Status:
COMPLETED
A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.
Lead Sponsor:
Wellspect HealthCare
Conditions:
Urinary Catheterization
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting so...
Detailed Description
The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers. All subjects will first be catheterized with a reference catheter, which is proven to...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Healthy volunteer
- Male aged 18 years or over
Exclusion
- Known or suspected, current impairment of and/or decreased urethral sensibility
- History of urethral morbidity
- History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
- Use of medications that may affect the urethra´s dryness (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 antibiotics suspected poor compliance with the protocol during the complete study period
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00748033
Start Date
August 1 2008
End Date
August 1 2008
Last Update
May 6 2021
Active Locations (1)
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1
Karolinska Trial Alliance A2:01, Karolinska University Hospital
Stockholm, Sweden, SE-171 76