Feasibility Study Evaluating the ParaPatch System
Completed · Not applicable
Conditions studied: Urinary Incontinence
In brief
A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.
Key facts
- Study ID
- NCT02278146
- Run by
- ParaPatch, Inc
- People needed
- 16
- Starts
- 2014-11-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-01-24
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Skyline Urology — Sherman Oaks, California, United States
- Skyline Urology — Torrance, California, United States
Full record on ClinicalTrials.gov
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