Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01056666
First received: January 25, 2010
Last updated: September 16, 2011
Last verified: April 2007

January 25, 2010
September 16, 2011
June 2007
February 2009   (final data collection date for primary outcome measure)
Impact on quality of life [ Time Frame: Days 0, 15, 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01056666 on ClinicalTrials.gov Archive Site
Efficacy (leakages) [ Time Frame: days 13, 14, 15 and days 28, 29, 30 ] [ Designated as safety issue: No ]
Efficacy( leakages) [ Time Frame: days 13, 14, 15 and days 28, 29, 30 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Incontinence
  • 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
  • Device: absorbent protection
    The patient use his usual absorbent protection (same brand), and change it when needed
  • Experimental: Conveen optima urisheaths
    Intervention: Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine
  • Placebo Comparator: absorbent protections
    The patient use their usual absorbent protection as comparator. All brands are allowed.
    Intervention: Device: absorbent protection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
March 2009
February 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01056666
FR002CC
No
Coloplast A/S
Coloplast A/S
Not Provided
Principal Investigator: Pierre Costa, Professor Hôpital Caremeau Nimes. France
Coloplast A/S
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP