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NCT00802750 Clinical Trial

Study Where Healthy Volunteers Evaluate LoFric Catheters

Catheterization Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00802750
Other study ID # YA-LSM-0001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2008
Est. completion date December 2008

Study information
Verified date February 2021
Source Wellspect HealthCare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
Sweden Clinical Research and Trial Centre, Lund University Hospital Lund

Sponsors (1)
Lead Sponsor Collaborator
Wellspect HealthCare

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Healthy volunteers perception of catheterization At each catheterization (three times during one day)
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