Intravesical Gentamicin to Prevent Recurrent UTI

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Uti
• Intervention / Treatment: Drug: Nitrofurantoin; Drug: Gentamicin

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care; Standard of care	Drug: Nitrofurantoin; administered PO
Experimental: Experimental; Gentamicin	Drug: Gentamicin; administered via bladder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UTIs	culture-proven UTIs	3 months, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome measures	UTI Symptom Assessment	3 months, 6 months
Patient reported outcome measures	recurrent UTI symptom scale	3 months, 6 months
Patient reported outcome measures	recurrent UTI impact questionaire	3 months, 6 months
Patient reported outcome measures	short-form-36	3 months, 6 months
Patient reported outcome measures	general anxiety disorder-7	3 months, 6 months
Patient reported outcome measures	patient health questionnaire	3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
urobiome analysis	bacterial presence	3 months, 6 months
urobiome analysis	antimicrobial resistance gene presence	3 months, 6 months

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Urologic Diseases; Disease Attributes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Recurrence; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Anti-Infective Agents, Urinary; Gentamicins; Nitrofurantoin
• Other Study ID Numbers: 2126175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No