Intraurethral Lidocaine After Endourology Procedures

Phase 3

Terminated

• Conditions: Dysuria
• Interventions: Drug: Lidocaine Jet Injector; Drug: Placebos

• Registration Number: NCT03537534
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-15
• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-25
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experiment	Lidocaine Jet Injector	Lidocaine jelly (2%) 5mL x 1 dose only
Placebo	Placebos	Surgilube 5mL x 1 dose only

Primary Outcome Measures

Name	Time	Method
Subjective patient symptom score	1 day (immediately before and after procedure)	questionnaire scores

Secondary Outcome Measures

Name	Time	Method
Patient complications	within 30 days	Unplanned patient returns to clinic or ED, UTIs, admissions

Trial Locations

Locations (1)

BAMC; 🇺🇸 Fort Sam Houston, Texas, United States