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Quality of Life Intermittent Catheter Study

Primary Purpose

Neurogenic Bladder Dysfunction Nos

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
SpeediCath Compact
Standard care
Sponsored by
Coloplast A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neurogenic Bladder Dysfunction Nos

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PrivatHospitalet Danmark, privat hospital,
  • Rigshospitalet, Urology clinic,
  • CCBR Vejle, Clinical research site,
  • Hôpital Tenon, Neuro-Urology and perineal explorations department,
  • Hôpital Raymond Poincaré, Urology clinic
  • Hôpital Léon Berard, Rehabilitation clinic,
  • Hôpital Henry Gabrielle, Urology clinic,
  • University Heidelberg, Neuro-Urology clinic,
  • St. Olavs Hospital HF, Neurologi clinic,
  • Gävle sjukhus, Urology clinic,
  • Rehab Station Stockholm,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compact catheter

Standard Care

Arm Description

Compact intermittent catheter

Standard Care: Coated intermittent catheter normally used by subject

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2012
Last Updated
August 23, 2016
Sponsor
Coloplast A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01523743
Brief Title
Quality of Life Intermittent Catheter Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Coloplast A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder Dysfunction Nos

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compact catheter
Arm Type
Experimental
Arm Description
Compact intermittent catheter
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Standard Care: Coated intermittent catheter normally used by subject
Intervention Type
Device
Intervention Name(s)
SpeediCath Compact
Other Intervention Name(s)
SpeediCath®Compact Male, for male participants, SpeediCath®Compact Female, for female participants
Intervention Description
The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
Intervention Type
Device
Intervention Name(s)
Standard care
Intervention Description
The coated intermittent catheter normally used by subject
Primary Outcome Measure Information:
Title
Quality of Life (0-100 Point)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Chartier-Kastler, Proff
Organizational Affiliation
Hôpital Raymond poincarè, Service d'Urologie, Garches, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
PrivatHospitalet Danmark, privat hospital,
City
Charlottenlund
Country
Denmark
Facility Name
Rigshospitalet, Urology clinic,
City
Copenhagen
Country
Denmark
Facility Name
CCBR Vejle, Clinical research site,
City
Vejle
Country
Denmark
Facility Name
Hôpital Tenon, Neuro-Urology and perineal explorations department,
City
Paris
State/Province
Cedex 20
Country
France
Facility Name
Hôpital Raymond Poincaré, Urology clinic
City
Garches
ZIP/Postal Code
92350
Country
France
Facility Name
Hôpital Léon Berard, Rehabilitation clinic,
City
Hyères cedex
Country
France
Facility Name
Hôpital Henry Gabrielle, Urology clinic,
City
Saint Genis Laval
Country
France
Facility Name
University Heidelberg, Neuro-Urology clinic,
City
Heidelberg
Country
Germany
Facility Name
St. Olavs Hospital HF, Neurologi clinic,
City
Trondheim
Country
Norway
Facility Name
Gävle sjukhus, Urology clinic,
City
Gävle
Country
Sweden
Facility Name
Rehab Station Stockholm,
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34699062
Citation
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.
Results Reference
derived

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Quality of Life Intermittent Catheter Study

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