Design and methodology of a randomized clinical trial of prolonged daily antibiotic suppression with and without fulguration for uncomplicated recurrent urinary tract infections in women

ObjectiveRecurrent urinary tract infections (rUTIs) significantly decrease quality of life and antibiotics are becoming increasingly less effective due to antimicrobial resistance. Alternative effective treatment strategies are urgently needed for rUTIs. Prior studies have indicated that women can experience resolved or improved rUTI following electrofulguration (EF). To further investigate these findings, we report on the design and methodology behind a randomized trial examining two treatment arms: standard prolonged antibiotic treatment with nitrofurantoin (NF) alone or in combination with EF. Patients and MethodsThe aim of this randomized trial is to determine, at two institutions, the efficacy of two interventions for rUTI associated with early stages of chronic cystitis (stages 1 and 2): conventional 6 months low-dose (100mg) NF daily antibiotic suppression alone (NF) or conventional NF with EF (EF + NF). The study is also designed to analyze changes in the urinary microbiomes in the two different treatment arms and to determine the durability of clinical outcomes in both treatment arms at 2 years after the end of each intervention. The primary outcomes will be obtained from 6 to 18 months, as well as 18 - 30 months following completion of the original 6-month intervention. Failure is defined based on UTI symptoms documented by a validated questionnaire with a documented urine culture confirming a bacterial strain at each UTI episode following the end of the 6-month intervention. ConclusionsThis randomized trial is designed to examine the efficacy and durability of treating women with rUTIs using the standard of care of NF alone, or an EF procedure with NF.