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

Not Applicable

• Conditions: Urinary Incontinence

• Registration Number: NCT01066117
• Lead Sponsor: Tisteron Ltd.

Brief Summary

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.

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 Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-09
• Last Update Submitted: 2010-02-09
• Study First Posted: 2010-02-10
• Last Update Posted: 2010-02-10
• Primary Completion: 2010-05
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	two weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel