Urinary IncontinenceNCT01066117
Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence
A study testing PeeRelease gel absorbent pad in people with Urinary Incontinence, run by Tisteron Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PeeRelease gel absorbent pad
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Urinary incontinent disabled patients who need nursing
- Patients who presently have cancer of any kind,
Trial locations and contacts
1 site in 1 country.
Israel1 site
Rabin Medical Center
Petah Tikva, 49100
Bari Kaplan, MD, 97235355828, prof@barikaplan.com
Bari Kaplan, MD
About this study
Official title: Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions
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.
Read the 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.
- Conditions
- Urinary Incontinence
- Being tested
- PeeRelease gel absorbent pad
- Keywords
- urinary incontinent
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeeRelease gel absorbent padOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: two weeks
Secondary outcomes (2)
Pad weight and number of pads used per day
Measured: daily
Observation for any development of rash due to patients' sensitivity to the pad
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tisteron Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01066117
- Sponsor's protocol ID
- 5481
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 10 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of PeeRelease - a Gel Absorbent Pad in Moderate to Severe Urinary Incontinence Over Existing Solutions
- ClinicalTrials.gov ID
- NCT01066117
- Acronym / sponsor ID
- 5481
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tisteron Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 10 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (2 listed)
- Urinary incontinent disabled patients who need nursing
- Patients who presently have cancer of any kind,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeeRelease gel absorbent padA 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 | Other | – |
Primary outcome
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
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeeRelease gel absorbent pad in people with Urinary Incontinence, run by Tisteron Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2010.