Clinical trial NCT04710433: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Constipation With Overflow
Encopresis With Constipation and Overflow Incontinence
Hirschprung's Disease
Anorectal Malformations
Keywords: Sacral Nerve Stimulation
Neuromodulation
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 59
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Symptoms: Change in defecation frequency
timeFrame: Baseline and 12 weeks after start of therapy
measure: Symptoms: Change in defecation consistency
timeFrame: Baseline and 12 weeks after start of therapy
measure: Symptoms: Change of encopresis/soiling
timeFrame: Baseline and 12 weeks after start of therapy
measure: Change in Quality of Life
timeFrame: Baseline and 12 weeks after start of therapy
Secondary outcomes:
measure: Symptoms: Change of abdominal pain
timeFrame: Baseline and 12 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, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander-Universität Erlangen-Nürnberg
name: Manuel Besendörfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.