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

Not Applicable

Completed

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

• Registration Number: NCT04710433
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-18
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive Neuromodulation	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.
Medical/behavioral Therapy	Medical and 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).

Primary Outcome Measures

Name	Time	Method
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).
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.
Symptoms: Change of encopresis/soiling	Baseline and 12 weeks after start of therapy	Episodes of encopresis/soiling are evaluated per day.

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery; 🇩🇪 Erlangen, Bavaria, Germany