Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

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.

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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 protection

Device

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

Primary outcomes

Impact on quality of life

Time frame: Days 0, 15, 30

Secondary outcomes

Efficacy (leakages)

Time frame: days 13, 14, 15 and days 28, 29, 30

Sponsors and collaborators

Lead sponsor

Coloplast A/S

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Jan 26, 2010
Registry last updated: Sep 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed