Quality of Life Intermittent Catheter Study

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

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.

Study Overview

• Status: Completed
• Conditions: Neurogenic Bladder Dysfunction Nos
• Intervention / Treatment: Device: SpeediCath Compact; Device: Standard care

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Charlottenlund, Denmark
    • PrivatHospitalet Danmark, privat hospital,
  • Copenhagen, Denmark
    • Rigshospitalet, Urology clinic,
  • Vejle, Denmark
    • CCBR Vejle, Clinical research site,
• France
  • Garches, France, 92350
    • Hôpital Raymond Poincaré, Urology clinic
  • Hyères cedex, France
    • Hôpital Léon Berard, Rehabilitation clinic,
  • Saint Genis Laval, France
    • Hôpital Henry Gabrielle, Urology clinic,
  • Cedex 20
    • Paris, Cedex 20, France
      • Hôpital Tenon, Neuro-Urology and perineal explorations department,
• Germany
  • Heidelberg, Germany
    • University Heidelberg, Neuro-Urology clinic,
• Norway
  • Trondheim, Norway
    • St. Olavs Hospital HF, Neurologi clinic,
• Sweden
  • Gävle, Sweden
    • Gävle sjukhus, Urology clinic,
  • Stockholm, Sweden
    • Rehab Station Stockholm,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Coloplast A/S
• Investigators: Principal Investigator: Emmanuel Chartier-Kastler, Proff, Hôpital Raymond poincarè, Service d'Urologie, Garches, France

Publications and helpful links

General Publications

• Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: January 30, 2012
• First Posted (Estimate): February 1, 2012

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Urinary Bladder, Neurogenic
• Other Study ID Numbers: CP220