Intraurethral Lidocaine After Endourology Procedures

Study Overview
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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.

Official Title
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Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients

Conditions
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Dysuria

Intervention / Treatment
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* Drug: Lidocaine Jet Injector
* Drug: Placebos


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |