Feasibility Study Evaluating the ParaPatch System

• 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: ParaPatch, Inc
• Information provided by (Responsible Party): ParaPatch, Inc

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, California

Skyline Urology

Sherman Oaks, California, United States, 91411

Skyline Urology

Torrance, California, United States, 90505

Sponsors and Collaborators

ParaPatch, Inc

Investigators

• Study Director: Cindy Santa Cruz; Sponsor GmbH

More Information

• Responsible Party: ParaPatch, Inc
• ClinicalTrials.gov Identifier: NCT02278146
• Other Study ID Numbers: PP-01-2014
• First Posted: October 29, 2014
• 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:

Urinary Incontinence; Enuresis; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Mental Disorders