A Study Evaluating a Urinary Catheter With Different Activation Times for the Wetting Solution, in Healthy Male Volunteers.

Wellspect HealthCare

Status: Completed

Conditions: Urinary Catheterization

Treatments: Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12; Device: LoFric POBE Hydro-Kit II, 5 seconds; Device: LoFric POBE Hydro-Kit II, 24 hours

Study type: Interventional

Funder types: Industry

Identifiers

NCT00748033

YA-CLO-0005

Details and patient eligibility

About

The primary purpose of this study is to compare the subject's perception (separately for each randomized catheter) of practicing catheterization when using catheters with sodium chloride in wetting solution (using two different activation times) with a standard reference catheter. The hypothesis is that the subjects' perception of catheterization is the same or more positive when using the test catheters compared to the reference catheter.

Full description

The study is designed as a randomized, single-blind, cross-over, single-centre, study in healthy male volunteers.

All subjects will first be catheterized with a reference catheter, which is proven to be well tolerated by most subjects. This catheter will be used as a reference catheter to be compared with the randomized catheters. One more reason for this first test is to withdraw subjects who cannot tolerate catheterizations. Subjects will qualify for the randomized part of the study only if the first catheterization could be performed without significant discomfort.

When the subject is randomized he will be catheterized with two urinary catheters in a randomized order during one day. The activation times for the wetting solution will be 5 seconds and 24 (± 2h) hours.

During each catheterization, the friction at withdrawal will be measured for the catheter using a Tension Test System.

The subjects will be blinded. 25 healthy volunteers will be recruited from a single centre in Sweden.

Enrollment: 25 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of written informed consent
• Healthy volunteer
• Male aged 18 years or over

Exclusion criteria

• Known or suspected, current impairment of and/or decreased urethral sensibility
• History of urethral morbidity
• History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
• Use of medications that may affect the urethra´s dryness (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 antibiotics suspected poor compliance with the protocol during the complete study period

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

LoFric POBE Hydro-Kit II, 5 seconds and then LoFric POBE Hydro-Kit II, 24 hours

Experimental group

Description:

All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 5 seconds. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 24 hours.

Treatment:

Device: LoFric POBE Hydro-Kit II, 24 hours

Device: LoFric POBE Hydro-Kit II, 5 seconds

Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12

LoFric POBE Hydro-Kit II, 24 hours and then LoFric POBE Hydro-Kit II, 5 seconds

Experimental group

Description:

All subjects were first catheterizised with the reference catheter. After randomisation this group was first catheterizised with LoFric POBE Hydro-Kit II, activation time 24 hours. Then the next test catheter was used LoFric POBE Hydro-Kit II, activation time 5 seconds.

Treatment:

Device: LoFric POBE Hydro-Kit II, 24 hours

Device: LoFric POBE Hydro-Kit II, 5 seconds

Device: Reference catheter: LoFric PVC, Nelaton 40 cm, CH 12