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Clinical trial

Intravesical Gentamicin to Prevent Recurrent UTI

ID
Name
2126175
Description
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)
Trial arms
Trial start
2024-08-01
Estimated PCD
2025-06-01
Trial end
2025-07-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Gentamicin
administered via bladder
Arms:
Experimental
Nitrofurantoin
administered PO
Arms:
Standard of Care
Size
30
Primary endpoint
UTIs
3 months, 6 months
Eligibility criteria
Inclusion criteria: * Postmenopausal * 2 UTIs in 6 months * desire to start antibiotic prophylaxis to prevent UTIs Exclusion criteria: * Parkinsons disease * myasthenia gravis * renal failure * liver failure * bladder pain syndrome * multiple negative urine cultures associated with UTI symptoms (\>/= 3) * bladder Botox treatments in the past * treatment planned for UI and prolapse * unevaluated microscopic hematuria * history of kidney stones * most recent weight \<40kg (88.18lbs) * surgically altered urinary tract (urinary diversion, phalloplasty, etc) * allergy or hypersensitivity to either of the study medications or medications in the same family including but not limited to: amikacin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

2 products

1 indication

Organization
Women and Infants Hospital of Rhode Island
Product
Gentamicin
Indication
Recurrent Urinary Tract Infection
Product
Nitrofurantoin