Nephrolithiasis, Ureteral Calculi, Ureteral Stones
Conditions
Keywords
ureteral stones; ureteral calculi; shockwave lithotripsy
Brief summary
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.
Detailed description
This is a two arm, double blind randomized controlled trial (RCT) comparing the use of a single dose ciprofloxacin prior to shock wave lithotripsy (SWL) to placebo. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally. Eligibility criteria include patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria (outlined below). Eligible patients will provide written informed consent. Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete. Patients will undergo SWL using standard procedures at the participating center. Participants will asked to provide a pre-procedure study questionnaire, a modified International Prostate Symptom Score (IPSS) questionnaire and a urine sample for analysis prior to SWL and follow-up. Follow-up questionnaires and a requisition for urine culture will be provided in a pre-stamped, self-addressed envelope along with instructions to return both culture and questionnaires to their participating center at 7-14 days post-SWL. If the follow-up questionnaire has not been received by post-operative day 10 patients will receive a reminder phone call. A second envelope will be sent containing a requisition for urine culture and follow-up questionnaire when necessary. Alternatively, if a 2 week follow-up is conducted at the participating site then data-forms can be completed and collected at that time. In the event that a urine culture was not submitted 7 days post-operatively, one can be collected up to 14 days post-op. Additional clinical parameters such as presence of double J, stone characteristics and renal insufficiency will be recorded at the time of SWL by the dedicated research staff at the participating center. Data acquisition and occurrence of outcomes will be monitored continuously with scheduled audits. Primary and secondary outcomes are outlined below. The power calculation for this protocol was performed using Stata v.10.1 (StataCorp, College Station, TX). The investigators used the American Urological Association Best Practice Statement on antibiotic prophylaxis to estimate a 60% relative risk reduction with treatment arm. Therefore to achieve a power of 90% with a significance level of p\<0.05, 661 patients will need to be recruited in each arm for a total of 1,322 patients. Accounting for 10% loss to follow-up, the total required will be 1454, or approximately 1500 patients. Assuming that 25% of patients screened will either refuse to be randomized or will meet one of the pre-defined exclusion criteria, a minimum of 2000 patients will need to be screened in order to randomize 1500 patients.
Interventions
DRUGCiprofloxacin
Oral or intravenous ciprofloxacin prior to shockwave lithotripsy.
DRUGPlacebo
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.
Sponsors
University of Helsinki
Helsinki University Central Hospital
Western University, Canada
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
King Abdulaziz University
Hospital Sao Luiz
St. Petersburg State Pavlov Medical University
University Hospital, Basel, Switzerland
Tallaght University Hospital
Tabriz University of Medical Sciences
Dr Cipto Mangunkusumo General Hospital
Clinical Urology and Epidemiology Working Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients older than 18 years presenting for SWL who do not meet one of the pre-defined
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis | 7-14 days post-shockwave lithotripsy | The composite outcome with be assessed as a dichotomous variable. The presence of Positive post-SWL urine culture (≥ 10e5 Colony Forming Unit/ ml), with either one or more of 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) will be considered as an event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency | 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 | 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 |
| Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml | 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 |
| Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome) | 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 | 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 |
| Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome) | 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 |
Countries
Brazil, Canada, Finland, Indonesia, Iran, Ireland, Russia, Saudi Arabia, Switzerland
Outcome results
None listed