Intravesical Gentamicin to Prevent Recurrent UTI

Women and Infants Hospital of Rhode Island20 enrolled

Overview

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)

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Recurrent Uti

Interventions

GentamicinDRUG

administered via bladder

NitrofurantoinDRUG

administered PO

Eligibility

Sex: FEMALEMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Women & Infants Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Assess feasibility of trial recruitment

measure screening ratio (number of people screened versus number enrolled)

Time frame: 3 months

Examine treatment compliance

compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group

Time frame: 3 months

Examine trial retention

compare the proportion of participants retained in each group

Time frame: 3 months