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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04710433
Other study ID # 18_20B1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2021

Study information

Verified date December 2022
Source Friedrich-Alexander-Universität Erlangen-Nürnberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Non-invasive Neuromodulation
Sacral nerve stimulation via two adhesive electrodes (single current).
Other:
Medical and Behavioral Therapy
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.

Locations

Country Name City State
Germany Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery Erlangen Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Friedrich-Alexander-Universität Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Symptoms: Change in defecation frequency Defecation frequency is measured by bowel movements per week. Baseline and 12 weeks after start of therapy
Primary Symptoms: Change in defecation consistency Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency). Baseline and 12 weeks after start of therapy
Primary Symptoms: Change of encopresis/soiling Episodes of encopresis/soiling are evaluated per day. Baseline and 12 weeks after start of therapy
Primary Change in 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. Baseline and 12 weeks after start of therapy
Secondary Symptoms: Change of abdominal pain Abdominal pain is recorded in episodes per week and its intensity is evaluated via the numeric rating scale (0=no pain, 10=worst imaginable pain) Baseline and 12 weeks after start of therapy
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