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Antibiotic Prophylaxis With Routine Ureteral Stent Removal (STENTABX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02944825
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : March 24, 2020
Genesis HealthCare
Information provided by (Responsible Party):
Roger L Sur, M.D., University of California, San Diego

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Urolithiasis UTI Drug: Ciprofloxacin Drug: trimethoprim/sulfamethoxazole Drug: No Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Prospective, Single-Blinded Control Trial to Assess the Need for Antibiotic Prophylaxis With Routine Ureteral Stent Removal After Kidney Stone Procedure
Study Start Date : January 2016
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Antibiotic
Patients randomized to the intervention arm will be provided a single oral dose of prophylactic oral antibiotic at the time of cystoscopic stent removal
Drug: Ciprofloxacin
first line prophylactic oral antibiotic

Drug: trimethoprim/sulfamethoxazole
second line prophylactic oral antibiotic
Other Names:
  • Bactrim
  • Septra

Active Comparator: No Antibiotic
Patients randomized to the non-intervention arm will not undergo prophylaxis at the time of cystoscopic stent removal
Drug: No Intervention
No intervention

Primary Outcome Measures :
  1. Post-procedure Infectious Complication [ Time Frame: 30 days ]
    Urinary Tract Infection (UTI)

Secondary Outcome Measures :
  1. Patient Risk Factors Predisposing to Post-procedure Infectious Complications [ Time Frame: 30 days ]
    Urinary Tract Infection (UTI) Risk Factors

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02944825

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United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92101
Contact: Roger L Sur, MD    619-543-2628   
Contact: Seth K Bechis, MD    619-543-2628   
Sponsors and Collaborators
University of California, San Diego
Genesis HealthCare
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Responsible Party: Roger L Sur, M.D., Director of Endourology, University of California, San Diego Identifier: NCT02944825    
Other Study ID Numbers: 160160
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Secure Server Data Sharing System
Keywords provided by Roger L Sur, M.D., University of California, San Diego:
Additional relevant MeSH terms:
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Urinary Calculi
Urologic Diseases
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors