Intravesical Gentamicin to Prevent Recurrent UTI

Last updated: August 14, 2025
Sponsor: Women and Infants Hospital of Rhode Island
Overall Status: Active - Recruiting

Phase

4

Condition

Urinary Tract Infections

Treatment

Gentamicin

Nitrofurantoin

Clinical Study ID

NCT06332781
2126175
  • Ages > 40
  • Female
  • Accepts Healthy Volunteers

Study 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)

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Postmenopausal

  • 2 UTIs in 6 months

  • desire to start antibiotic prophylaxis to prevent UTIs

Exclusion

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 thesame family including but not limited to: amikacin, kanamycin, neomycin,paromomycin, streptomycin, tobramycin.

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Gentamicin
Phase: 4
Study Start date:
April 28, 2025
Estimated Completion Date:
December 31, 2025

Study 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).

Connect with a study center

  • Women & Infants Hospital

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

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