Intravesical Gentamicin to Prevent Recurrent UTI

Women and Infants Hospital of Rhode Island

Status and phase: Enrolling; Phase 4

Conditions: Recurrent Uti

Treatments: Drug: Gentamicin; Drug: Nitrofurantoin

Study type: Interventional

Funder types: Other

Identifiers

NCT06332781

2126175 // CTR grant U54GM1156

Details and patient eligibility

About

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)

Full description

The overall goal of this project is to assess the feasibility of a larger trial investigating the use 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). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).

Enrollment: 30 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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
• no antibiotics within 4 weeks
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard of Care

Active Comparator group

Description:

Standard of care

Treatment:

Drug: Nitrofurantoin

Experimental

Experimental group

Description:

Gentamicin

Treatment:

Drug: Gentamicin