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Feasibility Study Evaluating the ParaPatch System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278146
Recruitment Status : Completed
First Posted : October 29, 2014
Results First Posted : January 24, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
ParaPatch, Inc

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

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: ParaPatch Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. Stress Incontinence Arm [ Time Frame: up to 3 weeks ]
    Percentage of participants with less daily leaks from baseline to 3 weeks.

  2. Overactive Bladder Arm [ Time Frame: up to 3 weeks ]
    Percentage of participants with less daily voids from baseline to 3 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278146


Locations
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United States, California
Skyline Urology
Sherman Oaks, California, United States, 91411
Skyline Urology
Torrance, California, United States, 90505
Sponsors and Collaborators
ParaPatch, Inc
Investigators
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Study Director: Cindy Santa Cruz Sponsor GmbH

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Responsible Party: ParaPatch, Inc
ClinicalTrials.gov Identifier: NCT02278146    
Other Study ID Numbers: PP-01-2014
First Posted: October 29, 2014    Key Record Dates
Results First Posted: January 24, 2017
Last Update Posted: January 24, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders