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

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

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

Study Overview

• Status: Completed
• Conditions: Anorectal Malformations; Chronic Constipation With Overflow; Encopresis With Constipation and Overflow Incontinence; Hirschprung's Disease
• Intervention / Treatment: Device: Non-invasive Neuromodulation; Other: Medical and Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Non-invasive Neuromodulation; 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; Sacral nerve stimulation via two adhesive electrodes (single current).
Other: Medical/behavioral Therapy; 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; Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Investigators: Principal Investigator: Manuel Besendörfer, MD, Friedrich-Alexander-Universität Erlangen-Nürnberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Neuromodulation; Sacral Nerve Stimulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Digestive System Diseases; Congenital Abnormalities; Signs and Symptoms, Digestive; Elimination Disorders; Digestive System Abnormalities; Constipation; Anorectal Malformations; Encopresis
• Other Study ID Numbers: 18_20B1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No