Back to resultsFeasibility Study Evaluating the ParaPatch System
Primary Purpose
Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ParaPatch
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Incontinence
Eligibility 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.
Sites / Locations
- Skyline Urology
- Skyline Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1) Stress urinary incontinence
2) Overactive bladder
Arm Description
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Stress Incontinence Arm
Percentage of participants with less daily leaks from baseline to 3 weeks.
Overactive Bladder Arm
Percentage of participants with less daily voids from baseline to 3 weeks.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02278146
Brief Title
Feasibility Study Evaluating the ParaPatch System
Official Title
A Multi-center, Open-label, Prospective, Feasibility Study Evaluating the ParaPatch System for the Treatment of Urinary Incontinence and Overactive Bladder
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ParaPatch, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A multi-center, open-label, prospective, feasibility study evaluating the ParaPatch System for the treatment of urinary incontinence and overactive bladder.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1) Stress urinary incontinence
Arm Type
Experimental
Arm Description
Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System
Arm Title
2) Overactive bladder
Arm Type
Experimental
Arm Description
Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System
Intervention Type
Device
Intervention Name(s)
ParaPatch
Intervention Description
A device for the treatment of urinary incontinence
Primary Outcome Measure Information:
Title
Number of Participants Who Used the ParaPatch System With Adverse Events Through the Completion of the Study
Description
Documentation, follow-up and 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 Outcome Measure Information:
Title
Stress Incontinence Arm
Description
Percentage of participants with less daily leaks from baseline to 3 weeks.
Time Frame
up to 3 weeks
Title
Overactive Bladder Arm
Description
Percentage of participants with less daily voids from baseline to 3 weeks.
Time Frame
up to 3 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy Santa Cruz
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Skyline Urology
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91411
Country
United States
Facility Name
Skyline Urology
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Feasibility Study Evaluating the ParaPatch System
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