Urolithiasis Clinical Trial
— STENTABXOfficial title:
A Randomized, Prospective, Single-Blinded Control Trial to Assess the Need for Antibiotic Prophylaxis With Routine Ureteral Stent Removal After Kidney Stone Procedure
NCT number | NCT02944825 |
Other study ID # | 160160 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | January 2025 |
Verified date | March 2020 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | January 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Age: >=18 years of age Gender: both men and women included. We anticipated enrolling a study population of approximately 60% men and 40% women based on a higher incidence of kidney stones among men in NHANES data. Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions. Health Status: see below for specific inclusion/exclusion criteria. Inclusion criteria: - Patients with indwelling ureteral stents placed within the 2 weeks prior to the procedure visit for removal - Patients having underwent kidney stone treatment surgery (shockwave lithotripsy [SWL], ureteroscopy [URS], retrograde intrarenal surgery [RIRS], percutaneous nephrolithotomy [PNL]) Exclusion criteria - Patients with indwelling urethral catheter - Patients with indwelling suprapubic catheter - Patients with indwelling nephrostomy tube - Patients who perform clean intermittent catheterization - Pregnancy |
Country | Name | City | State |
---|---|---|---|
United States | University of California, San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | Genesis HealthCare |
United States,
National Nosocomial Infections Surveillance (NNIS) report, data summary from October 1986-April 1996, issued May 1996. A report from the National Nosocomial Infections Surveillance (NNIS) System. Am J Infect Control. 1996 Oct;24(5):380-8. — View Citation
Ramaswamy K, Shah O. Antibiotic prophylaxis after uncomplicated ureteroscopic stone treatment: is there a difference? J Endourol. 2012 Feb;26(2):122-5. doi: 10.1089/end.2011.0360. Epub 2011 Oct 17. — View Citation
Urban JA. Cost analysis of surgical site infections. Surg Infect (Larchmt). 2006;7 Suppl 1:S19-22. Review. — View Citation
Wolf JS Jr, Bennett CJ, Dmochowski RR, Hollenbeck BK, Pearle MS, Schaeffer AJ; Urologic Surgery Antimicrobial Prophylaxis Best Practice Policy Panel. Best practice policy statement on urologic surgery antimicrobial prophylaxis. J Urol. 2008 Apr;179(4):1379-90. doi: 10.1016/j.juro.2008.01.068. Epub 2008 Feb 20. Erratum in: J Urol. 2008 Nov;180(5):2262-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-procedure Infectious Complication | Urinary Tract Infection (UTI) | 30 days | |
Secondary | Patient Risk Factors Predisposing to Post-procedure Infectious Complications | Urinary Tract Infection (UTI) Risk Factors | 30 days |
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