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

NCT04285320 | Unknown Phase 4

• 1 other identifier: 1565199
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Antibiotic bladder instillation; Intravesical antibiotic instillation; Oral suppressive therapy; Recurrent UTI

Outcome Measures

Primary Outcomes (1)

• The percentage of participants with urinary tract infections following treatment course

  To compare the percentage of women developing urinary tract infections during the 3 months following treatment between the two groups.

  Assessed starting immediately after the treatment is completed for a total of 3 months.

Secondary Outcomes (2)

• The rate of antibiotic resistance of pathogens in participants developing urinary tract infections after completing the treatment course.

  Assessed starting immediately after the treatment is completed for a total of 3 months

• the percentage of patients developing side effects of the 2 treatments

  From the date of randomization until the date of first documented side effect assessed up to 3 months after the treatment is completed in each arm

Study Arms (2)

Intravesical antibiotic instillation

ACTIVE COMPARATOR

Drug: Intravesical antibiotic instillation

Oral antibiotic suppressive therapy

ACTIVE COMPARATOR

Drug: Antibiotic oral suppressive therapy

Interventions

Intravesical antibiotic instillation DRUG

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

Intravesical antibiotic instillation

Antibiotic oral suppressive therapy DRUG

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)

Oral antibiotic suppressive therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-menopausal women with recurrent urinary tract infections (2 infections in a 6-month period or at least 3 infections in a 1-year period)
• Receiving estrogen vaginal therapy for 1 month prior to enrollment
• Able to come in to the office twice weekly for 3-4 weeks
• English speaking
• No allergy to at least one of the three antibiotics used for bladder instillations and at least one of the four antibiotics recommended for oral suppressive therapy.
• No uro-pathogen resistance to at least one of the three antibiotics used for bladder instillations and at least one of the four antibiotics recommended for oral suppressive therapy.

You may not qualify if:

• Allergy to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
• Recent Urine culture with pathogens resistant to all study antibiotics (Gentamicin, Tobramycin, Amikacin, Trimethoprim/sulfamethoxazole, Fosfomycin, Nitrofurantoin and Cephalexin)
• Renal failure (Creatinine clearance \<30ml/min)
• History of urinary retention
• History of genitourinary structural abnormalities

Sponsors & Collaborators

• Atlantic Health System: lead

Related Publications (1)

• Chernyak S, Salamon C. Intravesical Antibiotic Administration in the Treatment of Recurrent Urinary Tract Infections: Promising Results From a Case Series. Female Pelvic Med Reconstr Surg. 2020 Feb;26(2):152-154. doi: 10.1097/SPV.0000000000000810.

  PMID: 31990805 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Charbel Salamon, MD, MS

  Atlantic Health System - Morristown Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Sabatino, MPH

CONTACT

973-971-7361; caroline.sabatino@atlantichealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Urogynecology Division & Fellowship

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share