Study Where Healthy Volunteers Evaluate LoFric Catheters
Not Applicable
Completed
- Conditions
- Catheterization
- Interventions
- Device: LoFric POBE
- Registration Number
- NCT00802750
- Lead Sponsor
- Wellspect HealthCare
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 25
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description B LoFric POBE - A LoFric POBE -
- Primary Outcome Measures
Name Time Method Healthy volunteers perception of catheterization At each catheterization (three times during one day)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research and Trial Centre, Lund University Hospital
🇸🇪Lund, Sweden