Anorectal Malformations, Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease
Conditions
Keywords
Sacral Nerve Stimulation, Neuromodulation
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 4/8/12) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 weeks of treatment.
Interventions
Sacral nerve stimulation via two adhesive electrodes (single current).
OTHERMedical and Behavioral Therapy
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
Sponsors
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms: Change in defecation frequency | Baseline and 12 weeks after start of therapy | Defecation frequency is measured by bowel movements per week. |
| Symptoms: Change in defecation consistency | Baseline and 12 weeks after start of therapy | Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). |
| Symptoms: Change of encopresis/soiling | Baseline and 12 weeks after start of therapy | Episodes of encopresis/soiling are evaluated per day. |
| Change in Quality of Life | Baseline and 12 weeks after start of therapy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms: Change of abdominal pain | Baseline and 12 weeks after start of therapy | 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) |
Countries
Germany
Outcome results
None listed