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Intraurethral Lidocaine After Endourology Procedures

NCT ID: NCT03537534

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2022-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Experiment

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

Group Type EXPERIMENTAL

Lidocaine Jet Injector

Intervention Type DRUG

Applying Lidocaine following endourologic procedure

Placebo

Surgilube 5mL x 1 dose only

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Applying surgilube following endourologic procedure

Interventions

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Lidocaine Jet Injector

Applying Lidocaine following endourologic procedure

Intervention Type DRUG

Placebos

Applying surgilube following endourologic procedure

Intervention Type DRUG

Other Intervention Names

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Urojet Surgilube

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Antonio Uniformed Services Health Education Consortium

FED

Sponsor Role lead

Responsible Party

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Christopher Allam

Director of Endourology and Laparoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Allam, DO

Role: PRINCIPAL_INVESTIGATOR

San Antonio Uniformed Services Health Education Consortium

Locations

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BAMC

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C.2018.055d

Identifier Type: -

Identifier Source: org_study_id

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