NCT06332781

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 28, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

December 13, 2023

Last Update Submit

April 13, 2026

Conditions

Recurrent Uti

Outcome Measures

Primary Outcomes (3)

  • Assess feasibility of trial recruitment

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

    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

    3 months

  • Examine trial retention

    compare the proportion of participants retained in each group

    3 months

Secondary Outcomes (7)

  • culture-proven UTIs

    3 months

  • Patient reported outcome measures

    6 weeks, 3 months

  • Patient reported outcome measures

    6 weeks, 3 months

  • Patient reported outcome measures

    6 weeks, 3 months

  • Patient reported outcome measures

    6 weeks, 3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • urobiome analysis

    6 weeks, 3 months

  • urobiome analysis

    6 weeks, 3 months

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care

Drug: Nitrofurantoin

Experimental

EXPERIMENTAL

Gentamicin

Drug: Gentamicin

Interventions

GentamicinDRUG

administered via bladder

Experimental
NitrofurantoinDRUG

administered PO

Standard of Care

Eligibility Criteria

Age40 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspostmenopausal women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal
  • UTIs in 6 months
  • desire to start antibiotic prophylaxis to prevent UTIs

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women & Infants Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

GentamicinsNitrofurantoin

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydratesNitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

March 27, 2024

Study Start

April 28, 2025

Primary Completion

September 30, 2025

Study Completion

March 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)