaginal bleeding Patient is currently participating in another clinical study that may directly or indirectly affect the results of this study Was/is being treated for urinary incontinence by other means such as medications, surgical intervention etc. that might influence study results Vaginal wall prolapse of any type reaching the level of the introitus (grade 2) Co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TIPI vaginal pessary<br>Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all types of SMD's | Device: TIPI vaginal pessary<br>* TIPI vaginal pessary G3 model, and TIPI SMD's<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percentage of Pad Weight Gain (PWG) Change | All eligible subjects underwent a 3-day Pad period to establish baseline Average PWG. During this period, pre-weighed pads were worn for 8 hours a day and subjects were asked to perform predefined physical activities and drink a certain amount of liquid, daily. Pads were collected and weighed in the clinic to determine baseline urine leakage. Subjects then used SMDs or the cleared TIPI (G3) with pads for up to 8 hours. The average PWG tests results with the TIPI devices were compared to the average PWG 8 hrs test without the device and were presented as percentages. The efficacy endpoint for the study was mean percent change of PWG using a certain device compared to the values obtained at the baseline period, as calculated by the following formula: % Reduction = 1-(Device/Baseline )*100 Where, Device = the average pad weight gain (PWG) during device usage. Baseline = the average pad weight gain (PWG) during the days of baseline period. | up to 8 hours of use |