Non-invasive Sacral Nerve Stimulation in Children and Adolescents With Chronic Constipation

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status: Completed

Conditions: Chronic Constipation With Overflow; Hirschprung's Disease; Encopresis With Constipation and Overflow Incontinence; Anorectal Malformations

Treatments: Device: Non-invasive Neuromodulation; Other: Medical and Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04710433

18_20B1

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 2 patient groups

Non-invasive Neuromodulation

Active Comparator group

Description:

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.

Treatment:

Device: Non-invasive Neuromodulation

Medical/behavioral Therapy

Other group

Description:

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).

Treatment:

Other: Medical and Behavioral Therapy