Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
NCT ID: NCT06907199
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
104 participants
INTERVENTIONAL
2026-01-31
2029-01-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)
Electrofulguration (EF)
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Nitrofurantoin (NF) daily antibiotic prophylaxis
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Nitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Interventions
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Electrofulguration (EF)
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
85 Years
FEMALE
No
Sponsors
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University of Texas
OTHER
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Philippe Zimmern
Professor of Urology
Locations
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The University of Kansas
Kansas City, Kansas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Colby Souders, MD
Role: primary
Meghan B Leak
Role: primary
Jessica de Araujo Paula
Role: backup
Other Identifiers
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STU-2024-1187
Identifier Type: -
Identifier Source: org_study_id