Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Change of defecation consistency
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Sacral Neuromodulation
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.
Intervention: Invasive Sacral Neuromodulation (Device)
Non-invasive Sacral Neuromodulation
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: Non-invasive Sacral Neuromodulation (Device)
Outcomes
Primary Outcomes
Change of defecation consistency
Time Frame: Baseline and 12 and 24 weeks after start of therapy
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
Change of episodes of abdominal pain
Time Frame: Baseline and 12 and 24 weeks after start of therapy
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
Time Frame: Baseline and 12 and 24 weeks after start of therapy
Number of episodes of fecal incontinence per week. Definition of success: reduction by at least 50% of episodes per week
Change of defecation frequency
Time Frame: Baseline and 12 and 24 weeks after start of therapy
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
Secondary Outcomes
- Change of proprioception(Baseline and 12 and 24 weeks after start of therapy)
- Change of Quality of Life(Baseline and 12 and 24 weeks after start of therapy)
- Episodes of urinary incontinence(Baseline and 12 and 24 weeks after start of therapy)
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(Baseline and 12 and 24 weeks after start of therapy)
Investigators
Dr. med. Sonja Diez
Principal Investigator, M.D.
Friedrich-Alexander-Universität Erlangen-Nürnberg