Intraurethral Lidocaine After Endourology Procedures

Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients

Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.

Study Overview

• Status: Terminated
• Conditions: Dysuria
• Intervention / Treatment: Drug: Lidocaine Jet Injector; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • BAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.

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Exclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experiment; Lidocaine jelly (2%) 5mL x 1 dose only	Drug: Lidocaine Jet Injector; Applying Lidocaine following endourologic procedure; Other Names: Urojet
Placebo Comparator: Placebo; Surgilube 5mL x 1 dose only	Drug: Placebos; Applying surgilube following endourologic procedure; Other Names: Surgilube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective patient symptom score	questionnaire scores	1 day (immediately before and after procedure)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient complications	Unplanned patient returns to clinic or ED, UTIs, admissions	within 30 days

Collaborators and Investigators

• Sponsor: San Antonio Uniformed Services Health Education Consortium
• Investigators: Principal Investigator: Christopher Allam, DO, San Antonio Uniformed Services Health Education Consortium

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Dysuria; 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: C.2018.055d

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: Yes