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Intraurethral Lidocaine After Endourology Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537534
Recruitment Status : Unknown
Verified May 2018 by Christopher Allam, San Antonio Uniformed Services Health Education Consortium.
Recruitment status was:  Recruiting
First Posted : May 25, 2018
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Allam, San Antonio Uniformed Services Health Education Consortium

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.

Condition or disease Intervention/treatment Phase
Dysuria Drug: Lidocaine Jet Injector Drug: Placebos Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experiment
Lidocaine jelly (2%) 5mL x 1 dose only
Drug: Lidocaine Jet Injector
Applying Lidocaine following endourologic procedure
Other Name: Urojet

Placebo Comparator: Placebo
Surgilube 5mL x 1 dose only
Drug: Placebos
Applying surgilube following endourologic procedure
Other Name: Surgilube




Primary Outcome Measures :
  1. Subjective patient symptom score [ Time Frame: 1 day (immediately before and after procedure) ]
    questionnaire scores


Secondary Outcome Measures :
  1. Patient complications [ Time Frame: within 30 days ]
    Unplanned patient returns to clinic or ED, UTIs, admissions



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537534


Contacts
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Contact: Christopher L Allam, DO 210-916-6604 christopher.l.allam.mil@mail.mil
Contact: Felicia Balzano, MD 210-916-0716 felicia.l.balzano.mil@mail.mil

Locations
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United States, Texas
BAMC Recruiting
Fort Sam Houston, Texas, United States, 78234
Contact: Christopher Allam, DO         
Sponsors and Collaborators
San Antonio Uniformed Services Health Education Consortium
Investigators
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Principal Investigator: Christopher Allam, DO San Antonio Uniformed Services Health Education Consortium
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Responsible Party: Christopher Allam, Director of Endourology and Laparoscopy, San Antonio Uniformed Services Health Education Consortium
ClinicalTrials.gov Identifier: NCT03537534    
Other Study ID Numbers: C.2018.055d
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Dysuria
Lower Urinary Tract Symptoms
Urological Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action