Overview
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.
Description
This is a study for women age 18 -85 with a well-documented history of rUTI (recurrent urinary tract infection) for at least one year. This randomized multicentric clinical trial will determine the efficacy of conventional 6 months Nitrofurantoin (NF) daily antibiotic prophylaxis alone versus electrofulguration (EF) associated with a 6 months NF daily antibiotic prophylactic course for early stages of chronic cystitis (stages 1 and 2) as determined on office cystoscopy.
This study will ask the participant (n=104) to return to the Urology clinic at UT Southwestern Medical Center (n=52) or The University of Kansas Medical Center (n=52) for a total of 8 compensated visits throughout 30 months after the start of this randomized trial to make sure that the treatment worked well for them.
Eligibility
Inclusion Criteria:
- 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.
- Office cystoscopy documenting stages 1 or 2 of chronic cystitis.
- Likely to stay in the geographic region for the duration of the study.
- ASA class II or less.
Exclusion Criteria:
- 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.
- Patients with urinary catheters (including indwelling Foley, intermittent catheterization, and suprapubic catheters).
- Uncontrolled diabetes (HbA1c \>9).
- Pregnancy
- Allergy or resistance to Nitrofurantoin.
- Chronic lung or liver condition precluding the use of Nitrofurantoin, including abnormal chest X ray or elevated liver function tests.
- Chronic renal insufficiency (creatinine over 1.5 g/dl or GFR less than 40) precluding the use of Nitrofurantoin.
- History of chronic diarrhea requiring regular therapy.
- Patients with psychosis, dementia, swallowing disorders, or any other ability to take Nitrofurantoin reliably at home.
- BMI over 40.
- Use of Uromune or other vaccine approaches to reduce rUTI episodes
- Participation in a research study involving an investigational product in the past 12 weeks.
- Patients receiving phage therapy.
- Current diagnosis of interstitial cystitis.
- Patients with medical conditions requiring excessively large amounts of fluid intake.
