Conveen Optima Urisheaths With Collecting Bags Versus Abs... | NCT01056666

Studies
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents

NCT01056666

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

Sep 19, 2011Estimated

Enrollment

61Actual

Phase

Phase 4

Conditions

Urinary Incontinence

Interventions

Conveen Optima is a urisheath to be used together with a collecting bag for urine
absorbent protection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Apr 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Feb 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jan 25, 2010

First Submission Date that Met QC Criteria

Jan 25, 2010

First Posted Date

Jan 26, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2011

Last Update Posted Date

Sep 19, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conveen optima urisheaths	Experimental		Device: Conveen Optima is a urisheath to be used together with a collecting bag for urine
absorbent protections	Placebo Comparator	The patient use their usual absorbent protection as comparator. All brands are allowed.	Device: absorbent protection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conveen Optima is a urisheath to be used together with a collecting bag for urine	Device	Conveen optima urisheath is intended to be used together with a collecting bag for urine and to be changed on a daily basis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact on quality of life		Days 0, 15, 30

Secondary Outcomes

Measure	Description	Time Frame
Efficacy (leakages)		days 13, 14, 15 and days 28, 29, 30

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre Costa, Professor	Hôpital Caremeau Nimes. France	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014549	Urinary Incontinence

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided