Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence
Recruitment status was Not yet recruiting
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions|
- 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 ] [ Designated as safety issue: No ]
- Pad weight and number of pads used per day [ Time Frame: daily ] [ Designated as safety issue: No ]
- Observation for any development of rash due to patients' sensitivity to the pad [ Time Frame: two weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Other: PeeRelease gel absorbent pad
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066117
|Rabin Medical Center||Not yet recruiting|
|Petah Tikva, Israel, 49100|
|Contact: Bari Kaplan, MD 97235355828 email@example.com|
|Principal Investigator: Bari Kaplan, MD|