Sacral Neuromodulation in Children and Adolescents

Anorectal Malformations Clinical Trial

Official title: Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anorectal Malformations
• Chronic Constipation With Overflow
• Constipation
• Encopresis
• Encopresis With Constipation and Overflow Incontinence
• Hirschsprung Disease
• Hirschsprung's Disease
• Sacral Dysgenesis

• NCT number: NCT04713085
• Study type: Interventional
• Source: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Contact: Sonja Diez, M.D.
• Phone: 0049 09131 85 32923
• Email: sonja.diez@uk-erlangen.de
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: December 31, 2024