Study Where Healthy Volunteers Evaluate LoFric Catheters

Wellspect HealthCare

Status: Completed

Conditions: Catheterization

Treatments: Device: LoFric POBE

Study type: Interventional

Funder types: Industry

Identifiers

NCT00802750

YA-LSM-0001

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

25 participants in 2 patient groups

A

Experimental group

Treatment:

Device: LoFric POBE

Device: LoFric POBE

B

Experimental group

Treatment:

Device: LoFric POBE

Device: LoFric POBE