N/A
N=36
Evaluation of Residual Urine After Intermittent Catheterisation
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00324233 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: Residual Urine Measured by Ultra Sound — 11; 6 ml — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intermittent catheter (Device); Compact intermittent catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Coloplast A/S
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Urine Measured by Ultra Sound |
11; 6 | 0.56 |
| SECONDARY Subjectively Measured Handling |
— | — |
| SECONDARY Subjectively Measured Insertion of the Catheter |
— | — |
Summary
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.
Eligibility Criteria
Inclusion Criteria
- Male
- 18 years and above
- A negative urine dip-stick
- Have signed informed written consent to participate
Exclusion Criteria
- The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract
Data sourced from ClinicalTrials.gov (NCT00324233). 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.