Back to resultsSacral Neuromodulation in Children and Adolescents
Primary Purpose
Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Invasive Sacral Neuromodulation
Non-invasive Sacral Neuromodulation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Constipation With Overflow focused on measuring Sacral Nerv 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 or sacral dyssynergy: post-surgical status
- in cases of invasive approach: symptom release while diagnostic stimulation must be seen in order to conduct further surgeries
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 SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sacral Neuromodulation
Non-invasive Sacral Neuromodulation
Arm Description
Sacral neuromodulation is surgically implanted within two surgeries: Implantation of the final electrode (tined-lead electrode): This electrode is implanted to neuronal fibers of S3/4. Both sides are tested intraoperatively, the side with a sufficient response at lower intensity levels is finally implanted. Stimulation is conducted via an external pulse generator. Implantation of the internal pacemaker system 4 weeks after the electrode's implantation. Stimulation parameters: Single current, frequency 15Hz, duration 210μs. Stimulation intensity is individually determined beyond the pain threshold (adjustable amplitude between 0-10mA, depending on the intraoperative response). Start point of clinical evaluation is time of implantation of tined lead electrode. Medical and behavioral therapy is to be continued as started before intervention.
Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field by single current 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). Start point of clinical evaluation is start of external stimulation. Medical and behavioral therapy is to be continued as started before intervention.
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
Change of proprioception
Improvement of proprioception is measured as mentioned in the specialized questionnaires.
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.
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.
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.
Full Information
NCT ID
NCT04713085
First Posted
January 14, 2021
Last Updated
January 5, 2023
Sponsor
Friedrich-Alexander-Universität Erlangen-Nürnberg
1. Study Identification
Unique Protocol Identification Number
NCT04713085
Brief Title
Sacral Neuromodulation in Children and Adolescents
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
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 neuromodulation for treatment of chronic constipation and fecal incontinence in pediatric patients and to evaluate the differences between the invasive vs. non-invasive approach.
Detailed 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.
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, Hirschsprung's Disease, Anorectal Malformations, Sacral Dysgenesis
Keywords
Sacral Nerv Stimulation, Neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sacral Neuromodulation
Arm Type
Active Comparator
Arm Description
Sacral neuromodulation is surgically implanted within two surgeries:
Implantation of the final electrode (tined-lead electrode): This electrode is implanted to neuronal fibers of S3/4. Both sides are tested intraoperatively, the side with a sufficient response at lower intensity levels is finally implanted. Stimulation is conducted via an external pulse generator.
Implantation of the internal pacemaker system 4 weeks after the electrode's implantation.
Stimulation parameters: Single current, frequency 15Hz, duration 210μs. Stimulation intensity is individually determined beyond the pain threshold (adjustable amplitude between 0-10mA, depending on the intraoperative response).
Start point of clinical evaluation is time of implantation of tined lead electrode.
Medical and behavioral therapy is to be continued as started before intervention.
Arm Title
Non-invasive Sacral Neuromodulation
Arm Type
Active Comparator
Arm Description
Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field by single current 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).
Start point of clinical evaluation is start of external stimulation.
Medical and behavioral therapy is to be continued as started before intervention.
Intervention Type
Device
Intervention Name(s)
Invasive Sacral Neuromodulation
Intervention Description
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
Intervention Type
Device
Intervention Name(s)
Non-invasive Sacral Neuromodulation
Intervention Description
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).
Primary Outcome Measure Information:
Title
Change of episodes of abdominal pain
Description
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
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Title
Change of episodes of fecal incontinence
Description
Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Title
Change of defecation frequency
Description
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
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Title
Change of defecation consistency
Description
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
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Secondary Outcome Measure Information:
Title
Change of proprioception
Description
Improvement of proprioception is measured as mentioned in the specialized questionnaires.
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Title
Episodes of urinary incontinence
Description
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.
Time Frame
Baseline and 12 and 24 weeks after start of therapy
Title
Change of 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 and 24 weeks after start of therapy
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Adverse events are measured as mentioned in the specialized questionnaires: these include cutaneous reactions, urinary incontinence, dysfunction of stimulation or further unknown factors.
Time Frame
Baseline and 12 and 24 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Diez, M.D.
Phone
0049 09131 85 32923
Email
sonja.diez@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Diez, M.D.
Organizational Affiliation
Friedrich-Alexander-Universität Erlangen-Nürnberg
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manuel Besendörfer, M.D.
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonja Diez, M.D.
Phone
0049 09131 85 32923
Email
sonja.diez@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Sacral Neuromodulation in Children and Adolescents
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