Sacral Neuromodulation in Children and Adolescents

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status: Completed

Conditions: Chronic Constipation With Overflow; Hirschsprung's Disease; Sacral Dysgenesis; Encopresis With Constipation and Overflow Incontinence; Anorectal Malformations

Treatments: Device: Invasive Sacral Neuromodulation; Device: Non-invasive Sacral Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04713085

18_20B2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sacral Neuromodulation

Active Comparator group

Description:

Sacral neuromodulation is surgically implanted within two surgeries: 1. 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. 2. 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.

Treatment:

Device: Invasive Sacral Neuromodulation

Non-invasive Sacral Neuromodulation

Active Comparator group

Description:

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.

Treatment:

Device: Non-invasive Sacral Neuromodulation