ConstipationNCT05059756
PTNS and PFR in the Treatment of Childhood Constipation
A study testing PTNS in people with Constipation and Childhood ALL, run by Shengjing Hospital at 1 site in China.
Trial summary
Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of children's constipation is full of challenges, and treatment methods are diverse. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Constipation, Childhood ALL, Pelvic Floor Disorders
- What is being tested?
- PTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2019to 8 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 4-14 years old;
- Meeting the Roman IV criteria for childhood constipation;
- After one course of PEG and one course of Chinese medicine treatment, it was ineffective;
- Pelvic floor surface electromyography (EMG) and 3-D manometry of the anus revealed pelvic floor dysfunction
- Exclusion Criteria:meet one of the following criteria to be excluded:
- The onset of intestinal stenosis due to organic diseases (such as anal fissure, inflammation, intestinal polyps, intestinal adhesion, Crohn's disease, intestinal tuberculosis, tumor, etc.);
Show all 13Show fewer
- constipation due to congenital diseases (such as congenital megacolon, sigmoid colon, etc.);
- Caused by metabolic endocrine diseases, neurological diseases and mental diseases;
- Those caused by systemic organic diseases;
- Patients diagnosed as outlet obstructive constipation and mixed functional constipation;
- Children with severe systemic diseases;
- Children with positive occult blood in stool routine examination;
- Children who refused to participate in PTNS combined with PFR.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation
Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of children's constipation is full of challenges, and treatment methods are diverse.
Studies have shown that pelvic floor dysfunction is a common cause of intractable constipation in children. Zhang et al. have confirmed the role of pelvic floor dysfunction in pediatric constipation. At present, the main methods for pelvic floor dysfunction include surface electromyography and anorectal manometry which have been widely used in children with constipation and they are helpful for the diagnosis of pelvic floor dysfunction in children with constipation.
Sacral nerve electrical stimulation combined with pelvic floor rehabilitation is an effective method for the treatment of pelvic floor dysfunction. It offers a novel approach for the treatment of intractable constipation with pelvic floor dysfunction . At present, there are many methods for sacral nerve regulation. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as sacral nerve regulation, and has the advantages of small trauma, safety, and convenience. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. Therefore, in this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.
Read the detailed description
Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of childhood constipation is full of challenges, and treatment methods are diverse. For example, diet control, behavioral intervention and oral Laxative, bowl management, surgical treatment and other methods can be used for the treatment of childhood constipation. Therefore, a number of guidelines for constipation in children have been developed to regulate the treatment of constipation in children. Fiber intake and polyethylene glycol are recommended as the first line choice for constipation in North American and European guidelines. However, through clinical tests, the effectiveness of PEG3350 laxative and fiber does not last, or it does not work after long-term use. Therefore, additional treatment interventions are necessary. Zhang et al. applied traditional Chinese medicine to treat childhood constipation, which greatly improved the efficacy and reduced the recurrence rate, but there were still nearly 30% intractable constipation left, and other treatment methods were needed.
Studies have shown that secondary pelvic floor dysfunction is a common cause of intractable constipation in children. The incidence of pelvic floor dysfunction is high in children with constipation, and it has a great impact on the symptoms of constipation. Zhang et al. applied defecography to examine 76 children with constipation and found that there existed different pelvic floor dysfunction such as rectocele, puborectal muscle spasm, pelvic floor spasm syndrome and sigmoid hernia in the defecation of children with constipation. In addition, the pelvic floor dysfunction in children was mainly spastic, while in adults it was mainly flaccid. Although these results confirm the role of pelvic floor dysfunction in pediatric constipation, the pelvic floor function was not evaluated. At present, the main methods for pelvic floor function include surface electromyography and anorectal manometry.
Based on the above theory, Claire Zar-Kessler et al. completed a retrospective study of 69 children in which researchers compared the clinical outcome of patients who underwent pelvic floor physical therapy (n = 49) to control patients (n = 20) whom received only medical treatment (laxatives/stool softeners), determined by anorectal manometry and balloon expulsion testing and come to the conclusion that the new field of pelvic floor physical therapy is a safe and effective intervention for children with dyssynergic defecation causing or contributing to chronic constipation. In recent years, more and more studies have confirmed that childhood constipation is resulted from pelvic floor function.Also, it has been demonstrated that, after physical therapy, pelvic floor muscle was strengthened and it became fully continent of bowel in home and community settings. Therefore, constipation is one of the manifestations of pelvic floor dysfunction in children, surface electromyography assessment and anorectal manometry are helpful for the diagnosis of pelvic floor dysfunction in children.
