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Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01837628
Recruitment Status : Unknown
Verified April 2013 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Brief Summary:
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.

Condition or disease Intervention/treatment Phase
Pain Drug: Lidocaine Gel Drug: Paraffin Oil Not Applicable

Detailed Description:
Patients will be randomized into two groups: 1) Lidocaine Gel 2) Paraffin Oil. They will fill out 1 visual analogue scale (0-10) for urethral pain during the test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
Study Start Date : February 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : January 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine gel
Intraurethral Lidocaine gel 2%
Drug: Lidocaine Gel
Experimental: Paraffin Oil
Intraurethral injection
Drug: Paraffin Oil



Primary Outcome Measures :
  1. Visual Analogue scale (0-10) for pain [ Time Frame: up to 1 hour after the procedure ]
    patients will fill ou the scale before, during and immediately after the test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All men who will be referred for urodynamic test

Exclusion Criteria:

  • Active infection
  • Permanent Catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837628


Contacts
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Contact: Kobi Stav, MD stavkobi@gmail.com

Locations
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Israel
Assaf Harofe Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Kobi Stav, MD       stavkobi@gmail.com   
Principal Investigator: Kobi Stav, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Kobi Stav, MD Assaf Harofe MC

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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01837628    
Other Study ID Numbers: 7/13
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013
Keywords provided by Assaf-Harofeh Medical Center:
Urodynamic
Paraffin oil
Lidocaine gel
Pain
Additional relevant MeSH terms:
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Lidocaine
Mineral Oil
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents