Feasibility Study Evaluating the ParaPatch System

NCT ID: NCT02278146

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-02-29

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1) Stress urinary incontinence

Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System

Group Type: EXPERIMENTAL

ParaPatch

Intervention Type: DEVICE

A device for the treatment of urinary incontinence

2) Overactive bladder

Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System

Group Type: EXPERIMENTAL

ParaPatch

Intervention Type: DEVICE

A device for the treatment of urinary incontinence

Interventions

ParaPatch

A device for the treatment of urinary incontinence

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ParaPatch, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy Santa Cruz

Role: STUDY_DIRECTOR

Sponsor GmbH

Locations

Skyline Urology

Sherman Oaks, California, United States

Skyline Urology

Torrance, California, United States

Countries

United States

Other Identifiers

PP-01-2014

Identifier Type: -

Identifier Source: org_study_id