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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04710433
Study type Interventional
Source Friedrich-Alexander-Universität Erlangen-Nürnberg
Contact
Status Completed
Phase N/A
Start date January 1, 2018
Completion date December 31, 2021

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