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Completed

NCT Number: NCT06332781

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)

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Key information

Conditions

Recurrent Uti Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Women & Infants Hospital

Providence, Rhode Island, 02903, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gentamicin

Drug

administered via bladder

Nitrofurantoin

Drug

administered PO

Primary outcomes

  1. Assess feasibility of trial recruitment

    Time frame: 3 months

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

  2. Examine treatment compliance

    Time frame: 3 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

  3. Examine trial retention

    Time frame: 3 months

    compare the proportion of participants retained in each group

Secondary outcomes

  1. culture-proven UTIs

    Time frame: 3 months

  2. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    UTI Symptom Assessment

  3. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    recurrent UTI symptom scale

  4. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    recurrent UTI impact questionaire

  5. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    short-form-36

  6. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    general anxiety disorder-7

  7. Patient reported outcome measures

    Time frame: 6 weeks, 3 months

    patient health questionnaire

Other outcomes

  1. urobiome analysis

    Time frame: 6 weeks, 3 months

    bacterial presence

  2. urobiome analysis

    Time frame: 6 weeks, 3 months

    antimicrobial resistance gene presence

Sponsors and collaborators

Lead sponsor

Women and Infants Hospital of Rhode Island

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 27, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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