Feasibility Study Evaluating the ParaPatch System

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence
• Intervention / Treatment: Device: ParaPatch

Detailed 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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sherman Oaks, California, United States, 91411
      • Skyline Urology
    • Torrance, California, United States, 90505
      • Skyline Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1) Stress urinary incontinence; Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System	Device: ParaPatch; A device for the treatment of urinary incontinence
Experimental: 2) Overactive bladder; Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System	Device: ParaPatch; A device for the treatment of urinary incontinence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study	Documentation, follow-up and characterization of all adverse events in all subjects who use the ParaPatch System, through the completion of the study.	up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress Incontinence Arm	Percentage of participants with less daily leaks from baseline to 3 weeks.	up to 3 weeks
Overactive Bladder Arm	Percentage of participants with less daily voids from baseline to 3 weeks.	up to 3 weeks

Collaborators and Investigators

• Sponsor: ParaPatch, Inc
• Investigators: Study Director: Cindy Santa Cruz, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 27, 2014
• First Posted (Estimate): October 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis
• Other Study ID Numbers: PP-01-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED