Recruiting
Phase 1

NF vs. EF

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06907199

Conditions

Recurrent UTIs

Cystitis Recurrent

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Electrofulguration (EF)

Nitrofurantoin (NF)

Study Details

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.

Conditions

Recurrent UTIs

Cystitis Recurrent

Study ID

NCT06907199

Start date

Apr 6, 2026

Status verified date

Jul, 2026

Completion date

Jan 30, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Nitrofurantoin (NF) daily antibiotic prophylaxis

Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

experimental: Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)

Interventions

Electrofulguration (EF)

Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.

Nitrofurantoin (NF)

Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Primary outcome measure

  • Treatment of cystitis with NF vs EF+NF [ Time Frame: Baseline to 30 months after enrollment to completion of study ]

Central Contacts and Locations

Central contacts

Meghan Leak

214-645-8787utswuti@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Meghan B Leak

214-645-8787meghan.leak@utsouthwestern.edu

Jessica de Araujo Paula

214-645-8787jessica.dearaujopaula@utsouthwestern.edu

Principal Investigator:

Philippe Zimmern, MS

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • bladder fulguration
  • Nitrofurantoin
  • long-term managenent of cystitis
  • Recurrent UTI
  • chronic UTI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-23.