Intraurethral Lidocaine After Endourology Procedures

NCT03537534 | Terminated Phase 3 FDA Drug

• 1 other identifier: C.2018.055d
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysuria

Outcome Measures

Primary Outcomes (1)

• Subjective patient symptom score

  questionnaire scores

  1 day (immediately before and after procedure)

Secondary Outcomes (1)

• Patient complications

  within 30 days

Study Arms (2)

Experiment

EXPERIMENTAL

Lidocaine jelly (2%) 5mL x 1 dose only

Drug: Lidocaine Jet Injector

Placebo

PLACEBO COMPARATOR

Surgilube 5mL x 1 dose only

Drug: Placebos

Interventions

Lidocaine Jet Injector DRUG

Applying Lidocaine following endourologic procedure

Also known as: Urojet

Experiment

Placebos DRUG

Applying surgilube following endourologic procedure

Also known as: Surgilube

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• San Antonio Uniformed Services Health Education Consortium: lead

Study Sites (1)

BAMC

Fort Sam Houston, Texas, 78234, United States

Location

MeSH Terms

Conditions

Dysuria

Interventions

phenylmercury borate

Condition Hierarchy (Ancestors)

Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Allam, DO

  San Antonio Uniformed Services Health Education Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endourology and Laparoscopy

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: April 15, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)