Daily Nitrofurantoin Versus Bladder Fulguration Plus Daily Nitrofurantoin for Women With Recurrent Urinary Tract Infections
Purpose
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.
Conditions
- Recurrent UTIs
- Cystitis Recurrent
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- Female
- Accepts 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 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. - 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Nitrofurantoin (NF) daily antibiotic prophylaxis |
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months. |
|
|
Experimental Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF) |
|
Recruiting Locations
UT Southwestern Medical Center
Dallas, Texas 75390
Dallas, Texas 75390
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
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.