Sacral Neuromodulation in Children and Adolescents
Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease
About this trial
This is an interventional treatment trial for Chronic Constipation With Overflow focused on measuring Sacral Nerv Stimulation, Neuromodulation
Eligibility Criteria
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
- refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training)
- exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism)
- in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies
- in cases of anorectal malformation or sacral dyssynergy: post-surgical status
- in cases of invasive approach: symptom release while diagnostic stimulation must be seen in order to conduct further surgeries
Exclusion Criteria:
- metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options
- toxic megacolon or further emergencies, which must be treated surgically
- fractures or substantial differences in the sacral anatomy
- inflammatory bowel disorders
- rectal prolapse
- neuronal malignancies under medical and radiation therapy
- seizures
Sites / Locations
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Sacral Neuromodulation
Non-invasive Sacral Neuromodulation
Sacral neuromodulation is surgically implanted within two surgeries: Implantation of the final electrode (tined-lead electrode): This electrode is implanted to neuronal fibers of S3/4. Both sides are tested intraoperatively, the side with a sufficient response at lower intensity levels is finally implanted. Stimulation is conducted via an external pulse generator. Implantation of the internal pacemaker system 4 weeks after the electrode's implantation. Stimulation parameters: Single current, frequency 15Hz, duration 210μs. Stimulation intensity is individually determined beyond the pain threshold (adjustable amplitude between 0-10mA, depending on the intraoperative response). Start point of clinical evaluation is time of implantation of tined lead electrode. Medical and behavioral therapy is to be continued as started before intervention.
Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field by single current with a 15 Hz frequency for a duration of 210μs. Stimulation intensity is individually determined to achieve an effective and comfortable stimulation beyond the pain threshold (adjustable amplitude between 0-10mA). Start point of clinical evaluation is start of external stimulation. Medical and behavioral therapy is to be continued as started before intervention.