Feasibility Study Evaluating the ParaPatch System

Urinary Incontinence Clinical Trial

Official title: A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

• NCT number: NCT02278146
• Study type: Interventional
• Source: ParaPatch, Inc
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Completion date: May 2016