NCT01612156

Brief Summary

The purpose of this study is to determine a difference in patient reported pain levels before, during, and after multichannel urodynamics in patients treated with 2% lidocaine gel or water based lubricant. We hypothesize that lidocaine gel will decrease pain levels when compared to lubricant gel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

May 31, 2012

Results QC Date

January 7, 2015

Last Update Submit

January 16, 2015

Conditions

Pelvic Floor Disorders

Keywords

Urodynamic testingpelvic floor examinationLidocaine gelSurgical lubricantPainEmbarrassment

Outcome Measures

Primary Outcomes (1)

  • Pain During the Pelvic Floor Examination

    Subjects will be asked to report their pain level using the Wong Baker pain scale at the beginning of the exam, after a cotton tipped swab test, after the urodynamic catheters are placed in the urethra, and then 30 minutes after the completion of the exam. The Wong Baker pain scale ranges from 0 (no pain) to 10 (worst pain possible).

    30 minutes after completion of exam

Secondary Outcomes (1)

  • Embarrassment With Pelvic Floor Examination

    30 minutes

Study Arms (2)

2% lidocaine gel

ACTIVE COMPARATOR

Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.

Drug: 2% lidocaine gel

water based lubricant

ACTIVE COMPARATOR

Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.

Drug: Water based lubricant

Interventions

2% lidocaine gelDRUG

2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.

Also known as: Lidocaine Hydrochloride Jelly USP, 2%
2% lidocaine gel
Water based lubricantDRUG

Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.

Also known as: Surgilube (Savage Laboratories)
water based lubricant

Eligibility Criteria

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

You may qualify if:

  • Women 18 years of age or older
  • Scheduled to undergo multichannel urodynamic study
  • Able to give informed consent
  • Able to read and write in English or Spanish

You may not qualify if:

  • Any contraindication to multichannel urodynamic study
  • Allergy to water based lubricant or lidocaine
  • Any active pelvic or lower urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC USC Womens clinic

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Pelvic Floor DisordersPain

Interventions

phenylmercury borate

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPregnancy ComplicationsMale Urogenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Our patient population represented a predominantly Latina/Hispanic population, and our results might not be generalizable to other populations.

Results Point of Contact

Title
Begum Ozel, MD
Organization
University of Southern California
ozel@usc.edu
323-441-9589

Study Officials

  • Vanessa Sun, M.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 5, 2012

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

January 19, 2015

Results First Posted

January 19, 2015

Record last verified: 2015-01

Locations

US(1)