Status:
COMPLETED
Study Where Healthy Volunteers Evaluate LoFric Catheters
Lead Sponsor:
Wellspect HealthCare
Conditions:
Catheterization
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Healthy volunteers
- Males age 18 years and over
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00802750
Start Date
November 1 2008
End Date
December 1 2008
Last Update
February 5 2021
Active Locations (1)
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1
Clinical Research and Trial Centre, Lund University Hospital
Lund, Sweden, SE-221 85