Intraurethral Lidocaine After Endourology Procedures

Dysuria Clinical Trial

Official title:

Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03537534
• Other study ID #: C.2018.055d
• Status: Terminated
• Phase: Phase 3
• Start date: April 15, 2018
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2024
• Source: San Antonio Uniformed Services Health Education Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Dysuria

Intervention

Drug:
• Lidocaine Jet Injector
Applying Lidocaine following endourologic procedure
• Placebos
Applying surgilube following endourologic procedure

Locations

Country	Name	City	State
United States	BAMC	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
San Antonio Uniformed Services Health Education Consortium

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective patient symptom score	questionnaire scores	1 day (immediately before and after procedure)
Secondary	Patient complications	Unplanned patient returns to clinic or ED, UTIs, admissions	within 30 days