Study for Recurrent Urinary Tract Infections in Women

This study is for women aged 18 to 85 who experience frequent urinary tract infections (UTIs). It aims to compare two ways to prevent these infections: taking the antibiotic Nitrofurantoin daily for six months, or having a procedure called electrofulguration (EF) along with taking Nitrofurantoin daily for six months. Electrofulguration is a procedure that uses heat to destroy abnormal tissue. The main goal is to see which approach is more effective in treating cystitis (bladder inflammation) over 30 months. To join, you must have a history of at least three UTIs in 12 months, or two in six months, and currently be free from a UTI.

Study design
This is an interventional study involving 104 women, comparing two treatment approaches for recurrent UTIs.
What's involved
You would return to a Urology clinic for a total of 8 visits over 30 months after the study begins.
Compensation
You will receive compensation for your visits.
Follow-up
Participants will be followed for 30 months after enrollment to assess treatment effectiveness.

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NCT06907199

Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections

Recruiting
PHASE1Ages 18–85InterventionalTreatment
University of Texas Southwestern Medical Center
~104 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Electrofulguration (EF)Nitrofurantoin (NF)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment of cystitis with NF vs EF+NF
Measured over Baseline to 30 months after enrollment to completion of study
Recurrent UTIs
Cystitis Recurrent
2 sites across 2 states
Kansas1
Texas1
  • Philippe Zimmern, M.D. · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Treatment of cystitis with NF vs EF+NFBaseline to 30 months after enrollment to completion of study

    Rate of culture documented symptomatic UTIs following the completion of each 6-month study arm intervention. Specifically, from 6 to 18 months (first year) after the completion of the original intervention and, 18 to 30 months (second year).