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Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

Primary Purpose

Urinary Incontinence

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Conveen Optima is a urisheath to be used together with a collecting bag for urine
absorbent protection
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Conveen optima urisheaths

    absorbent protections

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Impact on quality of life

    Secondary Outcome Measures

    Efficacy (leakages)

    Full Information

    First Posted
    January 25, 2010
    Last Updated
    September 16, 2011
    Sponsor
    Coloplast A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01056666
    Brief Title
    Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2007 (undefined)
    Primary Completion Date
    February 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Coloplast A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conveen optima urisheaths
    Arm Type
    Experimental
    Arm Title
    absorbent protections
    Arm Type
    Placebo Comparator
    Arm Description
    The patient use their usual absorbent protection as comparator. All brands are allowed.
    Intervention Type
    Device
    Intervention Name(s)
    Conveen Optima is a urisheath to be used together with a collecting bag for urine
    Intervention Description
    Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis
    Intervention Type
    Device
    Intervention Name(s)
    absorbent protection
    Intervention Description
    The patient use his usual absorbent protection (same brand), and change it when needed
    Primary Outcome Measure Information:
    Title
    Impact on quality of life
    Time Frame
    Days 0, 15, 30
    Secondary Outcome Measure Information:
    Title
    Efficacy (leakages)
    Time Frame
    days 13, 14, 15 and days 28, 29, 30

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pierre Costa, Professor
    Organizational Affiliation
    Hôpital Caremeau Nimes. France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

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