Gentamicin for Recurrent UTI

Overseen By Julia K Shinnick

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Women and Infants Hospital of Rhode Island

Must not be taking: Antibiotics, Aminoglycosides

Disqualifiers: Parkinsons, Myasthenia gravis, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)

Will I have to stop taking my current medications?

The trial requires that you have not taken any antibiotics within the last 4 weeks before starting. Other current medications are not specified, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug gentamicin for treating recurrent urinary tract infections?

Research shows that gentamicin can effectively eliminate bacteria in patients with recurrent urinary tract infections, especially in the lower urinary tract. In one study, 19 out of 23 patients had their infections cleared after treatment with gentamicin, and it was particularly effective for those without severe kidney issues. ^{1 2 3 4 5}

Is gentamicin safe for treating recurrent urinary tract infections?

Gentamicin has been used safely in treating recurrent urinary tract infections, with studies showing no significant side effects when used intravesically (directly into the bladder) in patients using clean intermittent catheterization. However, there is a case of kidney damage reported with a single dose, so monitoring kidney function is important. ^{4 6 7 8 9}

How does the drug gentamicin differ from other treatments for recurrent urinary tract infections?

Gentamicin is unique because it can be administered as a single daily dose, either intramuscularly or directly into the bladder, which is effective even against bacteria resistant to other antibiotics. This approach is particularly useful for patients with recurrent UTIs, especially those using clean intermittent catheterization, and it minimizes the risk of side effects by adjusting the dosage based on kidney function. ^{3 4 6 7 10}

Eligibility Criteria

This trial is for postmenopausal individuals who've had at least two urinary tract infections (UTIs) in the past six months and are interested in starting antibiotic treatment to prevent future UTIs.

Inclusion Criteria

I have gone through menopause.

I have had 2 urinary tract infections in the last 6 months.

I want to start taking antibiotics to prevent urinary tract infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravesical gentamicin instillation or oral nitrofurantoin prophylaxis to prevent recurrent UTIs

6 months

Weekly visits for intravesical group, self-reported doses for oral group

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Gentamicin

Trial Overview The study is testing if putting gentamicin directly into the bladder is as good or better than taking nitrofurantoin orally every day to stop recurrent UTIs. It's a feasibility assessment comparing these two approaches.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Gentamicin

Group II: Standard of Care Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

References

1. United States pubmed.ncbi.nlm.nih.gov

The use of intravesical gentamicin to treat recurrent urinary tract infections in lower urinary tract dysfunction. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Intravesical Gentamicin Treatment for Recurrent Urinary Tract Infections Caused by Multidrug Resistant Bacteria. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Treatment with a single daily dose of gentamicin in urinary tract infection in relation to the site of infection. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Treatment of chronic urinary tract infections with gentamicin. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Effects of gentamicin monotherapy for the initial treatment of community-onset complicated non-obstructive acute pyelonephritis due to Enterobacteriaceae in elderly and non-elderly women. [2014]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Intravesical gentamicin for recurrent urinary tract infection in patients with intermittent bladder catheterisation. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of gentamicin bladder irrigations in complex urological cases. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Adverse effects of a single dose of gentamicin in adults: a systematic review. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Aminoglycoside nephrotoxicity following single-dose cystoscopy prophylaxis. [2017]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of urinary tract infections in children with a single daily dose of gentamicin. [2004]