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

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    50
  • sponsor
    Friedrich-Alexander-Universität Erlangen-Nürnberg
Updated on 17 September 2021
Investigator
Sonja Diez, M.D.
Primary Contact
Friedrich-Alexander-Universit t Erlangen-N rnberg, Pediatric Surgery (8.7 mi away) Contact

Summary

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

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 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.

Details
Condition Chronic Constipation With Overflow, Anorectal Malformations, Hirschprung's Disease, Encopresis With Constipation and Overflow Incontinence
Treatment Non-invasive Neuromodulation, Medical and Behavioral Therapy
Clinical Study IdentifierNCT04710433
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg
Last Modified on17 September 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: 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
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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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