NCT01066117

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 10, 2010

Status Verified

February 1, 2010

Enrollment Period

3 months

First QC Date

February 4, 2010

Last Update Submit

February 9, 2010

Conditions

Urinary Incontinence

Keywords

urinary incontinent

Outcome Measures

Primary Outcomes (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

    two weeks

Secondary Outcomes (2)

  • Pad weight and number of pads used per day

    daily

  • Observation for any development of rash due to patients' sensitivity to the pad

    two weeks

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Urinary incontinent disabled patients who need nursing
  • Patients who presently have cancer of any kind,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 4, 2010

First Posted

February 10, 2010

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 10, 2010

Record last verified: 2010-02

Locations

IL(1)