Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation

Friedrich-Alexander-Universität Erlangen-Nürnberg59 enrolled

Overview

The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients

Patients are selected according to the eligibility requirements. After being informed about the study and potential risks of neuromodulation, all included patients and next of kin give written informed consent to the study. At baseline, patients are classified to one of the two predefined subgroups: either medical and behavioral therapy is extended and optimized or neuromodulatory treatment is started with non-invasive sacral nerve stimulation via single current and two external adhesive electrodes. Within 12 weeks, treatment success is evaluated in routine clinical check-ups (week 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 weeks of treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Constipation With Overflow Encopresis With Constipation and Overflow Incontinence Hirschprung's Disease Anorectal Malformations

Interventions

Non-invasive NeuromodulationDEVICE

Sacral nerve stimulation via two adhesive electrodes (single current).

Medical and Behavioral TherapyOTHER

Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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: post-surgical status 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

Locations (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, Germany