Trials / Completed
CompletedNCT04713085
Sacral Neuromodulation in Children and Adolescents
Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (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 neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.
Detailed 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.
Conditions
- Chronic Constipation With Overflow
- Encopresis With Constipation and Overflow Incontinence
- Hirschsprung's Disease
- Anorectal Malformations
- Sacral Dysgenesis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Invasive Sacral Neuromodulation | Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4) |
| DEVICE | Non-invasive Sacral Neuromodulation | External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current). |
Timeline
- Start date
- 2019-01-01
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
- First posted
- 2021-01-19
- Last updated
- 2025-09-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT04713085. Inclusion in this directory is not an endorsement.