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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
The University of Kansas
Kansas City, Kansas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Treatment of cystitis with NF vs EF+NF
Rate of culture documented symptomatic UTIs following the completion of each 6-month study arm intervention. Specifically, from 6 to 18 months (first year) after the completion of the original intervention and, 18 to 30 months (second year).
Time frame: Baseline to 30 months after enrollment to completion of study
No recurring cystitis
Comparison of patient characteristics between the two enrolling institutions.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate comparison of culture-documented breakthrough
Rate of culture-documented breakthrough UTIs between the two treatment arms.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate of multi-drug resistant organisms
Rate of urine cultures showing multi-drug resistant organisms in each treatment arm.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate of non-urine culture
Rate of non-urine culture documented symptomatic UTI episodes for 12 months and 24 months following end of treatment arms, as determined by the Urinary Tract Infection Symptom Assessment (UTISA) (a total score of 3 or higher, or any individual score of 2 or 3) between the two treatment arms.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate of behavior changes
Rate of behavior changes in both groups (fluid increases or use of non-antibiotic therapies, e.g., cranberry, D-mannose, urinary analgesics, hormonal therapy) in each treatment arm.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate of score differences in symptoms and quality of life
Rate of score differences in patient symptoms and quality of life assessments using validated questionnaires- the Urinary Tract Infection Symptom Assessment (UTISA), Urinary Distress Inventory, Short Form (UDI-6), and Quality of Life scale (QoL) by Visual Analogue Scale (VAS) between both treatment arms.
Time frame: Baseline to 30 months after enrollment to completion of study
Rate of UTI episodes
Rate of UTI episodes (after first and second year of the completion of the intervention) compared to the rate of UTI episodes prior to the start of study
Time frame: Baseline to 30 months after enrollment to completion of study