Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056666
• Other study ID #: FR002CC
• Status: Completed
• Phase: Phase 4
• First received: January 25, 2010
• Last updated: September 16, 2011
• Start date: June 2007
• Est. completion date: March 2009

Study information

• Verified date: April 2007
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Device:
• Conveen Optima is a urisheath to be used together with a collecting bag for urine
Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis
• absorbent protection
The patient use his usual absorbent protection (same brand), and change it when needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on quality of life		Days 0, 15, 30	No
Secondary	Efficacy (leakages)		days 13, 14, 15 and days 28, 29, 30	No