Use of Antibiotic Based Irrigation for Ureteroscopic Treatment of Urolithiasis
Urinary Tract Infections, Sepsis
About this trial
This is an interventional prevention trial for Urinary Tract Infections focused on measuring UTI, Gentamicin, Ureteroscopy
Eligibility 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
Sites / Locations
- Yale New Haven Health
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Gentamicin-Based Irrigation
3 L NaCl Irrigation
This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
This group will receive the typical NaCl irrigation used during ureteroscopy