Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Coloplast

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Device: absorbent protection; Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01056666

FR002CC

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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61 participants in 2 patient groups, including a placebo group

Conveen optima urisheaths

Experimental group

Treatment:

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

absorbent protections

Placebo Comparator group

Description:

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

Treatment:

Device: absorbent protection