Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections
University of Texas Southwestern Medical Center
104 participants
Apr 30, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 Criteria18
- 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.
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Interventions
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06907199