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

January 13, 2021 updated by: charbel salamon, Atlantic Health System

Intravesical Antibiotic Instillations Versus Oral Suppression for the Treatment of Recurrent Urinary Tract Infections in Post-menopausal Women

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators aim to determine the effectiveness of intra-vesical antibiotic instillations for the prophylactic treatment of recurrent urinary tract infections in menopausal women in comparison with oral suppressive therapy. This is a parallel un-blinded randomized-controlled trial. the investigators will randomize post-menopausal women with recurrent urinary tract infections to either receive 6-8 intra-vesical antibiotic instillations at the office or to receive 3 months of oral antibiotic suppressive therapy.

In the bladder instillation arm, 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

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) All medications used in this study are approved by the FDA to treat urinary tract infections.

Participants will be followed for total of 3 months after finishing either treatment course by only reviewing their medical records to collect data regarding development of urinary tract infections after treatment.

Primary endpoint/outcome:

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

Secondary endpoints/outcomes:

  • To compare the rate of antibiotic resistance of isolated pathogens after intravesical antibiotic instillation vs. oral antibiotic suppressive therapy
  • To compare side effects of the two treatment modalities

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravesical antibiotic instillation
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
Active Comparator: Oral antibiotic suppressive therapy
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of participants with urinary tract infections following treatment course
Time Frame: Assessed starting immediately after the treatment is completed for a total of 3 months.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of antibiotic resistance of pathogens in participants developing urinary tract infections after completing the treatment course.
Time Frame: Assessed starting immediately after the treatment is completed for a total of 3 months
To compare the rate of antibiotic resistance of isolated pathogens when participants develop a urinary tract infection during the 3 months follow up period after intra-vesical antibiotic instillation vs. oral antibiotic suppressive therapy. the percentage of antibiotics on the susceptibility list of urine cultures will be compared between participants developing urinary tract infection in each group during the 3 months follow-up period after completing the treatment.
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
Time Frame: 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
To compare the percentage of patients developing side effects between the two treatment modalities. At their routine follow up visits patients will be asked about whether or not they developed side effects and the type and severity of side effects of the treatment received. The percentage of patients developing side effects (per type and severity) in each arm will be compared.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Investigators

  • Principal Investigator: Charbel Salamon, MD, MS, Atlantic Health System - Morristown Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

February 17, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1565199

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrent Urinary Tract Infection

Clinical Trials on Intravesical antibiotic instillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe