NCT06907199 Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
| NCT ID | NCT06907199 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Recurrent UTIs |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2026-04-06 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 104 participants in total. It began in 2026-04-06 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Philippe Zimmern, M.D.
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06907199 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 85 Years, studying Recurrent UTIs. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06907199 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06907199 currently recruiting?
Yes, NCT06907199 is actively recruiting participants. Contact the research team at utswuti@utsouthwestern.edu for enrollment information.
Where is the NCT06907199 trial being conducted?
This trial is being conducted at Kansas City, United States, Dallas, United States.
Who is sponsoring the NCT06907199 clinical trial?
NCT06907199 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Philippe Zimmern, M.D. at University of Texas Southwestern Medical Center. The trial plans to enroll 104 participants.