The Role of Active Administration of Peristeen Bowel Evacuation for the Management of Urinary Tract Infection in Patients With Neurogenic Bladder: a Prospective, Explorative Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in nitrite and leukocyte esterase
研究概览
简要总结
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients with the diagnosis of neurogenic bladder.
详细描述
This study investigates whether active use of transanal irrigation (Peristeen®) effectively manages urinary tract infection among patients diagnosed with neurogenic bladder. It is a prospective exploratory pilot study, and the participants will be asked to perform transanal irrigation twice weekly for 12 weeks (three months). At each visit, including baseline, the study endpoints will be assessed by basic urinalysis, KUB imaging, Seoul Fecal Scoring, and a survey (Korean Neurogenic Bowel Score).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages, 5 to 18, and are diagnosed with neurogenic bladder.
- •Use CIC (CIC: Clean Intermittent Catheterization) daily to empty the bladder.
- •A recent history of fecal incontinence within the last 3 months
- •More than two episodes of urinary tract infection and/ or pyuria within the last 6 months
排除标准
- •An anatomical abnormality of the bladder neck.
- •Known intractable origin of bacteriuria such as urolithiasis (kidney stone) or nonfunctional renal segment.
- •Received bladder augmentation surgery
- •Patient without completion of toilet training
- •Either received following treatment diagnosed according to Peristeen® product safety guideline:
- •Anorectal malformation
- •Colorectal cancer
- •Endoscopic polyp removal surgery in 3 months
- •Ischemic colitis
- •Acute inflammatory bowel disease
- •Acute intestinal diverticulum.
- •Radiotherapy to the colon
- •Long-term corticosteroid usage
结局指标
主要结局
Change in nitrite and leukocyte esterase
时间窗: 12 weeks
Either complete or partial reduction of nitrite and leukocyte esterase on the
次要结局
- Korean Neurogenic Bowel Dysfunction Score(Baseline, 4 weeks, 8 weeks, 12 weeks)
- Safety efficacy of Peristeen Transanal Irrigation(4 weeks, 8 weeks, 12 weeks)
- Seoul Fecal Scoring(Baseline, 4 weeks, 8 weeks, 12 weeks)
研究者
Kwanjin Park
Associate Professor
Seoul National University Hospital