Catheterization
Conditions
Brief summary
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day. The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
Interventions
DEVICELoFric POBE
LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter LoFric POBE, Nelaton 40 cm, CH 12 with current solvent before being catheterized with the test catheters.
Sponsors
Wellspect HealthCare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Provision of written informed consent * Healthy volunteers * Males age 18 years and over
Exclusion criteria
* Known or suspected, current impairment of and/or decreased urethral sensibility * History of urethral disease * History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection * Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone) * Current drug, alcohol or other substance abuse * Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation * Allergy to Trimethoprim * Suspected poor compliance with the protocol during the complete study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healthy volunteers perception of catheterization | At each catheterization (three times during one day) |
Countries
Sweden
Outcome results
None listed