NCT06907199 · University of Texas Southwestern Medical Center
Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
- 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.
Where
- Kansas City, Kansas
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations