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

NCT ID: NCT01066117

Last Updated: 2010-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-05-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

PeeRelease gel absorbent pad

A larger gel containing pad was developed, suitable to absorb up to half a liter liquid, it eliminates odors and enables the users to wear ordinary clothes

Intervention Type: OTHER

Eligibility Criteria

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tisteron Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Tisteron Ltd

Locations

Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Facility Contacts

Bari Kaplan, MD

Role: primary

prof@barikaplan.com

97235355828

Other Identifiers

5481

Identifier Type: -

Identifier Source: org_study_id