Anorectal Malformations, Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease, Sacral Dysgenesis
Conditions
Keywords
Sacral Nerv Stimulation, Neuromodulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInvasive Sacral Neuromodulation
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
DEVICENon-invasive Sacral Neuromodulation
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of defecation consistency | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of proprioception | Baseline and 12 and 24 weeks after start of therapy | Improvement of proprioception is measured as mentioned in the specialized questionnaires. |
| Episodes of urinary incontinence | Baseline and 12 and 24 weeks after start of therapy | The number of episodes per week is evaluated with the criterion for a clinically relevant improvement in cases of reduction by at least 50% of episodes per week. |
| Change of Quality of Life | Baseline and 12 and 24 weeks after start of therapy | The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life. |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Baseline and 12 and 24 weeks after start of therapy | Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors. |
Countries
Germany
Outcome results
None listed