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

Overview

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.

Interventions

• Procedure Electrofulguration (EF)
  Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
• Drug Nitrofurantoin (NF)
  Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Primary outcome measures

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

Secondary outcome measures (7)

• No recurring cystitis [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate comparison of culture-documented breakthrough [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate of multi-drug resistant organisms [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate of non-urine culture [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate of behavior changes [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate of score differences in symptoms and quality of life [Time frame: Baseline to 30 months after enrollment to completion of study]
• Rate of UTI episodes [Time frame: Baseline to 30 months after enrollment to completion of study]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• The University of Kansas — Kansas City
• UT Southwestern Medical Center — Dallas

Identifiers

NCT: NCT06907199 · STU-2024-1187 · 1R01DK140224-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