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

Anorectal Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710433
• Other study ID #: 18_20B1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2022
• Source: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Non-invasive Neuromodulation
Sacral nerve stimulation via two adhesive electrodes (single current).

Other:
• Medical and Behavioral Therapy
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

Locations

Country	Name	City	State
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Friedrich-Alexander-Universität Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms: Change in defecation frequency	Defecation frequency is measured by bowel movements per week.	Baseline and 12 weeks after start of therapy
Primary	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
Primary	Symptoms: Change of encopresis/soiling	Episodes of encopresis/soiling are evaluated per day.	Baseline and 12 weeks after start of therapy
Primary	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	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