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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Electrofulguration (EF)
  • Nitrofurantoin (NF)

Treatment groups

104 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Texas Southwestern Medical Center

Lead sponsor

University of Texas

Collaborator

National Institutes of Health (NIH)

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator