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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01066117
Recruitment Status : Unknown
Verified February 2010 by Tisteron Ltd..
Recruitment status was:  Not yet recruiting
First Posted : February 10, 2010
Last Update Posted : February 10, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Urinary Incontinence Other: PeeRelease gel absorbent pad

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  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions
Study Start Date : February 2010
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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


Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pad weight and number of pads used per day [ Time Frame: daily ]
  2. Observation for any development of rash due to patients' sensitivity to the pad [ Time Frame: two weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066117


Locations
Israel
Rabin Medical Center Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Bari Kaplan, MD    97235355828    prof@barikaplan.com   
Principal Investigator: Bari Kaplan, MD         
Sponsors and Collaborators
Tisteron Ltd.

Responsible Party: Tisteron Ltd
ClinicalTrials.gov Identifier: NCT01066117     History of Changes
Other Study ID Numbers: 5481
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: February 10, 2010
Last Verified: February 2010

Keywords provided by Tisteron Ltd.:
urinary incontinent

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders