Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to investigate whether the use of gentamicin-based irrigation fluid during ureteroscopy decreases the risk of UTIs and other post-operative infections after surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yale University
• Treatments: Gentamicins

Criteria

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Diagnosed with urolithiasis (obstructing ureteral stone, large non-obstructing renal stones) warranting surgical intervention in line with American Urological Association guidelines for urolithiasis

• At a higher risk for infectious complications following ureteroscopy based on a history of atleast one of the below:

• 3 more urinary tract infections over 12 month period not on suppressive antibiotic therapy

• Prior infectious complication following ureteroscopy

• Placement of ureteral stent in the setting of obstructing ureteral stone with concern for superimposed urinary tract infection

• Positive pre-operative urine culture treated with culture-appropriate antimicrobial therapy

• Planned for cystoscopy, ureteroscopy with possible laser lithotripsy, and ureteral stent placement

• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of gentamicin administration. Female patients of reproductive potential will have pregnancy screen prior to surgery per standard operating room protocol.

• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

• Estimated Glomerular Filtration Rate less than 60 mL/min

• History of sensorineural hearing loss, vertigo, idiopathic dizziness

• Active pregnancy or currently lactating

• Known allergic reactions to components of gentamicin

• Administration of intravenous gentamicin as part of surgical antibiotic prophylaxis