Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Constipation With Overflow
- Sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Symptoms: Change in defecation frequency
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Dr. med. Sonja Diez
M.D.
Friedrich-Alexander-Universität Erlangen-Nürnberg
Eligibility Criteria
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
Outcomes
Primary Outcomes
Symptoms: Change in defecation frequency
Time Frame: Baseline and 12 weeks after start of therapy
Defecation frequency is measured by bowel movements per week.
Symptoms: Change in defecation consistency
Time Frame: 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).
Change in Quality of Life
Time Frame: 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.
Symptoms: Change of encopresis/soiling
Time Frame: Baseline and 12 weeks after start of therapy
Episodes of encopresis/soiling are evaluated per day.
Secondary Outcomes
- Symptoms: Change of abdominal pain(Baseline and 12 weeks after start of therapy)