Chronic Constipation With OverflowNCT04710433
Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation
A study testing Non-invasive Neuromodulation and Medical and Behavioral Therapy in people with Chronic Constipation With Overflow and Encopresis With Constipation and Overflow Incontinence, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
Trial summary
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease
- What is being tested?
- Non-invasive Neuromodulation and Medical and Behavioral Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, 91054
About this study
Official title: Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
The purpose of this study is to assess the efficacy of additional neuromodulation for treatment of chronic constipation in pediatric patients
Read the 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.
- Conditions
- Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease, Anorectal Malformations
- Being tested
- Non-invasive Neuromodulation, Medical and Behavioral Therapy
- Keywords
- Sacral Nerve Stimulation, Neuromodulation
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive NeuromodulationDevice
Sacral nerve stimulation via two adhesive electrodes (single current).
Medical and Behavioral TherapyOther
Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Neuromodulation | Active comparator | 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. Receives: Device: Non-invasive Neuromodulation |
| Medical/behavioral Therapy | Other | 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). Receives: Other: Medical and Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms: Change in defecation frequency
Defecation frequency is measured by bowel movements per week.
Measured: Baseline and 12 weeks after start of therapy
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).
Measured: Baseline and 12 weeks after start of therapy
Symptoms: Change of encopresis/soiling
Episodes of encopresis/soiling are evaluated per day.
Measured: Baseline and 12 weeks after start of therapy
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.
Measured: Baseline and 12 weeks after start of therapy
Secondary outcomes (1)
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)
Measured: Baseline and 12 weeks after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Constipation With OverflowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Sonja Diez, Friedrich-Alexander-Universität Erlangen-Nürnberg
- Investigators
- Sonja Diez, MD, Principal investigator, Friedrich-Alexander-Universität Erlangen-NürnbergManuel Besendörfer, MD, Principal investigator, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710433
- Sponsor's protocol ID
- 18_20B1
- Status last verified
- Dec 2022
- First submitted
- 8 Jan 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32373563
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation: a Case-control Study on External Neuromodulatory Treatment
- ClinicalTrials.gov ID
- NCT04710433
- Acronym / sponsor ID
- 18_20B1
- Conditions
- Chronic Constipation With Overflow, Encopresis With Constipation and Overflow Incontinence, Hirschprung's Disease, Anorectal Malformations
- Keywords
- Sacral Nerve Stimulation, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Friedrich-Alexander-Universität Erlangen-NürnbergUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Neuromodulation | Active comparator | Device: Non-invasive NeuromodulationApplication 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. |
| Medical/behavioral Therapy | Other | Other: Medical and Behavioral TherapyPatients 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). |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive NeuromodulationSacral nerve stimulation via two adhesive electrodes (single current). | Device | Non-invasive Neuromodulation |
| Medical and Behavioral TherapyBehavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted. | Other | Medical/behavioral Therapy |
Primary outcome
Symptoms: Change in defecation frequency
Time frame: Baseline and 12 weeks after start of therapy
Defecation frequency is measured by bowel movements per week.
Symptoms: Change in defecation consistency
Time frame: Baseline and 12 weeks after start of therapy
Defecation consistency is measured by the Bristol Stool Scale, which classifies stool consistency from 1 (hard consistency) to 7 (fluid consistency).
Symptoms: Change of encopresis/soiling
Time frame: Baseline and 12 weeks after start of therapy
Episodes of encopresis/soiling are evaluated per day.
Change in Quality of Life
Time frame: Baseline and 12 weeks after start of therapy
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.
1 secondary outcome
Symptoms: Change of abdominal pain
Time frame: Baseline and 12 weeks after start of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Background: PubMed 32373563Besendorfer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonja Diez, MD principal investigator
Friedrich-Alexander-Universität Erlangen-Nürnberg
Manuel Besendörfer, MD principal investigator
Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive Neuromodulation and Medical and Behavioral Therapy in people with Chronic Constipation With Overflow and Encopresis With Constipation and Overflow Incontinence, run by Friedrich-Alexander-Universität Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms: Change in defecation frequency (time frame: Baseline and 12 weeks after start of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04710433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.