Sacral nerve electrical stimulation combined with pelvic floor rehabilitation(PFR) is an effective method for the treatment of pelvic floor dysfunction. At present, there are many methods for sacral neuromodulation(SNM). Percutaneous sacral nerve stimulation is a effective method for sacral neuromodulation discovered in recent years. Studies have shown the efficacy of simultaneous SNM and PFR for the treatment of childhood constipation. This method is not only better than pelvic floor training and conventional treatment, but also safe and non-invasive. At present, there are many methods for SNM. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as SNM, and has the advantages of small trauma, safety, and convenience. PTNS has become a very effective method for SNM in recent years. Carlo Vecchioli Scaldazza et al. demonstrates the effectiveness of PTNS in women with over active bladder, improving their pelvic floor function. The result suggests that percutaneous artificial stimulation combined with PFR can be used for the treatment of constipation, especially in those with secondary pelvic floor dysfunction.
Therefore, for the treatment of intractable constipation in children, it is also necessary to determine whether there is pelvic floor dysfunction involved. In the children with pelvic floor dysfunction, relieving the pelvic floor dysfunction is an important treatment principle for the treatment of constipation. PTNS in combination with PFR offers a novel approach for the treatment of pelvic floor dysfunction and intractable constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. In this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.
- Conditions
- Constipation, Childhood ALL, Pelvic Floor Disorders
- Being tested
- PTNS, Sham PTNS
- Medical subject headings
- Constipation, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTNSDevice
Also called PFR
PTNS and PFR
Sham PTNSDevice
Also called PFR
Sham PTNS and PFR
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | PTNS and PFR (twice daily) Receives: Device: PTNS |
| Control group | Experimental | Sham PTNS and PFR (twice daily) Receives: Device: Sham PTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
Measured: Baseline
change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
Measured: at the end of 4-weeks PTNS and PFR treatment
change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
Measured: at the end of 12 weeks follow-up
Satisfaction with bowel function
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Measured: Baseline
Satisfaction with bowel function Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Measured: at the end of 4-weeks PTNS and PFR treatment
Satisfaction with bowel function Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Measured: at the end of 12 weeks follow-up
Secondary outcomes (15)
Bowel movements the frequency of bowel movements per week
Rate of bowel movements per week;Incidence of constipation.
Measured: Baseline
Bowel movements
Rate of bowel movements per week;Incidence of constipation.
Measured: at the end of 4-weeks PTNS and PFR treatment
Bowel movements
Rate of bowel movements per week;Incidence of constipation.
Measured: at the end of 12 weeks follow-up
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Measured: Baseline
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Measured: at the end of 4-weeks PTNS and PFR treatment
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Measured: at the end of 12 weeks follow-up
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Measured: Baseline
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Measured: at the end of 4-weeks PTNS and PFR treatment
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Measured: at the end of 12 weeks follow-up
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Measured: Baseline
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Measured: at the end of 4-weeks PTNS and PFR treatment
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Measured: at the end of 12 weeks follow-up
Encopresis
Incidence of fecal incontinence
Measured: Baseline
Encopresis
Incidence of fecal incontinence
Measured: at the end of 4-weeks PTNS and PFR treatment
Encopresis
Incidence of fecal incontinence
Measured: at the end of 12 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start8 May 2019
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shucheng Zhang, Shengjing Hospital
- Investigators
- Shucheng ZHANG, Study chair, Shengjing HospitalZhengTong YU, Study director, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059756
- Sponsor's protocol ID
- A333
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zar-Kessler C, Kuo B, Cole E, Benedix A, Belkind-Gerson J. Benefit of Pelvic Floor Physical Therapy in Pediatric Patients with Dyssynergic Defecation Constipation. Dig Dis. 2019;37(6):478-485. doi: 10.1159/000500121. Epub 2019 May 16.
PubMed 31096249Scaldazza CV, Morosetti C, Giampieretti R, Lorenzetti R, Baroni M. Percutaneous tibial nerve stimulation versus electrical stimulation with pelvic floor muscle training for overactive bladder syndrome in women: results of a randomized controlled study. Int Braz J Urol. 2017 Jan-Feb;43(1):121-126. doi: 10.1590/S1677-5538.IBJU.2015.0719.
PubMed 28124534
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation
- ClinicalTrials.gov ID
- NCT05059756
- Acronym / sponsor ID
- A333
- Conditions
- Constipation, Childhood ALL, Pelvic Floor Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 28 Sep 2021 (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.
Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of children's constipation is full of challenges, and treatment methods are diverse.
Studies have shown that pelvic floor dysfunction is a common cause of intractable constipation in children. Zhang et al. have confirmed the role of pelvic floor dysfunction in pediatric constipation. At present, the main methods for pelvic floor dysfunction include surface electromyography and anorectal manometry which have been widely used in children with constipation and they are helpful for the diagnosis of pelvic floor dysfunction in children with constipation.
Sacral nerve electrical stimulation combined with pelvic floor rehabilitation is an effective method for the treatment of pelvic floor dysfunction. It offers a novel approach for the treatment of intractable constipation with pelvic floor dysfunction . At present, there are many methods for sacral nerve regulation. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as sacral nerve regulation, and has the advantages of small trauma, safety, and convenience. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. Therefore, in this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.
Detailed description
Constipation is the most common complaint in childhood, affecting an estimated 20% of children globally. At present, the treatment of childhood constipation is full of challenges, and treatment methods are diverse. For example, diet control, behavioral intervention and oral Laxative, bowl management, surgical treatment and other methods can be used for the treatment of childhood constipation. Therefore, a number of guidelines for constipation in children have been developed to regulate the treatment of constipation in children. Fiber intake and polyethylene glycol are recommended as the first line choice for constipation in North American and European guidelines. However, through clinical tests, the effectiveness of PEG3350 laxative and fiber does not last, or it does not work after long-term use. Therefore, additional treatment interventions are necessary. Zhang et al. applied traditional Chinese medicine to treat childhood constipation, which greatly improved the efficacy and reduced the recurrence rate, but there were still nearly 30% intractable constipation left, and other treatment methods were needed.
Studies have shown that secondary pelvic floor dysfunction is a common cause of intractable constipation in children. The incidence of pelvic floor dysfunction is high in children with constipation, and it has a great impact on the symptoms of constipation. Zhang et al. applied defecography to examine 76 children with constipation and found that there existed different pelvic floor dysfunction such as rectocele, puborectal muscle spasm, pelvic floor spasm syndrome and sigmoid hernia in the defecation of children with constipation. In addition, the pelvic floor dysfunction in children was mainly spastic, while in adults it was mainly flaccid. Although these results confirm the role of pelvic floor dysfunction in pediatric constipation, the pelvic floor function was not evaluated. At present, the main methods for pelvic floor function include surface electromyography and anorectal manometry.
Based on the above theory, Claire Zar-Kessler et al. completed a retrospective study of 69 children in which researchers compared the clinical outcome of patients who underwent pelvic floor physical therapy (n = 49) to control patients (n = 20) whom received only medical treatment (laxatives/stool softeners), determined by anorectal manometry and balloon expulsion testing and come to the conclusion that the new field of pelvic floor physical therapy is a safe and effective intervention for children with dyssynergic defecation causing or contributing to chronic constipation. In recent years, more and more studies have confirmed that childhood constipation is resulted from pelvic floor function.Also, it has been demonstrated that, after physical therapy, pelvic floor muscle was strengthened and it became fully continent of bowel in home and community settings. Therefore, constipation is one of the manifestations of pelvic floor dysfunction in children, surface electromyography assessment and anorectal manometry are helpful for the diagnosis of pelvic floor dysfunction in children.
Sacral nerve electrical stimulation combined with pelvic floor rehabilitation(PFR) is an effective method for the treatment of pelvic floor dysfunction. At present, there are many methods for sacral neuromodulation(SNM). Percutaneous sacral nerve stimulation is a effective method for sacral neuromodulation discovered in recent years. Studies have shown the efficacy of simultaneous SNM and PFR for the treatment of childhood constipation. This method is not only better than pelvic floor training and conventional treatment, but also safe and non-invasive. At present, there are many methods for SNM. Percutaneous tibial nerve stimulation (PTNS), another peripheral nerve electrical stimulation approved by the United States Food and Drug Administration, has the same effect as SNM, and has the advantages of small trauma, safety, and convenience. PTNS has become a very effective method for SNM in recent years. Carlo Vecchioli Scaldazza et al. demonstrates the effectiveness of PTNS in women with over active bladder, improving their pelvic floor function. The result suggests that percutaneous artificial stimulation combined with PFR can be used for the treatment of constipation, especially in those with secondary pelvic floor dysfunction.
