Daily nitrofurantoin versus bladder electrofulguration plus daily nitrofurantoin for women with recurrent UTIs
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
This trial will test whether adding bladder electrofulguration to six months of daily nitrofurantoin helps women with recurrent cystitis have fewer infections than six months of nitrofurantoin alone.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | Female |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 2 sites (Kansas City, Kansas and 1 other locations) |
| Trial ID | NCT06907199 on ClinicalTrials.gov |
What this trial studies
This randomized, multicenter Phase 1 study will enroll 104 women aged 18–85 with at least a one-year history of recurrent uncomplicated UTIs and office cystoscopy showing stage 1 or 2 chronic cystitis. Participants are randomized to receive six months of daily nitrofurantoin alone or electrofulguration of the bladder plus six months of daily nitrofurantoin, with follow-up visits at one of two sites (UT Southwestern or University of Kansas). The protocol includes eight compensated clinic visits over 30 months to monitor symptoms, urine cultures, and cystoscopic findings. The trial aims to compare recurrence rates and clinical response between the two approaches in early-stage chronic cystitis.
Who should consider this trial
Good fit: Women aged 18–85 with culture-documented recurrent uncomplicated UTIs for at least one year, currently asymptomatic with a negative urine culture, office cystoscopy showing stage 1 or 2 chronic cystitis, and no significant upper urinary tract abnormalities are ideal candidates.
Not a fit: Patients with complicated UTIs, significant pelvic organ prolapse, high post-void residuals, upper tract pathology, ongoing antibiotic use at baseline, or who cannot attend the study visits are unlikely to benefit from or qualify for this protocol.
Why it matters
Potential benefit: If successful, the combined electrofulguration plus nitrofurantoin approach could lower UTI recurrence and improve long-term symptom control for women with early-stage chronic cystitis.
How similar studies have performed: Long-term nitrofurantoin prophylaxis is an established strategy for preventing recurrent UTIs, while bladder electrofulguration has limited, mostly small-series evidence, so combining the two is relatively novel with modest prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas and 1 other locations
- The University of Kansas — Kansas City, Kansas, United States (Not_yet_recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Philippe Zimmern, M.D. — University of Texas Southwestern Medical Center
- Study coordinator: Meghan Leak
- Email: utswuti@utsouthwestern.edu
- Phone: 214-645-8787
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.