A Randomized, Prospective, Single-Blinded Control Trial to Assess the Need for Antibiotic Prophylaxis With Routine Ureteral Stent Removal After Kidney Stone Procedure

This study will be a single-institutional randomized, single-blinded prospectively controlled clinical trial of a single dose of Ciprofloxicin 500mg antibiotic tablet as prophylaxis at the time of office flexible cystoscopy with ureteral stent removal. The control group will be no prophylaxis oral antibiotics. The study will be conducted at UCSD Urology outpatient clinic and Genesis Healthcare Partners Urology outpatient clinic. UCSD will be the coordinating institution.

Treatment Assignment:

Patients will be assigned to control or intervention arm based on a predetermined allocation sequence that will be generated by a computerized random number generator. Study staff not participating in patient recruitment or procedure will manage the allocation sequence. Physicians involved in urologic patient care will be blinded from the participants' allocation. Only study staff at the coordinating institution (UCSD) will have access to the full allocation sequence. i.e. no clinical staff involved in recruiting and consenting patients for the study at UCSD or other participating institutions will have knowledge of the allocation sequence at their institution prior to enrollment of each patient. To further aid allocation concealment, the block size will be varied.

Standard of care procedures:

Patients will be identified at the time of clinic visit for cystoscopic stent removal. All patients will be counseled on the American Urological Association's clinical guidelines for prophylactic antibiotic use, and the varied standardization of practice patterns. We will not deviate from routine care standards. Patients undergoing routine ureteral stent removal within two weeks following stone treatment procedure (ie. Percutaneous Nephrolithotomy, Ureteroscopy, Retrograde Intrarenal Surgery, or Extracorporal Shockwave Lithotripsy). Patients that agree to participate and provide consent will be enrolled into the study, receiving a randomized allocation, and specific data points will be collected prospectively. Patients will be consented prior to determination of prophylaxis for collection of demographic, disease, perioperative, and postoperative data. If the patient does not consent to the study the use of antibiotics will be based on the routine clinical practice of the treating urologist.