Quality of Life Intermittent Catheter Study

Neurogenic Bladder Dysfunction Nos Clinical Trial

Official title:

Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523743
• Other study ID #: CP220
• Status: Completed
• Phase: Phase 4
• First received: January 9, 2012
• Last updated: April 28, 2014
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: April 2014
• Source: Coloplast A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesDenmark: Ethics CommitteeNorway: Ethics CommitteeSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Neurogenic Bladder Dysfunction Nos
• Urinary Bladder, Neurogenic

Intervention

Device:
• SpeediCath Compact
The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
• Standard care
The coated intermittent catheter normally used by subject

Locations

Country	Name	City	State
Denmark	PrivatHospitalet Danmark, privat hospital,	Charlottenlund
Denmark	Rigshospitalet, Urology clinic,	Copenhagen
Denmark	CCBR Vejle, Clinical research site,	Vejle
France	Hôpital Raymond Poincaré, Urology clinic	Garches
France	Hôpital Léon Berard, Rehabilitation clinic,	Hyères cedex
France	Hôpital Tenon, Neuro-Urology and perineal explorations department,	Paris	Cedex 20
France	Hôpital Henry Gabrielle, Urology clinic,	Saint Genis Laval
Germany	University Heidelberg, Neuro-Urology clinic,	Heidelberg
Norway	St. Olavs Hospital HF, Neurologi clinic,	Trondheim
Sweden	Gävle sjukhus, Urology clinic,	Gävle
Sweden	Rehab Station Stockholm,	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Coloplast A/S

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (0-100 Point)	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.	6 weeks	No