The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.

Launched by HADASSAH MEDICAL ORGANIZATION · Jul 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying different treatments for children who have functional constipation—a type of constipation not caused by any physical or medical problems. The study compares three approaches: a gentle nerve stimulation treatment called TTNS, TTNS combined with a small handheld ultrasound device (PHUS), and the usual therapy combined with this ultrasound device. The goal is to see which method helps improve bowel symptoms and changes seen on ultrasound images of the rectum.

Children between 4 and 14 years old who have had constipation for at least three months and haven’t improved with usual treatments like diet changes or laxatives may be eligible. Participants will be divided into three groups, each receiving one of the treatments. During the study, trained healthcare providers will use ultrasound to monitor changes, and families will keep daily records of symptoms. Safety checks will be done throughout, and some children won’t be able to join if they have certain health conditions like heart problems, nerve disorders, or implanted electronic devices. This study is currently recruiting children to better understand how these treatments might help manage functional constipation.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria Children aged 4 to 14 years
• • Clinical diagnosis of functional constipation (FC), with no identifiable organic or anatomical cause (e.g., endocrine, metabolic, anatomical, or neuromuscular dysfunction)
• • FC diagnosis established according to Rome IV criteria
• • No additional tests required to confirm eligibility
• • Ability to complete daily diaries and TTNS sessions (by participant or caregiver)
• • Failure of conservative medical treatment (including toilet training and laxatives) after at least three months
• • Exclusion Criteria Malformations of the digestive system and rectal anatomical anomalies (e.g., large intestinal atresia/stenosis, Hirschsprung's disease, congenital anorectal anomalies)
• • Neurological or psychiatric disorders (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa)
• • Major cognitive impairment
• • Metabolic conditions (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria)
• • Endocrine disorders (e.g., hypothyroidism)
• • Cardiac conditions (e.g., heart disease, arrhythmias, presence of pacemaker or ventriculoperitoneal shunt) due to possible interference with electrical stimulation
• • History of thoracic or abdominal surgery
• • Presence of skin lesions in the area of electrode application
• • Presence of active electronic implants