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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
External, non-invasive sacral nerve stimulation via two cutaneously adhesive electrodes (single current).
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, Germany
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
Time frame: Baseline and 12 and 24 weeks after start of therapy
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
Time frame: Baseline and 12 and 24 weeks after start of therapy
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
Time frame: Baseline and 12 and 24 weeks after start of therapy
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
Time frame: Baseline and 12 and 24 weeks after start of therapy
Change of proprioception
Improvement of proprioception is measured as mentioned in the specialized questionnaires.
Time frame: Baseline and 12 and 24 weeks after start of therapy
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline and 12 and 24 weeks after start of therapy
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.
Time frame: Baseline and 12 and 24 weeks after start of therapy
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.
Time frame: Baseline and 12 and 24 weeks after start of therapy