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Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections | Clinical Trials | Clareo Health

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

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

NCT06907199•University of Texas Southwestern Medical Center

View on ClinicalTrials.gov

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

Age

18 - 85 years

Sex

FEMALE

Healthy Volunteers

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.
+8 more criteria

Locations (2)

The University of Kansas

Kansas City, Kansas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Key Dates

Start Date

January 31, 2026

Primary Completion Date

July 1, 2028

Completion Date

January 30, 2029

Last Updated

December 19, 2025

Enrollment

104

ESTIMATED participants

Conditions

Recurrent UTIsCystitis Recurrent

Interventions

Electrofulguration (EF)

PROCEDURE

Nitrofurantoin (NF)

DRUG

Contacts

Meghan Leak

CONTACT

214-645-8787 utswuti@utsouthwestern.edu