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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 4
- 主要终点
- Treatment of cystitis with NF vs EF+NF
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Nitrofurantoin (NF) daily antibiotic prophylaxis
Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.
干预措施: Nitrofurantoin (NF) (Drug)
Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)
干预措施: Electrofulguration (EF) (Procedure)
Nitrofurantoin (NF) daily antibiotic prophylaxis plus electrofulguration (EF)
干预措施: Nitrofurantoin (NF) (Drug)
结局指标
主要结局
Treatment of cystitis with NF vs EF+NF
时间窗: Baseline to 30 months after enrollment to completion of study
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).
次要结局
- No recurring cystitis(Baseline to 30 months after enrollment to completion of study)
- Rate comparison of culture-documented breakthrough(Baseline to 30 months after enrollment to completion of study)
- Rate of multi-drug resistant organisms(Baseline to 30 months after enrollment to completion of study)
- Rate of non-urine culture(Baseline to 30 months after enrollment to completion of study)
- Rate of behavior changes(Baseline to 30 months after enrollment to completion of study)
- Rate of score differences in symptoms and quality of life(Baseline to 30 months after enrollment to completion of study)
- Rate of UTI episodes(Baseline to 30 months after enrollment to completion of study)
研究者
Philippe Zimmern
Professor of Urology
University of Texas Southwestern Medical Center