A Randomized, Double-blind, Placebo-controlled Trial Examining the Effect of Nitrofurantoin Prophylaxis in Women Performing Clean Intermittent Self-catheterization (CISC) After Surgery for Urinary Incontinence and/or Pelvic Organ Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation
研究概览
简要总结
Urinary tract infection (UTI) is the most common complication after surgery for prolapse or urinary incontinence. UTIs are painful and have the potential to turn into kidney infections. We are asking women who self-catheterize after surgery to try either an antibiotic or a placebo pill so we can see if we can prevent UTIs without causing side effects.
This study will not require any additional visits or blood draws. You will be asked to answer some questions, keep a brief diary of your experience, and immediately report any symptoms of a UTI to your doctor.
详细描述
Abstract:
Specific aim: to determine if extended release nitrofurantoin antibiotic prophylaxis administered to patients performing clean intermittent self-catheterization (CISC) after pelvic organ prolapse and/or urinary incontinence surgery decreases the incidence of symptomatic urinary tract infection (UTI) compared with placebo.
Study Design: Randomized double-blind placebo-controlled trial.
Methods: Consented patients who undergo urogenital surgery and fail their post-operative voiding trial will be randomized to either extended release nitrofurantoin 100mg or an identical appearing placebo capsule to be taken daily while performing CISC and for three subsequent days after stopping CISC. Catheterized urine specimens will be sent for culture and sensitivity when women report symptoms consistent with cystitis. Symptomatic UTI will be defined using strict culture-based definitions. We anticipate that the study will end within 6 weeks of starting CISC.
Data Analysis: Primary and secondary outcomes will be evaluated with Student t test and Fisher exact test.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who fail a post-operative voiding trial and are willing to learn clean intermittent self-catheterization (CISC) prior to discharge from the hospital
排除标准
- •Known drug allergy to nitrofurantoin
- •A history of renal insufficiency
- •Renal transplant
- •Renal nephropathy
- •A recent history of more than 3 Urinary Tract Infections (UTIs) per year
- •Known immunocompromised condition (organ transplant, chemotherapy for cancer or arthritis, autoimmune diseases (lupus etc)).
研究组 & 干预措施
Arm 1: Nitrofurantoin Group
extended release nitrofurantoin 100mg to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
干预措施: Nitrofurantoin (Drug)
Arm 2: Placebo Group
identical appearing placebo capsule to be taken daily while performing clean intermittent self-catheterization (CISC) and for three more days after stopping CISC
干预措施: Placebo (Drug)
结局指标
主要结局
Frequency of Symptomatic UTI's Confirmed With a Positive Urine Culture Within 6 to 8 Weeks After CISC Teaching and Implementation
时间窗: 6 to 8 weeks after surgery
Participants are to be assessed for UTI systems and f/u urine culture routine over a period of 6 to 8 weeks after CISC teaching and implementation.
次要结局
- Frequency of Adverse Events Related to Daily Nitrofurantoin Exposure Such as Nausea, Diarrhea, C. Difficile Colitis(6 weeks after surgery)
- Time (Days After Surgery) to Development of Symptomatic, Culture Documented UTI(6 weeks after surgery)
- Frequency of Adverse Events Related to CISC Such as Urethral Pain, Irritative Voiding Symptoms, Hematuria(6 weeks after surgery)
- Frequency of Urine Cultures Positive for Organism Strains That Are Resistant to Nitrofurantoin and Other Commonly Used Antibiotics.(6 weeks after surgery)
- Adherence to CISC(6 weeks after surgery)
- Patient Perceptions Regarding CISC(6 weeks after surgery)
研究者
Gary Sutkin
Physician
University of Pittsburgh