Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
NCT ID: NCT04710433
Last Updated: 2022-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2018-01-01
2021-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-invasive Neuromodulation
Application of non-invasive sacral nerve stimulation for 12 weeks, at least 8 hours per day.
Two adhesive electrodes are placed paravertebrally between L1 and L4 and periumbilically, generating an electrical field 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).
Medical and behavioral therapy is to be continued as started before intervention.
Non-invasive Neuromodulation
Sacral nerve stimulation via two adhesive electrodes (single current).
Medical/behavioral Therapy
Patients receive an optimized conventional treatment for 12 weeks, including lifestyle changes, toilet training and weight-adjusted medication. Conventional medical options include oral laxative medication with polyethyleneglycol or rectal medication with saline enemas in possible combination with a stimulant laxative (glycerin or bisacodyl).
Medical and Behavioral Therapy
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
Interventions
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Non-invasive Neuromodulation
Sacral nerve stimulation via two adhesive electrodes (single current).
Medical and Behavioral Therapy
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
17 Years
ALL
No
Sponsors
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Friedrich-Alexander-Universität Erlangen-Nürnberg
OTHER
Responsible Party
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Dr. med. Sonja Diez
M.D.
Principal Investigators
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Sonja Diez, MD
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Alexander-Universität Erlangen-Nürnberg
Manuel Besendörfer, MD
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Alexander-Universität Erlangen-Nürnberg
Locations
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Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, Germany
Countries
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References
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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.
Other Identifiers
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18_20B1
Identifier Type: -
Identifier Source: org_study_id