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

NCT ID: NCT04285320

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2023-04-30

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.

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

Conditions

Recurrent Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intravesical antibiotic instillation

Group Type: ACTIVE_COMPARATOR

Intravesical antibiotic instillation

Intervention Type: 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

Oral antibiotic suppressive therapy

Group Type: ACTIVE_COMPARATOR

Antibiotic oral suppressive therapy

Intervention Type: 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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Atlantic Health System

OTHER

Sponsor Role: lead

Responsible Party

charbel salamon

Director, Urogynecology Division & Fellowship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charbel Salamon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Atlantic Health System - Morristown Medical Center

Central Contacts

Caroline Sabatino, MPH

Role: CONTACT

caroline.sabatino@atlantichealth.org

973-971-7361

References

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.

Reference Type: BACKGROUND

PMID: 31990805 (View on PubMed)

Other Identifiers

1565199

Identifier Type: -

Identifier Source: org_study_id