Quality of Life Intermittent Catheter Study

Phase 4

Completed

• Conditions: Neurogenic Bladder Dysfunction Nos
• Interventions: Device: SpeediCath Compact; Device: Standard care

• Registration Number: NCT01523743
• Lead Sponsor: Coloplast A/S

Brief Summary

The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-01-09
• Study First Submitted QC: 2012-01-30
• Study First Posted: 2012-02-01
• Primary Completion: 2012-04
• Study Completion: 2012-05
• Results First Submitted: 2013-08-06
• Results First Submitted QC: 2014-04-28
• Results First Posted: 2014-05-22
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• Is at least 18 years of age
• Has given written informed consent
• Has neurogenic bladder dysfunction
• Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months
• Is able to self-catheterise
• Is able to use SpeediCath® compact catheters
• If spinal cord injury subject, injury must have occurred more than 12 months ago
• Covered by Social security system

Exclusion Criteria

• Has used SpeediCath® compact catheters (not including screening for this investigation)
• Is admitted to rehabilitation centre
• Subjects using primarily catheter sets
• Is pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Compact catheter	SpeediCath Compact	Compact intermittent catheter
Standard Care	Standard care	Standard Care: Coated intermittent catheter normally used by subject

Primary Outcome Measures

Name	Time	Method
Quality of Life (0-100 Point)	6 weeks	Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life.

Trial Locations

Locations (11)

Rehab Station Stockholm,; 🇸🇪 Stockholm, Sweden

University Heidelberg, Neuro-Urology clinic,; 🇩🇪 Heidelberg, Germany

Hôpital Henry Gabrielle, Urology clinic,; 🇫🇷 Saint Genis Laval, France

Gävle sjukhus, Urology clinic,; 🇸🇪 Gävle, Sweden

Hôpital Léon Berard, Rehabilitation clinic,; 🇫🇷 Hyères cedex, France

CCBR Vejle, Clinical research site,; 🇩🇰 Vejle, Denmark

PrivatHospitalet Danmark, privat hospital,; 🇩🇰 Charlottenlund, Denmark

Rigshospitalet, Urology clinic,; 🇩🇰 Copenhagen, Denmark

Hôpital Raymond Poincaré, Urology clinic; 🇫🇷 Garches, France

Hôpital Tenon, Neuro-Urology and perineal explorations department,; 🇫🇷 Paris, Cedex 20, France

St. Olavs Hospital HF, Neurologi clinic,; 🇳🇴 Trondheim, Norway