Reducing Urethral Pain During Urodynamic Test - Compariso... | NCT01837628

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

NCT01837628

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Apr 23, 2013Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

Lidocaine Gel
Paraffin Oil

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Apr 22, 2013

First Posted Date

Apr 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2013

Last Update Posted Date

Apr 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine gel	Active Comparator	Intraurethral Lidocaine gel 2%	Drug: Lidocaine Gel
Paraffin Oil	Experimental	Intraurethral injection	Drug: Paraffin Oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine Gel	Drug		Lidocaine gel
Paraffin Oil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All men who will be referred for urodynamic test

Exclusion Criteria:

Active infection
Permanent Catheter

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kobi Stav, MD	Contact			stavkobi@gmail.com

Overall Officials

Name	Affiliation	Role
Kobi Stav, MD	Assaf Harofe MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofe Medical Center	Recruiting	Ẕerifin		70300	Israel

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008899	Mineral Oil

Ancestor Terms

ID	Term
D010577	Petrolatum
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided