Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence

February 9, 2010 updated by: Tisteron Ltd.

Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions

The purpose of the proposed study is to test the effect of the new gel pad on the quality of life of urinary incontinent men and women and to assess to what extent the gel pad improves the quality of life of incontinence persons.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The devices available today on the market serve two polar incontinence conditions: those who have severe urinary incontinence and need to use diapers several times per day, or those who have mild urinary incontinence and can use pads.

Such circumstances call for a search of new solution that may provide the benefit of freeing those with moderate incontinence from changing pads several times a day or staying constantly very near a bathroom, as well as freeing those with severe incontinence from using cumbersome diapers.

A larger gel containing pad was developed, suitable to absorb up to half a litter liquid, it eliminates odors and enables the users to wear ordinary clothes . It was presented for clinical trial.

The objectives of the clinical trial, proposed hereafter is to assess to what extent the new gel pad presents an advantage over the existing means of coping with urinary incontinence in cases when medicinal treatment or surgery is not appropriate.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Urinary incontinent women and men who loose urine at a quantity higher than drops (50CC or more).

  2. Three segments of such persons will be included in the study:

    • pregnant women who are temporary urinary incontinent
    • women of the age 40+ who are urinary incontinent
    • men who are urinary incontinent (post prostatectomy)

Exclusion Criteria:

  1. Urinary incontinent disabled patients who need nursing
  2. Patients who presently have cancer of any kind,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant improvement in quality of life for men and women who use the new gel pad in comparison to usage of existing solutions; this means a difference of at least 5 scores on the 1-100 I-QoL score scale
Time Frame: two weeks
two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pad weight and number of pads used per day
Time Frame: daily
daily
Observation for any development of rash due to patients' sensitivity to the pad
Time Frame: two weeks
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tisteron Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Anticipated)

May 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2010

Last Update Submitted That Met QC Criteria

February 9, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5481

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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