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Antibiotic Prophylaxis With Routine Ureteral Stent Removal (STENTABX)

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ClinicalTrials.gov Identifier: NCT02944825
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
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 2018
Estimated Study Completion Date : January 2018

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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02944825


Locations
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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    rlsur@ucsd.edu   
Contact: Seth K Bechis, MD    619-543-2628    sbechis@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Genesis HealthCare

Publications:
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Responsible Party: Roger L Sur, M.D., Director of Endourology, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02944825     History of Changes
Other Study ID Numbers: 160160
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
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:
Urolithiasis
UTI

Additional relevant MeSH terms:
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Urolithiasis
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Trimethoprim
Sulfamethoxazole
Anti-Infective Agents
Antitubercular 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
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Anti-Dyskinesia Agents
Cytochrome P-450 CYP2C8 Inhibitors