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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

China1 site
  • Shengjing Hospital

    Shenyang, Liaoning, 110004

Other trials in China

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.

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 groups in NCT05059756
Study groupRoleWhat they receive
Treatment groupExperimentalPTNS and PFR (twice daily)
Receives: Device: PTNS
Control groupExperimentalSham 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.

  1. change of CSBMs (sub/week) from baseline

    Rate of defecation without drugs or other auxiliary methods

    Measured: Baseline

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)
  1. Bowel movements the frequency of bowel movements per week

    Rate of bowel movements per week;Incidence of constipation.

    Measured: Baseline

  2. Bowel movements

    Rate of bowel movements per week;Incidence of constipation.

    Measured: at the end of 4-weeks PTNS and PFR treatment

  3. Bowel movements

    Rate of bowel movements per week;Incidence of constipation.

    Measured: at the end of 12 weeks follow-up

  4. Painful or hard bowel movements

    The feelings of children during defecation;Rate of painful or hard bowel movements.

    Measured: Baseline

  5. 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

  6. 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

  7. Large diameter or scybalous stools

    Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.

    Measured: Baseline

  8. 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

  9. 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

  10. Excessive volitional stool retention

    Rate of children who intentionally control or reduce the frequency of defecation.

    Measured: Baseline

  11. 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

  12. 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

  13. Encopresis

    Incidence of fecal incontinence

    Measured: Baseline

  14. Encopresis

    Incidence of fecal incontinence

    Measured: at the end of 4-weeks PTNS and PFR treatment

  15. 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.

  1. First posted28 Sep 2021
  2. Study start8 May 2019
  3. Primary completion8 Dec 2021
  4. Study completion8 Dec 2021

Resources

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)
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 31096249
  • Scaldazza 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

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.

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