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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Catheterization

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)