Intravesical Gentamicin to Prevent Recurrent UTI

Phase 4

Recruiting

• Conditions: Recurrent Uti
• Interventions: Drug: Nitrofurantoin; Drug: Gentamicin

• Registration Number: NCT06332781
• Lead Sponsor: Women and Infants Hospital of Rhode Island

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-27
• Study Start: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Nitrofurantoin	Standard of care
Experimental	Gentamicin	Gentamicin

Primary Outcome Measures

Name	Time	Method
Assess feasibility of trial recruitment	6 months	measure screening ratio (number of people screened versus number enrolled)
Examine treatment compliance	6 months	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
Examine trial retention	6 months	compare the proportion of participants retained in each group

Secondary Outcome Measures

Name	Time	Method
culture-proven UTIs	3 and 6 months
Patient reported outcome measures	3 months, 6 months	patient health questionnaire

Trial Locations

Locations (1)

Women & Infants Hospital; 🇺🇸 Providence, Rhode Island, United States