Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

NCT ID: NCT01056666

Last Updated: 2011-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-03-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conveen optima urisheaths

Group Type: EXPERIMENTAL

Conveen Optima is a urisheath to be used together with a collecting bag for urine

Intervention Type: DEVICE

Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis

absorbent protections

The patient use their usual absorbent protection as comparator. All brands are allowed.

Group Type: PLACEBO_COMPARATOR

absorbent protection

Intervention Type: DEVICE

The patient use his usual absorbent protection (same brand), and change it when needed

Interventions

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

Intervention Type: DEVICE

absorbent protection

The patient use his usual absorbent protection (same brand), and change it when needed

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Coloplast A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Costa, Professor

Role: PRINCIPAL_INVESTIGATOR

Hôpital Caremeau Nimes. France

Other Identifiers

FR002CC

Identifier Type: -

Identifier Source: org_study_id