Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
Evaluation de l'Impact Sur la qualité de Vie de l'Utilisation d'un système Collecteur Conveen( étuis pénien Conveen Optima Avec Poches de Recueil Conveen) Chez Des Hommes Souffrant d'Une Incontinence Urinaire modérée ou sévère, Comparativement à Leur Protection Absorbante Habituelle
1 other identifier
interventional
61
0 countries
N/A
Brief Summary
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual absorbent protection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2007
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
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 26, 2010
CompletedSeptember 19, 2011
April 1, 2007
1.7 years
January 25, 2010
September 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Impact on quality of life
Days 0, 15, 30
Secondary Outcomes (1)
Efficacy (leakages)
days 13, 14, 15 and days 28, 29, 30
Study Arms (2)
Conveen optima urisheaths
EXPERIMENTALabsorbent protections
PLACEBO COMPARATORThe patient use their usual absorbent protection as comparator. All brands are allowed.
Interventions
Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis
The patient use his usual absorbent protection (same brand), and change it when needed
Eligibility Criteria
You may qualify if:
- Patient over 18
- Out clinic patient
- Patient using absorbent protection for his urinary incontinence
- Moderate to severe urinary incontinence (1 hour pad test \> 10g)
- All kind of stable urinary incontinence
- Patient able to apply himself the device
- Patient able to understand the questions
- Patient having given his informed consent
- Patient whose overall treatment for his urinary incontinence is not modified during the study
You may not qualify if:
- Patient having a retracted penis
- Patient having skin problem on the penis
- Patient using urisheaths
- Bedridden patient
- Institutionalized patient
- Patient with indwelling catheter or under intermittent catheterisation
- Patient with fecal incontinence leading to the use of absorbent protection
- Patient suffering of urinary tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre Costa, Professor
Hôpital Caremeau Nimes. France
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 26, 2010
Study Start
June 1, 2007
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
September 19, 2011
Record last verified: 2007-04