Antibiotic Prophylaxis Before Shock Wave Lithotripsy

• Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml[ Time Frame: 7-14 days post-shockwave lithotripsy ]
  Bacteriuria will be assessed as a dichotomous variable with presence of is ≥100000 Colony Forming Unit/ml will be considered as an event
• Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency[ Time Frame: 7-14 days post-shockwave lithotripsy ]
  Symptoms of cystitis will be considered as a dichotomous variable with new onset burning sensation or pain with voiding, frequency, urgency will be considered an event
• Pyelonephritis or urosepsis defined as Hospital admission with fever ≥38.5 Celsius[ Time Frame: 7-14 days post-shockwave lithotripsy ]
  Pyelonephritis or urosepsis will be assessed as a dichotomous variable with Hospital admission with fever ≥38.5 Celsius will be considered as an event
• Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome)[ Time Frame: 14 days post-shockwave lithotripsy ]
  Change in total value of IPSS score will be assessed as a continuous variable with a range from 0-35 with higher scores indicating more severe symptoms. This score is calculated by summation of individual component scores (0-5) across 7 domains
• Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome)[ Time Frame: 14 days post-shockwave lithotripsy ]
  Individual IPSS domains will be assessed as continuous variables and include incomplete emptying, frequency, intermittency, urgency, weak stream, straining and nocturia. Higher scores as considered as more severe symptoms
• Pain scale determined on a range of 0-5 with higher score indicating worse outcome[ Time Frame: 14 days post-shockwave lithotripsy ]
  Pain scale will be assessed as a continuous variable. The scale will be elicited by asking In the past week, how often have you had burning or discomfort with urination? Higher score is considered as more severe symptoms

This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.

• Drug: Ciprofloxacin
  Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.
• Drug: Placebo
  identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.

• Experimental: ciprofloxacin
  Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy
• Placebo Comparator: Placebo
  identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.