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NCT01837628 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01837628
Other study ID # 7/13
Secondary ID
Status Recruiting
Phase N/A
First received April 18, 2013
Last updated April 22, 2013
Start date February 2013
Est. completion date January 2014

Study information
Verified date April 2013
Source Assaf-Harofeh Medical Center
Contact Kobi Stav, MD
Email stavkobi@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All men who will be referred for urodynamic test

Exclusion Criteria:

- Active infection

- Permanent Catheter

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lidocaine Gel

• Paraffin Oil

Locations
Country Name City State
Israel Assaf Harofe Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Analogue scale (0-10) for pain patients will fill ou the scale before, during and immediately after the test up to 1 hour after the procedure No
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