Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation

  • STATUS
    Recruiting
  • End date
    Jun 2, 2022
  • participants needed
    30
  • sponsor
    Friedrich-Alexander-Universität Erlangen-Nürnberg
Updated on 2 February 2021

Summary

The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation in pediatric patients and evaluate the differences between the invasive and non-invasive approach.

Description

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 randomized to one of the two predefined subgroups: either invasive sacral nerve stimulation or non-invasive sacral nerve stimulation. Clinical symptoms and outcome variables are compared with beginning of non-invasive sacral nerve stimulation or starting from implantation of tined lead. 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.

Details
Condition Hirschsprung's Disease, Chronic Constipation With Overflow, Anorectal Malformations, Encopresis With Constipation and Overflow Incontinence, Sacral Dysgenesis
Treatment sacral nerve stimulation, Non-invasive Sacral Nerve Stimulation
Clinical Study IdentifierNCT04713085
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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