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Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01056666
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : September 19, 2011
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine Device: absorbent protection Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2007
Primary Completion Date : February 2009
Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Conveen optima urisheaths 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
Placebo Comparator: absorbent protections
The patient use their usual absorbent protection as comparator. All brands are allowed.
Device: absorbent protection
The patient use his usual absorbent protection (same brand), and change it when needed

Primary Outcome Measures :
  1. Impact on quality of life [ Time Frame: Days 0, 15, 30 ]

Secondary Outcome Measures :
  1. Efficacy (leakages) [ Time Frame: days 13, 14, 15 and days 28, 29, 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056666

Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Pierre Costa, Professor Hôpital Caremeau Nimes. France

Responsible Party: Coloplast A/S Identifier: NCT01056666     History of Changes
Other Study ID Numbers: FR002CC
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: September 19, 2011
Last Verified: April 2007

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders