Status:
UNKNOWN
Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections
Lead Sponsor:
Atlantic Health System
Conditions:
Recurrent Urinary Tract Infection
Eligibility:
FEMALE
Phase:
PHASE4
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 re...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04285320
Start Date
March 1 2021
End Date
April 1 2023
Last Update
January 14 2021
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