Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Urinary Tract Infection
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Only males
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 tria...
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
Tracking Information
- NCT #
- NCT04285320
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Charbel Salamon, MD, MS Atlantic Health System - Morristown Medical Center