The goal of this clinical trial is to learn if the drug Nitrofurantoin (NF) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (EF) and Nitrofurantoin (NF) daily antibiotic.
Females 18 to 85 years old with at least a 1-year history of culture documented uncomplicated rUTI.
Diagnosis of rUTI, defined as ≥ 3 symptomatic UTIs in 12 months or ≥ 2 in 6 months.
Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire and negative urine culture (<10^3 colony forming units per ml of urine).
A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than or equal to stage 2), measurement of post-void residual (less than 50 ml), and imaging (which may include renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum.
Patients on antibiotics at baseline (i.e., suppressive therapy or antibiotic therapy for non-urinary infections).
Patients on self-start therapy (i.e., taking antibiotics upon start of urinary symptoms concerning for UTI).
Patients on prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months.
Complicated UTIs, including neurogenic bladder condition (i.e., multiple sclerosis, Parkinson's disease, spinal cord injury), bladder augmentation, or urinary diversion.
Parallel
Electrofulguration (EF)
Procedure/SurgeryNitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF)
DrugNitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Treatment of cystitis with NF vs EF+NF
Rate of culture documented symptomatic UTIs following the completion of each 6-month study arm intervention. Specifically, from 6 to 18 months (first year) after the completion of the original intervention and, 18 to 30 months (second year).
No recurring cystitis
Comparison of patient characteristics between the two enrolling institutions.
Rate comparison of culture-documented breakthrough
Rate of culture-documented breakthrough UTIs between the two treatment arms.
Rate of multi-drug resistant organisms
Rate of urine cultures showing multi-drug resistant organisms in each treatment arm.
Rate of non-urine culture
Rate of non-urine culture documented symptomatic UTI episodes for 12 months and 24 months following end of treatment arms, as determined by the Urinary Tract Infection Symptom Assessment (UTISA) (a total score of 3 or higher, or any individual score of 2 or 3) between the two treatment arms.
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University of Texas Southwestern Medical Center
Lead sponsor
University of Texas
Collaborator
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
