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

NCT00748033 | Completed Results

• 1 other identifier: YA-CLO-0005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Catheterization

Outcome Measures

Primary Outcomes (4)

• Subjects' Perception at Insertion of Test Catheter Activated for 5 Seconds, Compared to Reference.

  The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Subjects' Perception at Insertion of Test Catheter Activated for 24 Hours, Compared to Reference.

  The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding insertion?'.

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Subjects' Perception at Withdrawal of Test Catheter Activated for 5 Seconds, Compared to Reference.

  The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Subjects' Perception at Withdrawal of Test Catheter Activated for 24 Hours, Compared to Reference.

  The assessment was made in relation to the reference catheter, and the question to the subject was 'How do you experience this procedure/catheterization in comparison with the baseline procedure/catheterization regarding withdrawal?'.

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

Secondary Outcomes (9)

• Comparison of the Perception at Insertion Between 5s and 24h Activation Times. Times

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Comparison of the Perception at Withdrawal Between 5s and 24h Activation Times.

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Test of Carry-over Effect at Insertion, Mean Rating of Perception on a Scale of 0 to 5

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Test of Carry-over Effect at Withdrawal, Mean Rating of Perception on a Scale of 0 to 5

  A minimum of two hours elapsed between the catheterizations and each catherization lasted for 3 minutes. The subjects were catheterized three times during one day.

• Tension Test System: Ref-24h Mean

  The Tension test system was performed while withdrawing the catheters up to 5 seconds.

Study Arms (2)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

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

The subjects were first catheterized with this reference catheter.

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (1)

Karolinska Trial Alliance A2:01, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Location

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Wellspect Health Care

mace@wellspect.com

+46313763000

Study Officials

• Magnus Jacobsson, MD, PhD, Prof.

  Dentsply Sirona Implants and Consumables

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two different activation times for the wetting solution for a urinary catheter will be used in healthy volunteers, compared to the use of a registered urinary catheter.

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 6, 2021
• Results First Posted: May 6, 2021

Record last verified: 2021-04

Locations

SE (1)