Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence
|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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence||Other: PeeRelease gel absorbent pad||Not Applicable|
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|
- 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
- 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 ]
- Pad weight and number of pads used per day [ Time Frame: daily ]
- Observation for any development of rash due to patients' sensitivity to the pad [ Time Frame: two weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01066117
|Rabin Medical Center||Not yet recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Bari Kaplan, MD 97235355828 email@example.com|
|Principal Investigator: Bari Kaplan, MD|