Feasibility Study Evaluating the ParaPatch System



Status:Active, not recruiting
Conditions:Overactive Bladder, Urology
Therapuetic Areas:Gastroenterology, Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:November 2014
End Date:May 2016

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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

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

- 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.

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.
We found this trial at
2
sites
Torrance, California 90505
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Torrance, CA
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Sherman Oaks, California 91411
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Sherman Oaks, CA
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