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

NCT ID: NCT00748033

Last Updated: 2021-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2008-08-31

Brief Summary

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.

Detailed 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.

Conditions

Urinary Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

The subjects were first catheterized with this reference catheter.

LoFric POBE Hydro-Kit II, 5 seconds

Intervention Type: DEVICE

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds

LoFric POBE Hydro-Kit II, 24 hours

Intervention Type: DEVICE

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

The subjects were first catheterized with this reference catheter.

LoFric POBE Hydro-Kit II, 5 seconds

Intervention Type: DEVICE

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds

LoFric POBE Hydro-Kit II, 24 hours

Intervention Type: DEVICE

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours

Interventions

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

The subjects were first catheterized with this reference catheter.

Intervention Type: DEVICE

LoFric POBE Hydro-Kit II, 5 seconds

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 5 seconds

Intervention Type: DEVICE

LoFric POBE Hydro-Kit II, 24 hours

An unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with sodium chloride in wetting solution, activation time 24 hours

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wellspect HealthCare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magnus Jacobsson, MD, PhD, Prof.

Role: STUDY_DIRECTOR

Dentsply Sirona Implants and Consumables

Locations

Karolinska Trial Alliance A2:01, Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

YA-CLO-0005

Identifier Type: -

Identifier Source: org_study_id