MedTrace Logo

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

NCT00748033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-05-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Urinary Catheterization

Interventions

DEVICE

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

The subjects were first catheterized with this reference catheter.

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

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

Sponsors & Collaborators

  • Wellspect HealthCare

    lead INDUSTRY

Principal Investigators

  • Magnus Jacobsson, MD, PhD, Prof. · Dentsply Sirona Implants and Consumables

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748033 on ClinicalTrials.gov