Clinical Trials Directory

Trials / Completed

CompletedNCT04710433

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

Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg · Academic / Other
Sex
All
Age
2 Years – 17 Years
Healthy volunteers
Not accepted

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 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.

Conditions

Interventions

TypeNameDescription
DEVICENon-invasive NeuromodulationSacral nerve stimulation via two adhesive electrodes (single current).
OTHERMedical and Behavioral TherapyBehavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

Timeline

Start date
2018-01-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2021-01-14
Last updated
2022-12-20

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT04710433. Inclusion in this directory is not an endorsement.