N/A
N=41
Test of Discomfort and Malaise of Two Different Urine Catheters in Healthy Volunteers
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT01142115 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Discomfort Measured on the Visual Analog Scale (VAS) — 3.7; 2.6 cm — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent catheter CP063CC (Device); SpeediCath (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Discomfort Measured on the Visual Analog Scale (VAS) |
3.7; 2.6 | 0.0018 sig |
| SECONDARY Irritation During Voiding After Catheterization |
21; 7; 17; 32 | <0.0001 sig |
| SECONDARY Ease of Use Measured on a 5 Point Scale: Insertion Effort |
2; 7; 16; 20; 13; 8 | 0.6160 |
| SECONDARY Ease of Use Measured on a 5 Point Scale: Withdrawal Effort |
28; 28; 10; 11; 0; 0 | 0.8014 |
| SECONDARY Visible Blood |
3; 1; 35; 38 | 0.3085 |
| SECONDARY Haematuria |
10; 9; 28; 30 | 0.4324 |
Summary
The purpose of this study is to evaluate the safety of a new developed catheter in comparison with an catheter on the market. The study is randomised.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Male
- signed informed Consent,
- Neg. urine multistix
Exclusion Criteria
- Abnormalities,
- diseases or surgical procedures performed in the lower urinary-tract
Data sourced from ClinicalTrials.gov (NCT01142115). 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.