Double Blinded Randomized Trial Between Lidocaine And Plain Gel For Urethral Straight Catheterization And The Q-Tip Test

This study has been completed.
Sponsor:
Information provided by:
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT00883103
First received: April 15, 2009
Last updated: August 10, 2011
Last verified: August 2011
  Purpose

The purpose of this study is to compare the pain perception between lidocaine and plain aqueous gel during assessment of postvoid residual volume and the Q-tip test.


Condition Intervention Phase
Pain
Drug: 2% Lidocaine jelly
Drug: Plain aqueous gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blinded Randomized Trial Between Lidocaine Jelly And Plain Aqueous Gel For Urethral Straight Catheterization And The Q-Tip Test

Resource links provided by NLM:


Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • Patient's Perception of Pain Using the Wong-Baker FACES Visual Scale: 0 - no Pain; 5 - Worst Imaginable Pain [ Time Frame: Immediately after the examination ] [ Designated as safety issue: No ]
    A sterile catheter lubricated with the allocated gel was placed transurethrally into the bladder to measure the postvoid residual volume. After removal of the catheter, a cotton swab, coated with the same allocated gel, was advanced to the urethrovesical junction until resistance was felt. The angle of the swab with the horizontal plane was measured at rest and with a Valsalva maneuver. Immediately following the Q-tip test, the patient's perception of pain level was measured by Wong-Baker FACES Pain Scale, a visual scale where 0 represents no pain and 5 represents worst imaginable pain.


Enrollment: 137
Study Start Date: November 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine
2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Drug: 2% Lidocaine jelly
2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Placebo Comparator: Aqueous gel
Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Drug: Plain aqueous gel
Plain aqueous gel will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
Other Name: Surgilube

Detailed Description:

This study was approved by the institutional review board at Baystate Medical Center. The study pool consists of all women who present to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse. Those patients who consent for the research will be then randomized either to 2% Lidocaine Hydrochloride jelly (Akorn, Buffalo Grove, IL) or Surgilube (Fougera, Melville, NY) using computer generated blocks of 10. The latter is a commonly used, commercially available aqueous lubricant gel. Both the urogynecologist who perform the examinations and the patient will be blinded to the randomization. The appearances of the study gels are indistinguishable. Based on our power analysis targeting a power of 0.80, an α value of 0.05, and 20% difference in pain perception between the groups, we are aiming to recruit a sample of minimum132 subjects.

First, demographic information including the age, parity, previous vaginal births, body mass index (BMI), race, diabetes, vaginal atrophy, neurological impairment, current estrogen use, indication for visit and exam anxiety will be collected as a part of patient history. Immediately after voiding, each patient will be placed in a lithotomy position. An independent nurse who is not involved in patient's care will prepare the study gels according to the randomization. After cleansing external urethral meatus with povidone iodine solution, a lubricated a sterile 14-French polyvinyl chloride Mentor Self-Cath catheter (Coloplast, Minneapolis, MN) will be placed transurethrally into the bladder to measure the postvoid residual volume. Following removal of the catheter, a cotton swab, lubricated with the same allocated gel, will be advanced to the urethrovesical junction until resistance was felt. The angle of the Q-tip with the horizontal plane will be measured at rest and with Valsalva maneuver. All the examinations will be performed by the same urogynecologist in the same order. Immediately following the Q-tip test, patient's perception of pain level will be measured using a validated pain scoring system, the Wong-Baker FACES visual scale where 0 represented no pain and 5 represented worst imaginable pain. The rest of the physical examination will be completed after this pain assessment.

We will evaluate patient characteristics and pain score variables by exposure to either Lidocaine or Surgilube using SPSS Version 11.01 software (Chicago, Illinois). For continuous variables, we will calculate the mean and standard deviation and then evaluate significant differences using the Mann Whitney U test. For categorical variables, we will calculate the number and percent and then evaluate significant differences using Pearson's chi-square test. Significance for all results was set at an alpha of <0.05.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All women who presented to a single urogynecologist's office for an initial consultation with a complaint of urinary incontinence and/or pelvic organ prolapse

Exclusion Criteria:

  • Being a minor
  • Pregnancy
  • Allergy to Lidocaine or aqueous lubricant gel
  • Any current use of analgesia
  • Structural abnormalities of the urethra
  • Active genital Herpes or other vulvovaginal infections or inability to cooperate with pain assessment due to mental disorders.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883103

Locations
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Investigators
Principal Investigator: Oz Harmanli, MD Baystate Medical Center
  More Information

Publications:
Responsible Party: Oz Harmanli, MD, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT00883103     History of Changes
Other Study ID Numbers: 07-091
Study First Received: April 15, 2009
Results First Received: July 18, 2011
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Baystate Medical Center:
female urethral catheterization
Lidocaine
lubricant
Q-tip test
Q tip test
K-Y jelly
pain perception
straight catheterization

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014