- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01837628
Reducing Urethral Pain During Urodynamic Test - Comparison Between Lidocaine Gel and Paraffin Oil
April 22, 2013 updated by: Assaf-Harofeh Medical Center
Our purpose is to compare between intraurethral lidocaine gel and paraffin oil in reducing urethral pain during urodynamic test.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kobi Stav, MD
- Email: stavkobi@gmail.com
Study Locations
-
-
-
Zerifin, Israel, 70300
- Recruiting
- Assaf Harofe Medical Center
-
Principal Investigator:
- Kobi Stav, MD
-
Contact:
- Kobi Stav, MD
- Email: stavkobi@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All men who will be referred for urodynamic test
Exclusion Criteria:
- Active infection
- Permanent Catheter
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lidocaine gel
Intraurethral Lidocaine gel 2%
|
|
Experimental: Paraffin Oil
Intraurethral injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 1 hour after the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kobi Stav, MD, Assaf Harofe MC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
January 1, 2014
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
April 18, 2013
First Submitted That Met QC Criteria
April 22, 2013
First Posted (Estimate)
April 23, 2013
Study Record Updates
Last Update Posted (Estimate)
April 23, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Dermatologic Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Emollients
- Lidocaine
- Mineral Oil
Other Study ID Numbers
- 7/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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