Study Where Healthy Volunteers Evaluate LoFric Catheters
A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 4, 2008
CompletedFirst Posted
Study publicly available on registry
December 5, 2008
CompletedFebruary 5, 2021
February 1, 2021
1 month
December 4, 2008
February 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Healthy volunteers perception of catheterization
At each catheterization (three times during one day)
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Healthy volunteers
- Males age 18 years and over
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research and Trial Centre, Lund University Hospital
Lund, SE-221 85, Sweden
Study Officials
- PRINCIPAL INVESTIGATOR
Ulf Malmqvist, MD, PhD, Assoc.Prof.
Clinical Research and Trial Centre, Lund University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2008
First Posted
December 5, 2008
Study Start
November 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
February 5, 2021
Record last verified: 2021-02