Clinical trial NCT06907199: Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
Official title: A Multicentric Randomized Trial of Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for the Long-term Management of Cystitis in Women With Recurrent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Recurrent UTIs
Cystitis Recurrent
Keywords: bladder fulguration
Nitrofurantoin
long-term managenent of cystitis
Recurrent UTI
chronic UTI
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas
name: National Institutes of Health (NIH)
First posted: 2025-04-02
Enrollment: 104
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a study for women age 18 -85 with a well-documented history of rUTI (recurrent urinary tract infection) for at least one year. This randomized multicentric clinical trial will determine the efficacy of conventional 6 months Nitrofurantoin (NF) daily antibiotic prophylaxis alone versus electrofulguration (EF) associated with a 6 months NF daily antibiotic prophylactic course for early stages of chronic cystitis (stages 1 and 2) as determined on office cystoscopy.

This study will ask the participant (n=104) to return to the Urology clinic at UT Southwestern Medical Center (n=52) or The University of Kansas Medical Center (n=52) for a total of 8 compensated visits throughout 30 months after the start of this randomized trial to make sure that the treatment worked well for them.

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.

Primary outcomes:
measure: Treatment of cystitis with NF vs EF+NF
timeFrame: Baseline to 30 months after enrollment to completion of study
Secondary outcomes:
measure: No recurring cystitis
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate comparison of culture-documented breakthrough
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate of multi-drug resistant organisms
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate of non-urine culture
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate of behavior changes
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate of score differences in symptoms and quality of life
timeFrame: Baseline to 30 months after enrollment to completion of study
measure: Rate of UTI episodes
timeFrame: Baseline to 30 months after enrollment to completion of study
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas
state: Kansas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
References: