ConstipationconstipationNCT07077044
The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
A study testing The transcutaneous posterior tibial nerve stimulation device and PSUS in people with Constipation and Constipation - Functional, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Constipation - Functional
- What is being tested?
- The transcutaneous posterior tibial nerve stimulation device and PSUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Feb 2024to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.
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.
Read the detailed description
Eligibility Criteria
Inclusion Criteria:
Children aged 4 to 14 years.
Diagnosis of functional constipation (FC) established prior to study enrollment. FC is defined according to the Rome IV diagnostic criteria, in the absence of identifiable organic or anatomical causes (e.g., no endocrine, metabolic, anatomical, or neuromuscular dysfunction). No additional diagnostic testing is required for inclusion.
Ability to complete daily diaries and TTNS sessions, either independently or with caregiver support.
Documented failure of conservative medical treatment following at least three months of therapy.
Exclusion Criteria:
Malformations of the digestive system or rectal anatomical anomalies (e.g., large intestinal atresia or stenosis, Hirschsprung's disease, congenital anorectal malformations).
Neurological or psychiatric conditions (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa).
Major cognitive impairments.
Metabolic disorders (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria).
Endocrine disorders (e.g., hypothyroidism).
Cardiovascular conditions such as heart disease or arrhythmias, or presence of ventriculoperitoneal shunts or cardiac pacemakers, due to potential electrical interference.
History of thoracic or abdominal surgery.
Presence of dermatological lesions in the area of electrode application.
Presence of active electronic implants.
- Conditions
- Constipation, Constipation - Functional
- Being tested
- The transcutaneous posterior tibial nerve stimulation device, PSUS
- Keywords
- children with functional constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The transcutaneous posterior tibial nerve stimulation deviceDevice
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.
PSUSOther
Handheld US
| Study group | Role | What they receive |
|---|---|---|
| TTNS treatment with no PHUS assessments | Experimental | TTNS treatment with no PHUS assessments Receives: Device: The transcutaneous posterior tibial nerve stimulation device |
| TTNS treatment combined with PHUS assessments | Experimental | TTNS treatment combined with PHUS assessments Receives: 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. Receives: Other: PSUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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
Measured: 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
: 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, as follows: 1, separate hard lumps (like nuts); 2, sausage-shaped but lumpy; 3, like a sausage or snake but with cracks on its surface; 4, like a smooth and soft sausage or snake; 5, soft blobs with a clearcut edge; 6, fluffy pieces with ragged edges and mushy; and 7, watery without solid pieces (1 to 3 indicate constipation; 4-5 is "ideal" stools; 6-7 show paradoxical diarrhea); Numbers of episodes per day will be recorded for 2) defecation; 3) soiling; 4) abdominal pain; 5) presence of bloody stool; A Hebrew version of the visual analog scale (VAS) (Appendix 6) will be used to document a) sensation or urge to defecate79; b) straining and pain during each documented defecation.79 In addition, data on the use of medications for defecation and enemas and/or special diets, as well
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start21 Feb 2024
- Primary completion1 Sep 2026
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07077044
- Sponsor's protocol ID
- Protocol HMO-0446-23
- Other IDs
- Hadassah Medical Center trial
- Acronym
- constipation
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: : There is currently no plan to share individual participant data (IPD) from this study. The data include sensitive pediatric health information. While de-identification procedures are in place, additional ethical and logistical considerations limit the ability to make IPD publicly available at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.
- ClinicalTrials.gov ID
- NCT07077044
- Acronym / sponsor ID
- constipation / Protocol HMO-0446-23
- Conditions
- Constipation, Constipation - Functional
- Keywords
- children with functional constipation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 22 Jul 2025 (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.
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.
Detailed description
Eligibility Criteria
Inclusion Criteria:
Children aged 4 to 14 years.
Diagnosis of functional constipation (FC) established prior to study enrollment. FC is defined according to the Rome IV diagnostic criteria, in the absence of identifiable organic or anatomical causes (e.g., no endocrine, metabolic, anatomical, or neuromuscular dysfunction). No additional diagnostic testing is required for inclusion.
Ability to complete daily diaries and TTNS sessions, either independently or with caregiver support.
Documented failure of conservative medical treatment following at least three months of therapy.
Exclusion Criteria:
Malformations of the digestive system or rectal anatomical anomalies (e.g., large intestinal atresia or stenosis, Hirschsprung's disease, congenital anorectal malformations).
Neurological or psychiatric conditions (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa).
Major cognitive impairments.
Metabolic disorders (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria).
Endocrine disorders (e.g., hypothyroidism).
Cardiovascular conditions such as heart disease or arrhythmias, or presence of ventriculoperitoneal shunts or cardiac pacemakers, due to potential electrical interference.
History of thoracic or abdominal surgery.
Presence of dermatological lesions in the area of electrode application.
Presence of active electronic implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| TTNS treatment with no PHUS assessments | Experimental | Device: The transcutaneous posterior tibial nerve stimulation deviceTTNS treatment with no PHUS assessments |
| TTNS treatment combined with PHUS assessments | Experimental | Device: The transcutaneous posterior tibial nerve stimulation device, Other: PSUSTTNS treatment combined with PHUS assessments |
| Conventional treatment | Active comparator | Other: PSUSconventional treatment recommendations (medications, diets, and behaviors) previously prescribed by their treating physician. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| The transcutaneous posterior tibial nerve stimulation deviceIn 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. | Device | TTNS treatment combined with PHUS assessments, TTNS treatment with no PHUS assessments |
| PSUSHandheld US | Other | Conventional treatment, TTNS treatment combined with PHUS assessments |
Primary outcome
Severity of constipation using the Wexner Constipation Scoring System (WCSS)
Time frame: From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessment
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
1 secondary outcome
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
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. : There is currently no plan to share individual participant data (IPD) from this study. The data include sensitive pediatric health information. While de-identification procedures are in place, additional ethical and logistical considerations limit the ability to make IPD publicly available at this stage.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The transcutaneous posterior tibial nerve stimulation device and PSUS in people with Constipation and Constipation - Functional, run by Hadassah Medical Organization at 1 site in Israel.
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 14 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
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?
Severity of constipation using the Wexner Constipation Scoring System (WCSS) (time frame: From enrollment to the end of treatment 8 weeks. Then 4 month after this end- will be US final reassessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.