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

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
PeeRelease gel absorbent pad
Sponsored by
Tisteron Ltd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Urinary Incontinence focused on measuring urinary incontinent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Rabin Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pad weight and number of pads used per day
Observation for any development of rash due to patients' sensitivity to the pad

Full Information

First Posted
February 4, 2010
Last Updated
February 9, 2010
Sponsor
Tisteron Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01066117
Brief Title
Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence
Official Title
Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tisteron Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
urinary incontinent

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
PeeRelease gel absorbent pad
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
Pad weight and number of pads used per day
Time Frame
daily
Title
Observation for any development of rash due to patients' sensitivity to the pad
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Urinary incontinent women and men who loose urine at a quantity higher than drops (50CC or more). 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: Urinary incontinent disabled patients who need nursing Patients who presently have cancer of any kind,
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bari Kaplan, MD
Phone
97235355828
Email
prof@barikaplan.com
First Name & Middle Initial & Last Name & Degree
Bari Kaplan, MD

12. IPD Sharing Statement

Learn more about this trial

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

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