Study Where Healthy Volunteers Evaluate LoFric Catheters
NCT ID: NCT00802750
Last Updated: 2021-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2008-11-30
2008-12-31
Brief Summary
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The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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A
LoFric 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.
B
LoFric POBE
Unsalted LoFric POBE Hydro-Kit II, 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.
Interventions
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LoFric 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.
LoFric POBE
Unsalted LoFric POBE Hydro-Kit II, 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.
Eligibility Criteria
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Inclusion Criteria
* Healthy volunteers
* Males age 18 years and over
Exclusion Criteria
* 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.
18 Years
MALE
Yes
Sponsors
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Wellspect HealthCare
INDUSTRY
Responsible Party
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Principal Investigators
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Ulf Malmqvist, MD, PhD, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Clinical Research and Trial Centre, Lund University Hospital
Locations
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Clinical Research and Trial Centre, Lund University Hospital
Lund, , Sweden
Countries
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Other Identifiers
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YA-LSM-0001
Identifier Type: -
Identifier Source: org_study_id
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