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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Electrofulguration (EF)
  Nitrofurantoin (NF) daily antibiotic prophylaxis for 6 months plus Electrofulguration.
• Препарат Nitrofurantoin (NF)
  Nitrofurantoin (NF) daily antibiotic prophylaxis given daily for 6 months.

Первичные конечные точки

• Treatment of cystitis with NF vs EF+NF [Срок оценки: Baseline to 30 months after enrollment to completion of study]

Вторичные конечные точки (7)

• No recurring cystitis [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate comparison of culture-documented breakthrough [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate of multi-drug resistant organisms [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate of non-urine culture [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate of behavior changes [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate of score differences in symptoms and quality of life [Срок оценки: Baseline to 30 months after enrollment to completion of study]
• Rate of UTI episodes [Срок оценки: Baseline to 30 months after enrollment to completion of study]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• The University of Kansas — Kansas City
• UT Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT06907199 · STU-2024-1187 · 1R01DK140224-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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