NCT01837628

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

11 months

First QC Date

April 18, 2013

Last Update Submit

April 22, 2013

Conditions

Pain

Keywords

UrodynamicParaffin oilLidocaine gelPain

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lidocaine gel

ACTIVE COMPARATOR

Intraurethral Lidocaine gel 2%

Drug: Lidocaine Gel

Paraffin Oil

EXPERIMENTAL

Intraurethral injection

Drug: Paraffin Oil

Interventions

Lidocaine GelDRUG
Lidocaine gel
Paraffin OilDRUG
Paraffin Oil

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All men who will be referred for urodynamic test

You may not qualify if:

  • Active infection
  • Permanent Catheter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe Medical Center

Ẕerifin, 70300, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Mineral Oil

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PetrolatumHydrocarbonsOrganic Chemicals

Study Officials

  • Kobi Stav, MD

    Assaf Harofe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

stavkobi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 23, 2013

Study Start

February 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

IL(1)