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

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01066117
• Other study ID #: 5481
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2010
• Last updated: February 9, 2010
• Start date: February 2010
• Est. completion date: May 2010

Study information

• Verified date: February 2010
• Source: Tisteron Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Other:
• 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

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Tisteron Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pad weight and number of pads used per day		daily	No
Secondary	Observation for any development of rash due to patients' sensitivity to the pad		two weeks	Yes