Therefore, for the treatment of intractable constipation in children, it is also necessary to determine whether there is pelvic floor dysfunction involved. In the children with pelvic floor dysfunction, relieving the pelvic floor dysfunction is an important treatment principle for the treatment of constipation. PTNS in combination with PFR offers a novel approach for the treatment of pelvic floor dysfunction and intractable constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by PTNS combine with PFR. In this study, a randomized, controlled, double-blind clinical trial was designed to confirm the efficacy and safety of PTNS combine with PFR in the treatment of childhood constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: PTNSPTNS and PFR (twice daily) |
| Control group | Experimental | Device: Sham PTNSSham PTNS and PFR (twice daily) |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 4-14 years old;
- Meeting the Roman IV criteria for childhood constipation;
- After one course of PEG and one course of Chinese medicine treatment, it was ineffective;
- Pelvic floor surface electromyography (EMG) and 3-D manometry of the anus revealed pelvic floor dysfunction
- The onset of intestinal stenosis due to organic diseases (such as anal fissure, inflammation, intestinal polyps, intestinal adhesion, Crohn's disease, intestinal tuberculosis, tumor, etc.);
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 |
|---|---|---|
| PTNSAlso: PFRPTNS and PFR | Device | Treatment group |
| Sham PTNSAlso: PFRSham PTNS and PFR | Device | Control group |
Primary outcome
change of CSBMs (sub/week) from baseline
Time frame: Baseline
Rate of defecation without drugs or other auxiliary methods
change of CSBMs (sub/week) from baseline
Time frame: at the end of 4-weeks PTNS and PFR treatment
Rate of defecation without drugs or other auxiliary methods
change of CSBMs (sub/week) from baseline
Time frame: at the end of 12 weeks follow-up
Rate of defecation without drugs or other auxiliary methods
Satisfaction with bowel function
Time frame: Baseline
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).
Time frame: at the end of 4-weeks PTNS and PFR treatment
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Satisfaction with bowel function Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
Time frame: at the end of 12 weeks follow-up
Satisfaction with bowel function was collected from the parents and defined as the number of which were satisfied with bowel function after the treatment (yes or no).
15 secondary outcomes
Bowel movements the frequency of bowel movements per week
Time frame: Baseline
Bowel movements
Time frame: at the end of 4-weeks PTNS and PFR treatment
Bowel movements
Time frame: at the end of 12 weeks follow-up
Painful or hard bowel movements
Time frame: Baseline
Painful or hard bowel movements
Time frame: at the end of 4-weeks PTNS and PFR treatment
Painful or hard bowel movements
Time frame: at the end of 12 weeks follow-up
Large diameter or scybalous stools
Time frame: Baseline
Large diameter or scybalous stools
Time frame: at the end of 4-weeks PTNS and PFR treatment
Large diameter or scybalous stools
Time frame: at the end of 12 weeks follow-up
Excessive volitional stool retention
Time frame: Baseline
Excessive volitional stool retention
Time frame: at the end of 4-weeks PTNS and PFR treatment
Excessive volitional stool retention
Time frame: at the end of 12 weeks follow-up
Encopresis
Time frame: Baseline
Encopresis
Time frame: at the end of 4-weeks PTNS and PFR treatment
Encopresis
Time frame: at the end of 12 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 31096249Zar-Kessler C, Kuo B, Cole E, Benedix A, Belkind-Gerson J. Benefit of Pelvic Floor Physical Therapy in Pediatric Patients with Dyssynergic Defecation Constipation. Dig Dis. 2019;37(6):478-485. doi: 10.1159/000500121. Epub 2019 May 16.
- Results publication: PubMed 28124534Scaldazza CV, Morosetti C, Giampieretti R, Lorenzetti R, Baroni M. Percutaneous tibial nerve stimulation versus electrical stimulation with pelvic floor muscle training for overactive bladder syndrome in women: results of a randomized controlled study. Int Braz J Urol. 2017 Jan-Feb;43(1):121-126. doi: 10.1590/S1677-5538.IBJU.2015.0719.
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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.
Shucheng ZHANG study chair
Shengjing Hospital
ZhengTong YU study director
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTNS in people with Constipation and Childhood ALL, run by Shengjing Hospital at 1 site in China.
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 13 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of CSBMs (sub/week) from baseline (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05059756, which also lists 2 linked publications.
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 22 Nov 2023.