Actively Recruiting
Daily Nitrofurantoin Versus Bladder Electrofulguration Plus Daily Nitrofurantoin for Long-term Management of Chronic Cystitis in Women With Recurrent Urinary Tract Infections
Led by University of Texas Southwestern Medical Center · Updated on 2026-05-01
104
Participants Needed
2
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
U
University of Texas
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying women aged 18 to 85 who have a history of recurrent urinary tract infections (rUTIs) lasting at least one year. The trial aims to compare the effectiveness of daily Nitrofurantoin (NF) antibiotic alone versus a combination of bladder electrofulguration (EF) plus daily Nitrofurantoin for managing early stages of chronic cystitis, a type of bladder inflammation. This is a randomized, multicenter clinical trial involving participants diagnosed with stages 1 or 2 chronic cystitis based on office cystoscopy. Participants will be randomly assigned to one of two groups: one group will receive daily Nitrofurantoin antibiotic for 6 months, and the other will receive the same antibiotic treatment combined with bladder electrofulguration. The study will track the effects of these treatments over a 30-month period. Electrofulguration is a procedure used alongside the antibiotic to potentially improve treatment outcomes in early chronic cystitis. During the study, participants will attend 8 compensated visits at urology clinics to monitor their progress. Researchers will assess treatment success by tracking cystitis symptoms, urine cultures, antibiotic resistance, symptom scores, quality of life, and recurrence rates over 30 months. Safety and symptom assessments will be conducted regularly to understand the long-term effects of each treatment approach.
CONDITIONS
Brief Title
Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 85 years
- History of culture-documented uncomplicated recurrent urinary tract infections for at least 1 year
- Diagnosis of recurrent UTI defined as 3 or more symptomatic infections in 12 months or 2 or more in 6 months
- Currently free from UTI symptoms with a negative urine culture (<10^3 colony forming units per ml)
- Negative upper and lower urinary tract evaluation including pelvic exam, post-void residual less than 50 ml, and imaging to exclude kidney stones or other abnormalities
- Office cystoscopy confirming stage 1 or 2 chronic cystitis
- Likely to remain in geographic region for study duration
- ASA class II or less
You will not qualify if you...
- Current use of antibiotics at baseline for suppressive or non-urinary infections
- Use of self-start antibiotic therapy for urinary symptoms
- Recent or planned prophylactic antibiotic use within 3 months before or 12 months after enrollment
- Complicated urinary tract infections including neurogenic bladder, bladder augmentation, or urinary diversion
- Presence of urinary catheters
- Uncontrolled diabetes (HbA1c >9)
- Pregnancy
- Allergy or resistance to Nitrofurantoin
- Chronic lung or liver conditions preventing Nitrofurantoin use
- Chronic renal insufficiency (creatinine over 1.5 g/dl or GFR less than 40)
- History of chronic diarrhea needing regular therapy
- Psychosis, dementia, swallowing disorders, or inability to take Nitrofurantoin reliably at home
- Body mass index over 40
- Use of Uromune or other vaccines to reduce recurrent UTIs
- Participation in investigational product research within past 12 weeks
- Current phage therapy
- Diagnosis of interstitial cystitis
- Medical conditions requiring excessive fluid intake
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive daily Nitrofurantoin antibiotic prophylaxis for 6 months, with some also undergoing bladder electrofulguration as part of their treatment.
8 visits over 30 months including treatment and follow-up assessments
Duration - Up to 30 months after enrollment
Participants are monitored to assess the long-term effectiveness and safety of the treatment for up to 30 months after enrollment.
Included in the total of 8 visits over 30 months
Trial Site Locations
Total: 2 locations
1
The University of Kansas
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
M
Meghan Leak
P
Philippe Zimmern, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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