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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacral Neuromodulation | Active Comparator | Sacral neuromodulation is surgically implanted within two surgeries:
Stimulation parameters: Single current, frequency 15Hz, duration 210μs. Stimulation intensity is individually determined beyond the pain threshold (adjustable amplitude between 0-10mA, depending on the intraoperative response). Start point of clinical evaluation is time of implantation of tined lead electrode. Medical and behavioral therapy is to be continued as started before intervention. |
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| Non-invasive Sacral Neuromodulation | Active Comparator | Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field by single current with a 15 Hz frequency for a duration of 210μs. Stimulation intensity is individually determined to achieve an effective and comfortable stimulation beyond the pain threshold (adjustable amplitude between 0-10mA). Start point of clinical evaluation is start of external stimulation. Medical and behavioral therapy is to be continued as started before intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive Sacral Neuromodulation | Device | Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of episodes of abdominal pain | Abdominal pain is recorded in number of episodes per week. Its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain). Definition of success: reduction by at least 50% of episodes per week | Baseline and 12 and 24 weeks after start of therapy |
| Change of episodes of fecal incontinence | Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week | Baseline and 12 and 24 weeks after start of therapy |
| Change of defecation frequency | Defecation frequency is measured by number of bowel movements per week. Definition of success: doubling of episodes per week to at least 3 or more bowel movements per week | Baseline and 12 and 24 weeks after start of therapy |
| Change of defecation consistency | Defecation consistency is measured daily by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). Definition of success: change of at least 2 points within the scale of 1-7 | Baseline and 12 and 24 weeks after start of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change of proprioception | Improvement of proprioception is measured as mentioned in the specialized questionnaires. | Baseline and 12 and 24 weeks after start of therapy |
| Episodes of urinary incontinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Diez, M.D. | Friedrich-Alexander-Universität Erlangen-Nürnberg | Principal Investigator |
| Manuel Besendörfer, M.D. | Friedrich-Alexander-Universität Erlangen-Nürnberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery | Erlangen | Bavaria | 91054 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38515199 | Derived | Besendorfer M, Kirchgatter A, Carbon R, Weiss C, Muller H, Matzel KE, Diez S. Sacral neuromodulation for constipation and fecal incontinence in children and adolescents - study protocol of a prospective, randomized trial on the application of invasive vs. non-invasive technique. Trials. 2024 Mar 22;25(1):210. doi: 10.1186/s13063-024-08052-6. |
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| Non-invasive Sacral Neuromodulation | Device | External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current). |
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The number of episodes per week is evaluated with the criterion for a clinically relevant improvement in cases of reduction by at least 50% of episodes per week.
| Baseline and 12 and 24 weeks after start of therapy |
| Change of Quality of Life | The quality of life is classified via the 'Revised Children's Quality of Life Questionnaire' (KINDLR). It consists of 24 5-point Likert-scale items, covering 6 quality of life dimensions: physical well-being, emotional well-being, self-esteem, family, friends and daily functioning (school or nursery school/kindergarten). Items are partially reverse scored and linearly transformed to a 0 to 100 scale according to the manual. Higher scores indicate a better quality of life. | Baseline and 12 and 24 weeks after start of therapy |
| Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors. | Baseline and 12 and 24 weeks after start of therapy |
| ID | Term |
|---|---|
| D006627 | Hirschsprung Disease |
| D000071056 | Anorectal Malformations |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D008531 | Megacolon |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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