Status:
COMPLETED
Feasibility Study Evaluating the ParaPatch System
Lead Sponsor:
ParaPatch, Inc
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.
Detailed Description
* 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02278146
Start Date
November 1 2014
End Date
February 1 2016
Last Update
January 24 2017
Active Locations (2)
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1
Skyline Urology
Sherman Oaks, California, United States, 91411
2
Skyline Urology
Torrance, California, United States, 90505