Feasibility Study Evaluating the ParaPatch System

Study Overview
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Brief Summary
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A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.

Detailed Description
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Baseline Period o The baseline period will allow for washout of any medication affecting bladder function and to allow subject to begin her voiding diary. Prospective data collection will take place in the form voiding diary. Leak frequency, and other relevant parameters will be collected. Inclusion/exclusion criteria will be rechecked at end of baseline. Qol questionnaires will be completed in the office at the end of baseline period. Evaluation Period o During the evaluation period, the subjects will use the ParaPatch System. No medications affecting bladder function will be allowed during the evaluation period. Subjects will complete voiding diaries, during the evaluation period. Data capture to include: adverse events, medication use, leak frequency and other relevant parameters. Qol questionnaires will be completed in the office at the end of evaluation period. Follow-up Period o Subjects will be followed for after the evaluation period to check for residual Adverse Events. No medications affecting bladder function will be allowed during the follow-up period. Subjects will be called by the clinical coordinator at the end of the Follow-up period and asked about potential Adverse Events.

Official Title
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A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Device: ParaPatch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged from >18 to < 75 years old. Subject has the ability to read and comprehend English, and to reliably record information as required by the Protocol, including the proper completion of the questionnaires. Subject is able to provide written informed consent prior to participation in the study. Diagnosed with either of the following: a) overactive bladder, or b) urinary stress incontinence. Exclusion Criteria: Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. Subject has demonstrated or is believed to be at risk of non-compliance with study procedures (e.g., for completing the diary or returning for required follow-up visits). Subject has undergone onabotulinumtoxin-A injections of the bladder in the last twelve (12) months. Subject is not suitable for the study for any reason (including overall health, pre-existing conditions or medications) in the judgment of the investigator. Have an untreated recurrent urinary tract infection (> 2 times within the past 6 months). Have neurogenic disorders such as Multiple Sclerosis, ALS, or Parkinson s Disease. Patients with a diagnosis of painful bladder syndrome, other pelvic pain or interstitial cystitis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1) Stress urinary incontinence<br>Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System | Device: ParaPatch<br>* A device for the treatment of urinary incontinence<br>|
| Experimental: 2) Overactive bladder<br>Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System | Device: ParaPatch<br>* A device for the treatment of urinary incontinence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study | Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study. | up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress Incontinence Arm | Percentage of participants with less daily leaks from baseline to 3 weeks. | up to 3 weeks | 
| Overactive Bladder Arm | Percentage of participants with less daily voids from baseline to 3 weeks. | up to 3 weeks |