Neuromodulation for treating chronic constipation in children and adolescents
Sacral Neuromodulation for Constipation and Fecal Incontinence in Children and Adolescents - Randomized Controlled Trial on the Application of Invasive vs. Non-invasive Technique
NA · Friedrich-Alexander-Universität Erlangen-Nürnberg · NCT04713085
This study tests if a new treatment using nerve stimulation can help children and teens aged 2 to 17 with chronic constipation and bowel issues feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT04713085 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of sacral neuromodulation in treating chronic constipation and fecal incontinence in pediatric patients. Participants aged 2 to 17 years are randomized into two groups: one receiving invasive sacral neuromodulation and the other receiving a non-invasive approach. The study monitors clinical symptoms and outcomes over a six-month period, with assessments at regular intervals using questionnaires and bowel movement diaries. Quality of life is also measured at baseline and after 12 and 24 weeks of treatment.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 2-17 years with chronic constipation or fecal incontinence that has not responded to conventional treatments.
Not a fit: Patients with metabolic, inflammatory, or hormonal causes of chronic constipation, or those with acute surgical emergencies, will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel function and quality of life for children suffering from chronic constipation and fecal incontinence.
How similar studies have performed: While neuromodulation has been explored in adult populations, this specific application in pediatric patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Erlangen, Bavaria
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery — Erlangen, Bavaria, Germany (RECRUITING)
Study contacts
- Principal investigator: Sonja Diez, M.D. — Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study coordinator: Sonja Diez, M.D.
- Email: sonja.diez@uk-erlangen.de
- Phone: 0049 09131 85 32923
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschsprung's Disease, Anorectal Malformations, Sacral Dysgenesis, Sacral Nerv Stimulation, Neuromodulation