Status:
COMPLETED
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Lead Sponsor:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Conditions:
Chronic Constipation With Overflow
Encopresis With Constipation and Overflow Incontinence
Eligibility:
All Genders
2-17 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients
Detailed 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 informe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04710433
Start Date
January 1 2018
End Date
December 31 2021
Last Update
December 20 2022
Active Locations (1)
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1
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, Germany, 91054