A Controlled Randomized, Physician Blinded Study to Assess Isolated Uro-therapy vs. Urotherapy With Constipation Treatment for Patients With Lower Urinary Tract Dysfunction (LUTD) Not Meeting ROME-III Constipation Criteria
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.
研究概览
简要总结
Constipation treatment has been found to ameliorate symptoms in some patients with lower urinary tract dysfunction (including day time or combined day time/night time urinary incontinence). This study aims to explore if treatment of patients without overt constipation (As defined by the ROME III criteria) will also respond to anti-constipation treatment with reduction of their urinary tract symptoms. Assessment of severity and response of lower urinary tract dysfunction will be based on the Vancouver NULTD/DES questionnaire.
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
- Single (Investigator)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 5-17 years at time of signing of informed consent.
- •Lower urinary tract dysfunction (LUTD)-daytime/daytime and nighttime urinary incontinence as defined by a score of >11 on the Vancouver Questionnaire .
- •Do not meet Rome III criteria for functional constipation.
排除标准
- •Inability to provide signed informed consent.
- •Inability to comply with the study protocol.
- •Neurogenic bladder
- •Attention Deficit Disorder (ADD or ADHD) on medical treatment.
- •Known significant sacral, perineal, or other congenital or surgical defect.
- •Known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis)
- •Patient taking medicinal drugs which can cause urinary incontinence or constipation.
研究组 & 干预措施
Urotherapy + Constipation Treatment
This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
干预措施: Urotherapy (Behavioral)
Urotherapy alone
This group will receive standard behavioral urotherapy alone.
干预措施: Urotherapy (Behavioral)
Urotherapy + Constipation Treatment
This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
干预措施: Constipation behavioral therapy (Behavioral)
Urotherapy + Constipation Treatment
This group will be treated with standard behavioral urotherapy in addition to receiving active stool softening with PEG3350 and standard constipation instruction.
干预措施: polyethylene glycol 3350 (Drug)
结局指标
主要结局
Complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response at the end of intervention.
时间窗: 14 weeks
次要结局
- Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response in patient subgroups with fecal loading compared to those without fecal loading.(14 weeks)
- Sustained Response - Number of participants with complete (Vancouver score - ≤90% of screening value) or Partial (Vancouver score ≤ 50% screening value) response 12 weeks after intervention has ended.(26 weeks)
- Number of participants with adverse effects(14 weeks)
研究者
Noam Zevit
Pediatric Gastroenterologist
Rabin Medical Center