Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change of defecation consistency
研究概览
简要总结
The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.
详细描述
Patients are selected according to the eligibility requirements. After obtaining informed consent off-label use and potential risks of sacral neuromodulation, all included patients and next of kin give written informed consent to the study.
At baseline, patients are randomized to one of the two predefined subgroups: either invasive sacral neuromodulation or non-invasive sacral neuromodulation. Clinical symptoms and outcome variables are compared regarding the beginning of non-invasive sacral neuromodulation or the implantation of the tined lead electrode. Patients are closely monitored within 6 months. Treatment success is evaluated in routine clinical check-ups (week 4/8/12 and 24) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 and 24 weeks of treatment.
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
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 2-17 years
- •informed consent
- •chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling despite underlying diseases such as slow-transit constipation, rectal evacuation disorders or Hirschsprung's disease.
- •refractory to conventional treatment in an appropriate weight-adapted application (training for bowel movements, lifestyle changes, pelvic floor training, pharmacological options)
- •in cases of Hirschsprung's disease: diagnosis confirmed histologically by rectal biopsies and in case of resection of an aganglionic segement: period between surgery and SNM at least 1 year
- •in cases of anorectal malformation or mechanical obstruction: post-surgical status: period between surgery and SNM at least 1 year
排除标准
- •metabolic, inflammatory, and hormonal causes for chronic constipation
- •toxic megacolon or further emergencies, which must be treated surgically
- •sacral fractures or substantial differences in the sacral anatomy
- •inflammatory bowel disorders
- •rectal prolapse
- •neuronal malignancies under medical and radiation therapy
结局指标
主要结局
Change of defecation consistency
时间窗: Baseline and 12 and 24 weeks after start of therapy
Defecation consistency is measured daily by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). Definition of success: change of at least 2 points within the scale of 1-7
Change of episodes of abdominal pain
时间窗: Baseline and 12 and 24 weeks after start of therapy
Abdominal pain is recorded in number of episodes per week. Its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain). Definition of success: reduction by at least 50% of episodes per week
Change of episodes of fecal incontinence
时间窗: Baseline and 12 and 24 weeks after start of therapy
Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week
Change of defecation frequency
时间窗: Baseline and 12 and 24 weeks after start of therapy
Defecation frequency is measured by number of bowel movements per week. Definition of success: doubling of episodes per week to at least 3 or more bowel movements per week
次要结局
- Change of proprioception(Baseline and 12 and 24 weeks after start of therapy)
- Change of Quality of Life(Baseline and 12 and 24 weeks after start of therapy)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(Baseline and 12 and 24 weeks after start of therapy)
- Episodes of urinary incontinence(Baseline and 12 and 24 weeks after start of therapy)
研究者
Dr. med. Sonja Diez
Principal Investigator, M.D.
Friedrich-Alexander-Universität Erlangen-Nürnberg