Ignite Creation Date:
2024-05-06 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04710433
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-01-08
Brief Title:
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Sponsor:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Organization:
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study Overview
Official Title:
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation a Case-control Study on External Neuromodulatory Treatment
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 4812 and via specialized questionnaires and bowel movement diaries Quality of life is evaluated at baseline and after 12 weeks of treatment
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 4812 and via specialized questionnaires and bowel movement diaries Quality of life is evaluated at baseline and after 12 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None