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

NCT04710433 | Completed

• 1 other identifier: 18_20B1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Sacral Nerve Stimulation; Neuromodulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Symptoms: Change of abdominal pain

  Baseline and 12 weeks after start of therapy

Study Arms (2)

Non-invasive Neuromodulation

ACTIVE COMPARATOR

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

Medical/behavioral Therapy

OTHER

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

Interventions

Non-invasive Neuromodulation DEVICE

Sacral nerve stimulation via two adhesive electrodes (single current).

Non-invasive Neuromodulation

Medical and Behavioral Therapy OTHER

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

Medical/behavioral Therapy

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies
• in cases of anorectal malformation: post-surgical status

You may not qualify if:

• 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

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

Location

Related 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.

  PMID: 32373563 BACKGROUND

MeSH Terms

Conditions

Anorectal Malformations

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Sonja Diez, MD

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

• Manuel Besendörfer, MD

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 14, 2021
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)