Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)

Study Overview
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Brief Summary
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The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.

Official Title
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A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection

Conditions
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Urolithiasis

Intervention / Treatment
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* Drug: Ciprofloxacin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for SWL at St. Joseph's Hospital; 18 years of age or older; Willing and able to complete Questionnaires; Willing to submit urine sample for analysis at Day 7; Able to read and speak English. Exclusion Criteria: Pre-SWL urine analysis positive for nitrites or urine culture reveals >105 CFU/ml of bacteria (positive urine culture); Taking antibiotics for UTI or other cause; Requires an antibiotic post SWL; Suspected struvite stone (based on previous stone analysis, or partial staghorn); Presence of nephrostomy tube; Requiring cystoscopy on the day of SWL; Requiring ureteral stent on the day of SWL; Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC); Presence of urinary diversion (ie: ileal conduit); Any history of urosepsis; Known allergic reaction to ciprofloxacin/quinolones; Patient known to be pregnant; Previous randomization in this trial; In the opinion of the urologist, it is not in the patient's best interest to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* 5% Dextrose in water<br>|
| Active Comparator: Ciprofloxacin<br>Ciprofloxacin | Drug: Ciprofloxacin<br>* Once, 400 mg IV<br>* Other names: Ciprofloxacin Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of antibiotic prophylaxis on the rate of urinary tract infection | Our primary outcome will be a composite endpoint comprised of: Positive post-SWL urine culture (≥ 105 colony forming units / millilitre (CFU/ml), symptoms of cystitis (defined as new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever ≥38.5 C). | Post SWL Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria post-SWL (≥105 cfu/ml) |  | 7-14 days | 
| Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency) |  | 7-14 days | 
| Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C) |  | 7-14 days | 
| Change in Urinary Symptom Score(reported as positive or negative integer) |  | 7 - 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotics, Shock Wave Lithotripsy, Urinary Tract Infection