RecruitingNot Applicable

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

Israel64 participantsStarted 2024-02-21

Plain-language summary

This study is a randomized, controlled trial designed to evaluate the effects of transcutaneous tibial nerve stimulation (TTNS), TTNS combined with pocket-sized handheld ultrasound (PHUS), and conventional therapy with PHUS on children with functional constipation (FC). Participants will be stratified into three intervention arms (n=20 per group). FC will be defined based on the Rome IV diagnostic criteria, in the absence of organic or anatomical causes. Participants will be between 4 and 14 years old and will have experienced failure of conservative treatment for at least three months prior to enrollment. The primary outcomes include changes in rectal ultrasound parameters and symptom severity scores. Ultrasound assessments will be conducted by trained clinicians using standardized protocols. Monitoring for adverse events will be performed throughout the intervention phase. Safety considerations include predefined exclusion criteria, such as underlying neurological, metabolic, or cardiac conditions.

Who can participate

Age range

4 Years – 14 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 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

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

Severity of constipation using the Wexner Constipation Scoring System (WCSS)

Timeframe: From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessment

Trial details

NCT IDNCT07077044

SponsorHadassah Medical Organization

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-25

Contact for this trial

Mordechai Slae, M.D.

+972585356200 mord@hadassah.org.il

View on ClinicalTrials.gov More Constipation trials