Quality of Life Intermittent Catheter Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S
ClinicalTrials.gov Identifier:
NCT01523743
First received: January 9, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Neurogenic Bladder Dysfunction Nos
Device: SpeediCath Compact
Device: Standard care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Further study details as provided by Coloplast A/S:

Primary Outcome Measures:
  • Quality of Life (0-100 Point) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 125
Study Start Date: November 2011
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compact catheter
Compact intermittent catheter
Device: SpeediCath Compact
The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
Other Names:
  • SpeediCath®Compact Male, for male participants
  • SpeediCath®Compact Female, for female participants
Active Comparator: Standard Care
Standard Care: Coated intermittent catheter normally used by subject
Device: Standard care
The coated intermittent catheter normally used by subject

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01523743

Locations
Denmark
PrivatHospitalet Danmark, privat hospital,
Charlottenlund, Denmark
Rigshospitalet, Urology clinic,
Copenhagen, Denmark
CCBR Vejle, Clinical research site,
Vejle, Denmark
France
Hôpital Tenon, Neuro-Urology and perineal explorations department,
Paris, Cedex 20, France
Hôpital Raymond Poincaré, Urology clinic
Garches, France, 92350
Hôpital Léon Berard, Rehabilitation clinic,
Hyères cedex, France
Hôpital Henry Gabrielle, Urology clinic,
Saint Genis Laval, France
Germany
University Heidelberg, Neuro-Urology clinic,
Heidelberg, Germany
Norway
St. Olavs Hospital HF, Neurologi clinic,
Trondheim, Norway
Sweden
Gävle sjukhus, Urology clinic,
Gävle, Sweden
Rehab Station Stockholm,
Stockholm, Sweden
Sponsors and Collaborators
Coloplast A/S
Investigators
Principal Investigator: Emmanuel Chartier-Kastler, Proff Hôpital Raymond poincarè, Service d'Urologie, Garches, France
  More Information

No publications provided

Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT01523743     History of Changes
Other Study ID Numbers: CP220
Study First Received: January 9, 2012
Results First Received: August 6, 2013
Last Updated: April 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Denmark: Ethics Committee
Norway: Ethics Committee
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014