Status:
COMPLETED
Quality of Life Intermittent Catheter Study
Lead Sponsor:
Coloplast A/S
Conditions:
Neurogenic Bladder Dysfunction Nos
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01523743
Start Date
November 1 2011
End Date
May 1 2012
Last Update
September 30 2016
Active Locations (11)
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1
PrivatHospitalet Danmark, privat hospital,
Charlottenlund, Denmark
2
Rigshospitalet, Urology clinic,
Copenhagen, Denmark
3
CCBR Vejle, Clinical research site,
Vejle, Denmark
4
Hôpital Tenon, Neuro-Urology and perineal explorations department,
Paris, Cedex 20, France