Lidocaine for Pain After Urodynamic Testing

The Impact of Pre-procedure Periurethral Topical Lidocaine Application on Pain Scores After Complex Urodynamic Testing in Women

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying external lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder; Urinary Incontinence; Voiding Disorders
• Intervention / Treatment: Drug: Lidocaine gel 2%; Other: Standard lubricant gel

Detailed Description

Urodynamic testing can be associated with mild discomfort, particularly at the time of insertion, repositioning, and removal of the bladder catheter (a tube inserted into the bladder via the urethra). Few studies have investigated ways to improve patient comfort during this procedure. In this study, the investigators want to see if applying lidocaine (a numbing gel) prior to the procedure can help to minimize patient discomfort.

Participation in this study will involve only 1 clinic visit (for urodynamic testing), plus 2 phone calls to ask participants about pain (1 at 4-6 hours after testing; and 1 at 24 hours after testing). Additionally, the investigators will record any adverse effects (such as an allergic reaction to the gel or new irritation/pain) that happen within 2 weeks after testing.

Participants will be randomly assigned to receive either lidocaine gel or placebo gel for their urodynamic testing. The placebo gel will be a standard lubricant gel, meaning that it contains no active drug. The assigned study regimen will be chosen by chance, like flipping a coin. Participants will have an equal (50/50) chance of being given either study regimen. Neither the participant nor the study doctor or nurse practitioner will know which study regimen the participant is getting. Additionally, a member of the study team will ask participants about their pain level before and after the testing. The rest of the urodynamic testing procedure will take place exactly as it would if the participant was not in this research study.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All female patients between the ages of 40-80 undergoing urodynamic testing.

Exclusion Criteria:

• Urinary tract infection or symptoms of infection at time of procedure or within past 2 weeks
• History of urinary retention
• Known or suggested history of urethral syndrome or painful bladder syndrome
• Prior anti-incontinence surgery
• Prior pelvic surgery with placement of transvaginal mesh
• Known urethral or bladder anomaly including urethral diverticulum or congenital anomalies of the bladder or urethra
• History of genital herpes outbreak within the past 3 months
• Defects in mucosal surfaces including periurethral or vaginal abrasions, ulcerations, or lacerations
• Neurologic disease affecting urethral sensation
• Chronic pelvic pain
• Contraindication or allergy to topical anesthetic
• Pregnancy
• Syncopal episode during preparation for or execution of uroflowometry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lidocaine gel; If assigned to this arm, participants have lidocaine gel 2% applied to their external urethra and vagina one time prior to the urodynamics procedure.	Drug: Lidocaine gel 2%; If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.
PLACEBO_COMPARATOR: Lubricant gel; If assigned to this arm, participants will have a standard lubricant gel applied to their external urethra and vagina prior to the urodynamics procedure.	Other: Standard lubricant gel; If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in patient visual analog pain score (vaginal area only) from before procedure to 4-6 hours after urodynamic testing	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 4-6 hours post procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient visual analog pain score (vaginal area only) from before procedure to 24 hours after urodynamic testing.	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 24 hours post procedure.
Patient visual analog pain score (vaginal area only) before procedure, at conclusion of all procedure-related activities, 4-6 hours after procedure, and 24 hours after procedure.	Participants will rate their pain according to a visual analog pain scale from 0 (no pain) to 100 (worst pain imaginable).	Baseline and 24 hours post procedure.
To assess voiding difficulties and other adverse events immediately after urodynamic testing, at 4-6 hours, 24 hours, and two weeks after urodynamic testing.	Participants will receive a phone call at 4-6 hours and 24 hours after urodynamic testing. Any study participant-initiated complaints of voiding difficulties within two weeks of the procedure will be documented and addressed.	Baseline and 2 weeks post-procedure.
Urodynamic findings	Standard urodynamics findings will be analyzed.	At time of procedure.
Procedure time	Procedure time will be recorded for all subjects.	At time of procedure.

Collaborators and Investigators

• Sponsor: Atlantic Health System

Publications and helpful links

General Publications

• Avondstondt AM, Chiu S, Salamon C. Periurethral Lidocaine Does Not Decrease Pain After Urodynamic Testing in Women: A Double-Blinded Randomized Control Trial. Female Pelvic Med Reconstr Surg. 2021 May 1;27(5):e528-e532. doi: 10.1097/SPV.0000000000000983.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2018
• Primary Completion (ACTUAL): March 29, 2019
• Study Completion (ACTUAL): March 29, 2019

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: January 3, 2018
• First Posted (ACTUAL): January 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Bladder, Overactive; Urinary Incontinence; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1112951-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No