Overview

This trial is active, not recruiting.

Condition urinary incontinence
Treatment parapatch
Sponsor ParaPatch, Inc
Start date November 2014
End date December 2015
Trial size 60 participants
Trial identifier NCT02278146, PP-01-2014

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
parapatch
A device for the treatment of urinary incontinence
(Experimental)
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
parapatch
A device for the treatment of urinary incontinence

Primary Outcomes

Measure
Characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.
time frame: up to 3 weeks

Secondary Outcomes

Measure
Stress Incontinence Arm
time frame: up to 3 weeks
Overactive Bladder Arm
time frame: up to 3 weeks

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

Official title A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by ParaPatch, Inc.