Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Phase 4

Completed

• Conditions: Urinary Incontinence
• Interventions: Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine; Device: absorbent protection

• Registration Number: NCT01056666
• Lead Sponsor: Coloplast A/S

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-04
• Study Start: 2007-06
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Study First Submitted: 2010-01-25
• Study First Submitted QC: 2010-01-25
• Study First Posted: 2010-01-26
• Last Update Submitted: 2011-09-16
• Last Update Posted: 2011-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conveen optima urisheaths	Conveen Optima is a urisheath to be used together with a collecting bag for urine	-
absorbent protections	absorbent protection	The patient use their usual absorbent protection as comparator. All brands are allowed.

Primary Outcome Measures

Name	Time	Method
Impact on quality of life	Days 0, 15, 30

Secondary Outcome Measures

Name	Time	Method
Efficacy (leakages)	days 13, 14, 15 and days 28, 29, 30