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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Impact on quality of life [ Time Frame: Days 0, 15, 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy (leakages) [ Time Frame: days 13, 14, 15 and days 28, 29, 30 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: June 2007
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056666

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

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01056666     History of Changes
Other Study ID Numbers: FR002CC
Study First Received: January 25, 2010
Last Updated: September 16, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Urinary Incontinence
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014