Clinical trial NCT04713085: 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
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Constipation With Overflow
Encopresis With Constipation and Overflow Incontinence
Hirschsprung's Disease
Anorectal Malformations
Sacral Dysgenesis
Keywords: Sacral Nerv Stimulation
Neuromodulation
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of episodes of abdominal pain
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Change of episodes of fecal incontinence
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Change of defecation frequency
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Change of defecation consistency
timeFrame: Baseline and 12 and 24 weeks after start of therapy
Secondary outcomes:
measure: Change of proprioception
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Episodes of urinary incontinence
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Change of Quality of Life
timeFrame: Baseline and 12 and 24 weeks after start of therapy
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Baseline and 12 and 24 weeks after start of therapy
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
state: Bavaria
Study officials:
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Sonja Diez, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Manuel Besendörfer, M.D.
role: PRINCIPAL_INVESTIGATOR
References: