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Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections

NCT04285320 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-14

No results posted yet for this study

Summary

This is a research study that aims to determine if antibiotic bladder instillations (placing an antibiotic directly into the bladder) over several sessions at the office is a good option to prevent recurrent urinary tract infections, in comparison with oral suppression therapy (taking daily antibiotics in the form of pills by mouth). Oral antibiotic suppression therapy is currently the most common treatment route for recurrent urinary tract infections in post-menopausal women. The bladder antibiotic instillation may overcome the disadvantages of oral suppression therapy such as antibiotic resistance, certain side effects, and recurrence of infections after finishing the treatment course.

Conditions

  • Recurrent Urinary Tract Infection

Interventions

DRUG

Intravesical antibiotic instillation

Based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol: * Amikacin-30 mg in 60 ml of sterile water * Gentamycin-80mg in 60ml sterile water * Tobramycin-80 mg in 100 ml of sterile water

DRUG

Antibiotic oral suppressive therapy

In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile: * Trimethoprim daily (100 mg) * Trimethoprim/sulfamethoxazole daily (40 mg/200 mg) * Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg) * Nitrofurantoin monohydrate/macrocrystals daily (50 mg) * Nitrofurantoin monohydrate/macrocrystals daily (100 mg) * Cephalexin daily (125 mg) * Cephalexin daily (250 mg) * Fosfomycin every 10 days (3 grams)

Sponsors & Collaborators

  • Atlantic Health System

    lead OTHER

Principal Investigators

  • Charbel Salamon, MD, MS · Atlantic Health System - Morristown Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2023-04-30
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04285320 on ClinicalTrials.gov