NCT01523743

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

May 22, 2014

Completed
Last Updated

September 30, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

January 9, 2012

Results QC Date

August 6, 2013

Last Update Submit

August 23, 2016

Conditions

Neurogenic Bladder Dysfunction Nos

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Compact catheter

EXPERIMENTAL

Compact intermittent catheter

Device: SpeediCath Compact

Standard Care

ACTIVE COMPARATOR

Standard Care: Coated intermittent catheter normally used by subject

Device: Standard care

Interventions

SpeediCath CompactDEVICE

The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.

Also known as: SpeediCath®Compact Male, for male participants, SpeediCath®Compact Female, for female participants
Compact catheter
Standard careDEVICE

The coated intermittent catheter normally used by subject

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

PrivatHospitalet Danmark, privat hospital,

Charlottenlund, Denmark

Location

Rigshospitalet, Urology clinic,

Copenhagen, Denmark

Location

CCBR Vejle, Clinical research site,

Vejle, Denmark

Location

Hôpital Tenon, Neuro-Urology and perineal explorations department,

Paris, Cedex 20, France

Location

Hôpital Raymond Poincaré, Urology clinic

Garches, 92350, France

Location

Hôpital Léon Berard, Rehabilitation clinic,

Hyères, France

Location

Hôpital Henry Gabrielle, Urology clinic,

Saint-Genis-Laval, France

Location

University Heidelberg, Neuro-Urology clinic,

Heidelberg, Germany

Location

St. Olavs Hospital HF, Neurologi clinic,

Trondheim, Norway

Location

Gävle sjukhus, Urology clinic,

Gävle, Sweden

Location

Rehab Station Stockholm,

Stockholm, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 34699062DERIVED

Results Point of Contact

Title
Pref. Emmanuel Chartier-kastler
Organization
Hopital Raymond poincare
emmanuel.chartier-kastler@psl.aphp.fr
+33 1 42 17 71 29

Study Officials

  • Emmanuel Chartier-Kastler, Proff

    Hôpital Raymond poincarè, Service d'Urologie, Garches, France

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

February 1, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

September 30, 2016

Results First Posted

May 22, 2014

Record last verified: 2016-08

Locations

FR(4)SE(2)DK(3)NO(1)DE(1)