Daily nitrofurantoin versus bladder electrofulguration plus daily nitrofurantoin for women with recurrent UTIs

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• The University of Kansas
  Kansas City, Kansas, United States Not yet 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.