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 |
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.
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.
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
Click here to add this to my saved trials

Click here to add this to my saved trials
