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

NCT07077044 | Recruiting DMC FDA Device

• 2 other identifiers: Protocol HMO-0446-23Hadassah Medical Center trial
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Constipation; Constipation - Functional

Keywords

children with functional constipation

Outcome Measures

Primary Outcomes (1)

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

  The Wexner Constipation Scoring System (WCSS) will be used to quantify the severity of constipation and evaluate treatment effectiveness. The scale includes 8 items assessing: (1) frequency of defecation, (2) painful defecation, (3) incomplete evacuation, (4) abdominal pain, (5) time per attempt, (6) type of assistance, (7) number of unsuccessful attempts per 24 hours, and (8) duration of symptoms. Items are rated 0-4, except for assistance (0-2), with total scores ranging from 0 to 30 (higher scores = more severe constipation). Time Frame: Baseline and 4 weeks after intervention start Unit of Measure: Score on a 0-30 scale Secondary Outcome Measures Each outcome must be listed separately, with clear title, description, time frame, and unit. 1\. Stool consistency using the Bristol Stool Form Scale (BSFS) Description: The BSFS classifies stool on a 7-point scale (1 = separate hard lumps; 7 = watery), used to monitor stool consistency. Time Frame: Daily entries over 4 weeks Unit of

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

Secondary Outcomes (1)

• stool consistency using the Bristol Stool Form Scale (BSFS)77,78 (Appendix 5). The BSFS classifies and categorizes stool consistency on a 7-point scale according to cohesion and surface cracking

  24 hours

Study Arms (3)

TTNS treatment with no PHUS assessments

EXPERIMENTAL

TTNS treatment with no PHUS assessments

Device: The transcutaneous posterior tibial nerve stimulation device

TTNS treatment combined with PHUS assessments

EXPERIMENTAL

TTNS treatment combined with PHUS assessments

Device: The transcutaneous posterior tibial nerve stimulation device; Other: PSUS

Conventional treatment

ACTIVE COMPARATOR

conventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician.

Other: PSUS

Interventions

The transcutaneous posterior tibial nerve stimulation device DEVICE

In addition to their conventional treatment, subjects in both TTNS groups will complete eight weeks of home TTNS treatment (3 sessions per week), and each session will last for 20 minutes. Stimulation will be provided by a portable device (Chattanooga®, ContinuumTM, Hixson, TN, USA). The device will be pre-programmed to apply a bi-phasic squared wave with a pulse width of 200μsec, and a pulse frequency of 20 Hz. These are default settings for TTNS that have been used in previous studies for urinary and fecal incontinence59,62,67. Two self-adhesive electrodes (5 x 5 cm) will be placed over the ankle area, one approximately 3 to 4 cm above the medial tibial malleolus and a second electrode just below the medial malleolus of the same leg.

TTNS treatment combined with PHUS assessments; TTNS treatment with no PHUS assessments

PSUS OTHER

Handheld US

Conventional treatment; TTNS treatment combined with PHUS assessments

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hebrew University Hospital

Jerusalem, 91120, Israel

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mordechai Slae, M.D.

CONTACT

+972585356200; mord@hadassah.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Arm 1 - TTNS Treatment Only Participants will receive transcutaneous tibial nerve stimulation (TTNS) according to a predefined home-based protocol. Arm 2 - TTNS + PHUS Monitoring Participants will receive TTNS as in Arm 1, in combination with periodic monitoring using portable handheld ultrasound (PHUS) to assess rectal parameters. Arm 3 - Conventional Treatment + PHUS Monitoring Participants will continue standard pharmacological and behavioral therapy (toilet training and laxatives), monitored by PHUS at regular intervals.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will include a convenience sample of 60 children aged 4-14 years who were diagnosed with FC by a physician according to the diagnostic criteria of Rome IV and who had already received treatment for constipation for at least one month, including toilet training and laxative therapy. These will be chosen from the patients visiting the pediatric gastroenterology clinic at Hadassah Medical Center. An a priori power analysis (G-Power software, Version 3.1) with the following parameters: 1-β = 0.80, effect size = 0.6, and α = 0.05 was calculated to determine the sample size for comparing the effects of TTNS, TTNS combined with PHUS, and conventional therapy with PHUS. This indicated that a total sample of 48 participants would be needed to detect the main effects. To address the problem of inflated effect size estimates and possible dropout of participants, we will recruit a sample of 60 subjects, 20 subjects for each group. A participant is entitled to withdraw from the study at a

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: July 22, 2025
• Study Start: February 21, 2024
• Primary Completion: February 25, 2026
• Study Completion: February 25, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)