Intravesical Gentamicin to Prevent Recurrent UTI

NCT ID: NCT06332781

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2026-05-31

Brief Summary

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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)

Detailed Description

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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).

Conditions

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Recurrent Uti

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Standard of Care

Standard of care

Group Type ACTIVE_COMPARATOR

Nitrofurantoin

Intervention Type DRUG

administered PO

Experimental

Gentamicin

Group Type EXPERIMENTAL

Gentamicin

Intervention Type DRUG

administered via bladder

Interventions

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Nitrofurantoin

administered PO

Intervention Type DRUG

Gentamicin

administered via bladder

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Women & Infants Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julia K Shinnick

Role: CONTACT

401 274 1122

Facility Contacts

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Julia Shinnick

Role: primary

4012741122

Other Identifiers

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2126175 // CTR grant U54GM1156

Identifier Type: -

Identifier Source: org_study_id

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