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

NCT ID: NCT01837628

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lidocaine gel

Intraurethral Lidocaine gel 2%

Group Type ACTIVE_COMPARATOR

Lidocaine Gel

Intervention Type DRUG

Paraffin Oil

Intraurethral injection

Group Type EXPERIMENTAL

Paraffin Oil

Intervention Type DRUG

Interventions

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Lidocaine Gel

Intervention Type DRUG

Paraffin Oil

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All men who will be referred for urodynamic test

Exclusion Criteria

* Active infection
* Permanent Catheter
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofe MC

Locations

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Assaf Harofe Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kobi Stav, MD

Role: CONTACT

Facility Contacts

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Kobi Stav, MD

Role: primary

Other Identifiers

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7/13

Identifier Type: -

Identifier Source: org_study_id

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