Antibiotic Irrigation for Kidney Stones
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether using gentamicin (an antibiotic) irrigation fluid during ureteroscopy can reduce the risk of urinary tract infections (UTIs) and other infections after kidney stone surgery. Participants will be divided into two groups: one will receive the standard saline solution, while the other will receive the gentamicin solution. Ideal candidates are those with kidney stones requiring surgery who have frequently experienced UTIs or infections after similar procedures. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that gentamicin can be safe in medical treatments, though it carries some risks. For instance, gentamicin may accumulate in the kidneys, potentially causing mild issues like protein in the urine or a slight decrease in kidney function. However, it is less harmful to the kidneys compared to other antibiotics in its group. Previous studies successfully used gentamicin for bladder treatments, with patients finding it effective and manageable. Overall, despite some risks, gentamicin has been used safely in similar situations before.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about Gentamicin-based irrigation for kidney stones because it introduces an antibiotic component directly into the irrigation fluid used during ureteroscopy. Unlike the standard saline irrigation, which simply flushes the area, Gentamicin-based irrigation could actively reduce bacterial load and potentially lower infection rates during the procedure. This direct application of an antibiotic during surgery is innovative and could enhance patient outcomes by preventing post-operative infections, a common complication with kidney stone procedures.
What evidence suggests that gentamicin-based irrigation is effective for reducing post-operative infections after ureteroscopy?
This trial will compare a gentamicin-based irrigation solution with standard NaCl irrigation during ureteroscopy. Research has shown that using a gentamicin solution during ureteroscopy can help reduce infections. One study found that this antibiotic solution effectively cleaned the kidney area during stone treatment. Gentamicin, an antibiotic, kills bacteria and prevents infections after surgery. Another study found that patients who used gentamicin solution had fewer urinary tract infections (UTIs) after their procedures. Overall, these findings suggest that gentamicin solution could be a promising way to lower the risk of infections after surgery.678910
Who Is on the Research Team?
Piruz Motamedinia, M.D.
Principal Investigator
Yale School of Medicine, Department of Urology
Are You a Good Fit for This Trial?
This trial is for adults needing surgery for kidney stones who can consent and follow the study plan. They must have had a positive urine culture treated with antibiotics, use effective contraception, and be at higher risk of post-surgery infection due to past UTIs or complications. Excluded are those with poor kidney function, pregnant or breastfeeding women, allergies to gentamicin, recent IV gentamicin use, or certain ear-related health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ureteroscopic surgery with either gentamicin-based or NaCl irrigation fluid
Follow-up
Participants are monitored for post-operative infections and other complications
What Are the Treatments Tested in This Trial?
Interventions
- Gentamicin
Trial Overview
The study tests if using gentamicin in the irrigation fluid during ureteroscopy can lower post-operative infections compared to a placebo. Participants will undergo standard procedures like cystoscopy and possible laser lithotripsy while being monitored for urinary tract infections (UTIs).
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
This group will receive 120 mg of Gentamicin in 3 L NaCl as irrigation fluid during ureteroscopy
This group will receive the typical NaCl irrigation used during ureteroscopy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
Citations
A new protocol for renal collecting system sterilization with ...
The reliability, efficacy, and utility of antibiotic irrigation during lithotripsy in RIRS were presented in this study as a new protocol for ...
Novel Irrigation Protocol for Renal Pelvis Sterilization ...
Gentamicin in normal saline (80 mg/3 L) was utilized as the irrigant fluid for the first 6 L of irrigation. From this cohort, 57% patients were women and mean ...
3.
urology.wisc.edu
urology.wisc.edu/wp-content/uploads/2024/10/Intravesical-Gent-Neurourology-and-Urodynamics-Articles-In-Press.pdfEffectiveness and patient perspective on the use of ...
Conclusion: Gentamicin bladder instillations with 15 mg nightly in patients with indwelling catheters or CIC with NGLUTD are very effective and ...
Use and Effectiveness of Antimicrobial Intravesical Treatment ...
Overall, a good reduction in symptomatic UTI was seen in 78%, with a short-term success rate and discontinuation rates of 71% (120/168) and 8% (14/168) in the ...
5.
springermedizin.de
springermedizin.de/a-new-protocol-for-renal-collecting-system-sterilization-with-an/26963056A new protocol for renal collecting system sterilization with ...
In the antibiotic irrigation group, by dissolving 80 mg gentamicin in a 3 L irrigation pouch of normal saline, a 26.7 mg/L concentration was obtained.
Gentamicin - StatPearls - NCBI Bookshelf - NIH
The gentamicin is prone to accumulate in the renal proximal tubular cells and can cause damage. Hence, mild proteinuria and reduction of the glomerular ...
Overview of Antibiotic-Induced Nephrotoxicity
Drug-induced nephrotoxicity accounts for up to 60% of cases of acute kidney injury (AKI) in hospitalized patients and is associated with ...
Overview of Antibiotic-Induced Nephrotoxicity - PMC
Of the aminoglycosides, the most nephrotoxic is neomycin, followed by gentamicin, tobramycin, and amikacin. Streptomycin appears to be the least nephrotoxic.
A new protocol for renal collecting system sterilization with ...
The aim of this study was to provide collecting system sterilization during lithotripsy with the use of antibiotic irrigation solution in RIRS.
Effectiveness and patient perspective on the use of ...
Gentamicin bladder instillations with 15 mg nightly in patients with indwelling catheters or CIC with NGLUTD are very effective and safe with high patient ...
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