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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive Neuromodulation | Active Comparator | 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. |
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| Medical/behavioral Therapy | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Neuromodulation | Device | Sacral nerve stimulation via two adhesive electrodes (single current). |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Diez, MD | Friedrich-Alexander-Universität Erlangen-Nürnberg | Principal Investigator |
| Manuel Besendörfer, MD | 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 |
|---|---|---|---|
| 32373563 | Background | Besendorfer M, Kohl M, Schellerer V, Carbon R, Diez S. A Pilot Study of Non-invasive Sacral Nerve Stimulation in Treatment of Constipation in Childhood and Adolescence. Front Pediatr. 2020 Apr 16;8:169. doi: 10.3389/fped.2020.00169. eCollection 2020. |
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| Medical and Behavioral Therapy | Other | Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted. |
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| ID | Term |
|---|---|
| D000071056 | Anorectal Malformations |
| ID | Term |
|---|---|
| D004065 | Digestive System Abnormalities |
| D004066 | Digestive System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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