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Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

NCT01056666 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2011-09-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Pierre Costa, Professor · Hôpital Caremeau Nimes. France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-02-28
Completion
2009-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01056666 on ClinicalTrials.gov