Phase 4
Completed N=125
Quality of Life Intermittent Catheter Study
Neurogenic Bladder Dysfunction Nos
Source: ClinicalTrials.gov NCT01523743 ↗
Enrolled (actual)
125
Serious AEs
2.1%
Results posted
May 2014
Primary outcomePrimary: Quality of Life (0-100 Point) — 76.8; 59.8 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quality of Life (0-100 Point) |
76.8; 59.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT01523743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.