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

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

Detailed Description
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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.

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

Conditions
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Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease, Anorectal Malformations

Intervention / Treatment
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* Device: Non-invasive Neuromodulation
* Other: Medical and Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 2-17 years informed consent chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training) exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism) in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies in cases of anorectal malformation: post-surgical status Exclusion Criteria: metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options toxic megacolon or further emergencies, which must be treated surgically fractures or substantial differences in the sacral anatomy inflammatory bowel disorders rectal prolapse neuronal malignancies under medical and radiation therapy seizures

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-invasive Neuromodulation<br>Application of non-invasive sacral nerve stimulation for 12 weeks, at least 8 hours per day. Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field 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). Medical and behavioral therapy is to be continued as started before intervention. | Device: Non-invasive Neuromodulation<br>* Sacral nerve stimulation via two adhesive electrodes (single current).<br>|
| Other: Medical/behavioral Therapy<br>Patients receive an optimized conventional treatment for 12 weeks, including lifestyle changes, toilet training and weight-adjusted medication. Conventional medical options include oral laxative medication with polyethyleneglycol or rectal medication with saline enemas in possible combination with a stimulant laxative (glycerin or bisacodyl). | Other: Medical and Behavioral Therapy<br>* Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms: Change in defecation frequency | Defecation frequency is measured by bowel movements per week. | Baseline and 12 weeks after start of therapy | 
| Symptoms: Change in defecation consistency | Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). | Baseline and 12 weeks after start of therapy | 
| Symptoms: Change of encopresis/soiling | Episodes of encopresis/soiling are evaluated per day. | Baseline and 12 weeks after start of therapy | 
| Change in 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 weeks after start of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms: Change of abdominal pain | Abdominal pain is recorded in episodes per week and its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain) | Baseline and 12 weeks after start of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sacral Nerve Stimulation, Neuromodulation