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
University of Texas Southwestern Medical Center
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.
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…
Eligibility
- Age range
- 18–85 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- ProcedureElectrofulguration (EF)
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
- DrugNitrofurantoin (NF)
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
Locations (2)
- The University of KansasKansas City, Kansas
- UT Southwestern Medical CenterDallas, Texas