Antibiotic Prophylaxis With Routine Ureteral Stent Removal

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.

Investigational portion of treatment:

Patients randomized to the intervention arm will be provided a single oral dose of
Ciprofloxacin 500mg at the time of stent removal. Ciprofloxacin is currently indicated for
the treatment of acute uncomplicated urinary tract infections. Patients with fluoroquinalone
allergy will receive Bactrim (trimethoprim/sulfamethoxazole 160/800mg) single dose instead of
Ciprofloxacin. Those patients that do develop infectious complications after stent removal
will be treated empirically based on the preference of the treating physician followed by
culture specific antibiotics. Centeral prophylaxis randomization will take place at UCSD, as
the lead site, using staff members not involved in patient management. Randomization will
occur in block randomization in block sizes of 10.

Standard of care procedures Patients will have cystoscopy and stent removal performed in
standard fashion, without deviation from standard of care. The time frame of stent removal
after initial stone procedure is consistent with current standard of care. If the treating
physician's preference is to maintain the patient's indwelling stent for longer than two
weeks, then the patient would not be considered for this study. No patient's management
course will be altered for inclusion into this study.

All female patients are screened with a urinary pregnancy test during the preoperative
screening visit, which occurs before the kidney stone surgery. Any pregnant female patients
will be excluded from participation in this study. Post-operative instructions include
refraining from sexual activity. Cystoscopic stent removal is performed within 14 days of
surgery.

Demographic fields that will be obtained preoperatively include age, race, gender, body mass
index (BMI), and comorbidities including history of diabetes mellitus, immunosuppression,
prior urinary tract infection(s), neurogenic bladder, incomplete bladder emptying.
Pre-operative clinical data points will include kidney stone size (largest diameter as
measured on coronal imaging for either kidney-ureter-bladder plain x-ray or computerized
tomography) and pre-operative urine culture results.

Post-procedure fields will include post-void residual urine volume per bladder scan (to
assess emptying capability), culture of urine collected during stent removal (only to be
treated with antibiotics if patient becomes symptomatic - per standard of care), stone
culture results, stone analysis, and stone-free status. Phone call interview will occur
between 7-14 days post-operatively to determine if any post-operative infectious events have
occurred. Any infectious symptoms (see below) will prompt mid-stream clean catch specimen for
urinalysis and urine culture. During this period, patients will be closely observed for
infectious complication--ie. symptomatic urinary tract infection, defined as presence of
bacteruria (>5k colony forming units) with any of the following: fever >38 C, malodorous
urine, dysuria, urinary frequency, urinary urgency, lower abdominal discomfort, back pain,
gross hematuria. . Patients will be evaluated at 8 weeks for re-assessment in the clinic with
a renal bladder ultrasound performed at 6 weeks, which is the routine post-operative care.

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