Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation (NCT04710433) | Clinical Trial Compass
CompletedNot Applicable
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
Germany59 participantsStarted 2018-01-01
Plain-language summary
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients
Who can participate
Age range
2 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Symptoms: Change in defecation frequency
Timeframe: Baseline and 12 weeks after start of therapy
2
Symptoms: Change in defecation consistency
Timeframe: Baseline and 12 weeks after start of therapy
3
Symptoms: Change of encopresis/soiling
Timeframe: Baseline and 12 weeks after start of therapy
4
Change in Quality of Life
Timeframe: Baseline and 12 weeks after start of therapy