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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02278146
• Other study ID #: PP-01-2014
• Status: Active, not recruiting
• Phase: N/A
• First received: October 21, 2014
• Last updated: March 28, 2016
• Start date: November 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: ParaPatch, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

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

Intervention

Device:
• ParaPatch
A device for the treatment of urinary incontinence

Locations

Country	Name	City	State
United States	Skyline Urology	Sherman Oaks	California
United States	Skyline Urology	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
ParaPatch, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.		up to 3 weeks	Yes
Secondary	Stress Incontinence Arm	Stress Incontinence Arm - Daily Leak Frequency	up to 3 weeks	No
Secondary	Overactive Bladder Arm	OAB Arm - Daily voids	up to 3 weeks	No