Back to resultsNon-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Primary Purpose
Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Non-invasive Neuromodulation
Medical and Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation With Overflow focused on measuring Sacral Nerve Stimulation, Neuromodulation
Eligibility Criteria
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
Sites / Locations
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Non-invasive Neuromodulation
Medical/behavioral Therapy
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Symptoms: Change in defecation frequency
Defecation frequency is measured by bowel movements per week.
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).
Symptoms: Change of encopresis/soiling
Episodes of encopresis/soiling are evaluated per day.
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT04710433
First Posted
January 8, 2021
Last Updated
December 18, 2022
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT04710433
Brief Title
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Official Title
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease, Anorectal Malformations
Keywords
Sacral Nerve Stimulation, Neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-invasive Neuromodulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Medical/behavioral Therapy
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Non-invasive Neuromodulation
Intervention Description
Sacral nerve stimulation via two adhesive electrodes (single current).
Intervention Type
Other
Intervention Name(s)
Medical and Behavioral Therapy
Intervention Description
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
Primary Outcome Measure Information:
Title
Symptoms: Change in defecation frequency
Description
Defecation frequency is measured by bowel movements per week.
Time Frame
Baseline and 12 weeks after start of therapy
Title
Symptoms: Change in defecation consistency
Description
Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency).
Time Frame
Baseline and 12 weeks after start of therapy
Title
Symptoms: Change of encopresis/soiling
Description
Episodes of encopresis/soiling are evaluated per day.
Time Frame
Baseline and 12 weeks after start of therapy
Title
Change in Quality of Life
Description
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.
Time Frame
Baseline and 12 weeks after start of therapy
Secondary Outcome Measure Information:
Title
Symptoms: Change of abdominal pain
Description
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)
Time Frame
Baseline and 12 weeks after start of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Diez, MD
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Besendörfer, MD
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32373563
Citation
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.
Results Reference
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Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
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