NL-OMON56214招募中不适用
Evaluation of the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence. The SENS-U trial - The SENS U trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 15（—）
入选标准
- •Age >= 6 years and < 16 years
- •Presenting with functional daytime urinary incontinence according to previous
- •definition ( >= one episode a month , >= 3 months)
- •Diagnosed with overactive bladder, dysfunctional voiding or underactive
- •bladder with or without recurrent urinary tract infections according ICCS
- •criteria/classification
- •Eligible for urotherapy/ bladder training as the treatment of choice by the
- •No current urinary tract infection (UTI) at the start of the study
排除标准
- •History of congenital urogenital anomalies except for successfully treated
- •mild infravesical obstruction (meatal stenosis, mild urethral valves) < 3
- •months before inclusion
- •History of neurological underlying disease
- •Untreated or treated but persisting functional constipation according to Rome
- •IV criteria at the start of the study < 6 months before inclusion.
- •Recurrent culture proven UTI (less than 3 months before start of the study or
- •not under control by prophylactic antibiotics)
- •Previous urotherapy/ bladder training within 6 months of start of the study
- •Adipositas preventing accurate measurement by the SENS-U as defined as a BMI
- •> 95th percentile according to age/gender.
- •Skin problems in the suprapubic area that are incompatible with the SENS-U
- •Developmental and intellectual disabilities or severe behavioural and social
- •problems that are incompatible with protocolled urotherapy treatment based on
- •the history and opinion of the clinician/ urotherapist.
研究者
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