Sacral Neuromodulation in Children and Adolescents

Anorectal Malformations Clinical Trial

Official title:

Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04713085
• Other study ID #: 18_20B2
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Contact: Sonja Diez, M.D.
• Phone: 0049 09131 85 32923
• Email: sonja.diez[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.

Description:

Patients are selected according to the eligibility requirements. After obtaining informed consent off-label use and potential risks of sacral neuromodulation, all included patients and next of kin give written informed consent to the study.

At baseline, patients are randomized to one of the two predefined subgroups: either invasive sacral neuromodulation or non-invasive sacral neuromodulation. Clinical symptoms and outcome variables are compared regarding the beginning of non-invasive sacral neuromodulation or the implantation of the tined lead electrode. Patients are closely monitored within 6 months. Treatment success is evaluated in routine clinical check-ups (week 4/8/12 and 24) and via specialized questionnaires and bowel movement diaries. Quality of life is evaluated at baseline and after 12 and 24 weeks of treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• 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 despite underlying diseases such as slow-transit constipation, rectal evacuation disorders or Hirschsprung's disease.

• refractory to conventional treatment in an appropriate weight-adapted application (training for bowel movements, lifestyle changes, pelvic floor training, pharmacological options)

• in cases of Hirschsprung's disease: diagnosis confirmed histologically by rectal biopsies and in case of resection of an aganglionic segement: period between surgery and SNM at least 1 year

• in cases of anorectal malformation or mechanical obstruction: post-surgical status:

period between surgery and SNM at least 1 year

Exclusion Criteria:

• metabolic, inflammatory, and hormonal causes for chronic constipation

• toxic megacolon or further emergencies, which must be treated surgically

• sacral 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
• Hirschsprung Disease
• Hirschsprung's Disease
• Sacral Dysgenesis

Intervention

Device:
• Invasive Sacral Neuromodulation
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
• Non-invasive Sacral Neuromodulation
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of episodes of abdominal pain	Abdominal pain is recorded in number of episodes per week. Its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain). Definition of success: reduction by at least 50% of episodes per week	Baseline and 12 and 24 weeks after start of therapy
Primary	Change of episodes of fecal incontinence	Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week	Baseline and 12 and 24 weeks after start of therapy
Primary	Change of defecation frequency	Defecation frequency is measured by number of bowel movements per week. Definition of success: doubling of episodes per week to at least 3 or more bowel movements per week	Baseline and 12 and 24 weeks after start of therapy
Primary	Change of defecation consistency	Defecation consistency is measured daily by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). Definition of success: change of at least 2 points within the scale of 1-7	Baseline and 12 and 24 weeks after start of therapy
Secondary	Change of proprioception	Improvement of proprioception is measured as mentioned in the specialized questionnaires.	Baseline and 12 and 24 weeks after start of therapy
Secondary	Episodes of urinary incontinence	The number of episodes per week is evaluated with the criterion for a clinically relevant improvement in cases of reduction by at least 50% of episodes per week.	Baseline and 12 and 24 weeks after start of therapy
Secondary	Change of 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 and 24 weeks after start of therapy
Secondary	Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors.	Baseline and 12 and 24 weeks after start of therapy