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Completed

NCT Number: NCT00802750

Study Where Healthy Volunteers Evaluate LoFric Catheters

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.

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Key information

Conditions

Catheterization

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research and Trial Centre, Lund University Hospital

Lund, SE-221 85, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LoFric POBE

Device

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.

Primary outcomes

  1. Healthy volunteers perception of catheterization

    Time frame: At each catheterization (three times during one day)

Sponsors and collaborators

Lead sponsor

Wellspect HealthCare

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 5, 2008
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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