NCT01056666
Completed
Phase 4
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
ConditionsUrinary Incontinence
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- Coloplast A/S
- Enrollment
- 61
- Primary Endpoint
- Impact on quality of life
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Impact on quality of life
Time Frame: Days 0, 15, 30
Secondary Outcomes
- Efficacy (leakages)(days 13, 14, 15 and days 28, 29, 30)
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