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PTNS and PFR in the Treatment of Childhood Constipation

Primary Purpose

Constipation, Childhood ALL, Pelvic Floor Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
PTNS
Sham PTNS
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.);
  • 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.

Sites / Locations

  • Shengjing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group

Control group

Arm Description

PTNS and PFR (twice daily)

Sham PTNS and PFR (twice daily)

Outcomes

Primary Outcome Measures

change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
change of CSBMs (sub/week) from baseline
Rate of defecation without drugs or other auxiliary methods
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 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).
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).

Secondary Outcome Measures

Bowel movements the frequency of bowel movements per week
Rate of bowel movements per week;Incidence of constipation.
Bowel movements
Rate of bowel movements per week;Incidence of constipation.
Bowel movements
Rate of bowel movements per week;Incidence of constipation.
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Painful or hard bowel movements
The feelings of children during defecation;Rate of painful or hard bowel movements.
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Large diameter or scybalous stools
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Excessive volitional stool retention
Rate of children who intentionally control or reduce the frequency of defecation.
Encopresis
Incidence of fecal incontinence
Encopresis
Incidence of fecal incontinence
Encopresis
Incidence of fecal incontinence

Full Information

First Posted
September 6, 2021
Last Updated
September 26, 2021
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05059756
Brief Title
PTNS and PFR in the Treatment of Childhood Constipation
Official Title
Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2020 (Actual)
Primary Completion Date
May 8, 2022 (Anticipated)
Study Completion Date
September 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Childhood ALL, Pelvic Floor Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
PTNS and PFR (twice daily)
Arm Title
Control group
Arm Type
Experimental
Arm Description
Sham PTNS and PFR (twice daily)
Intervention Type
Device
Intervention Name(s)
PTNS
Other Intervention Name(s)
PFR
Intervention Description
PTNS and PFR
Intervention Type
Device
Intervention Name(s)
Sham PTNS
Other Intervention Name(s)
PFR
Intervention Description
Sham PTNS and PFR
Primary Outcome Measure Information:
Title
change of CSBMs (sub/week) from baseline
Description
Rate of defecation without drugs or other auxiliary methods
Time Frame
Baseline
Title
change of CSBMs (sub/week) from baseline
Description
Rate of defecation without drugs or other auxiliary methods
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
change of CSBMs (sub/week) from baseline
Description
Rate of defecation without drugs or other auxiliary methods
Time Frame
at the end of 12 weeks follow-up
Title
Satisfaction with bowel function
Description
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
Baseline
Title
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).
Description
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 4-weeks PTNS and PFR treatment
Title
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).
Description
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
Secondary Outcome Measure Information:
Title
Bowel movements the frequency of bowel movements per week
Description
Rate of bowel movements per week;Incidence of constipation.
Time Frame
Baseline
Title
Bowel movements
Description
Rate of bowel movements per week;Incidence of constipation.
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
Bowel movements
Description
Rate of bowel movements per week;Incidence of constipation.
Time Frame
at the end of 12 weeks follow-up
Title
Painful or hard bowel movements
Description
The feelings of children during defecation;Rate of painful or hard bowel movements.
Time Frame
Baseline
Title
Painful or hard bowel movements
Description
The feelings of children during defecation;Rate of painful or hard bowel movements.
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
Painful or hard bowel movements
Description
The feelings of children during defecation;Rate of painful or hard bowel movements.
Time Frame
at the end of 12 weeks follow-up
Title
Large diameter or scybalous stools
Description
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Time Frame
Baseline
Title
Large diameter or scybalous stools
Description
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
Large diameter or scybalous stools
Description
Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.
Time Frame
at the end of 12 weeks follow-up
Title
Excessive volitional stool retention
Description
Rate of children who intentionally control or reduce the frequency of defecation.
Time Frame
Baseline
Title
Excessive volitional stool retention
Description
Rate of children who intentionally control or reduce the frequency of defecation.
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
Excessive volitional stool retention
Description
Rate of children who intentionally control or reduce the frequency of defecation.
Time Frame
at the end of 12 weeks follow-up
Title
Encopresis
Description
Incidence of fecal incontinence
Time Frame
Baseline
Title
Encopresis
Description
Incidence of fecal incontinence
Time Frame
at the end of 4-weeks PTNS and PFR treatment
Title
Encopresis
Description
Incidence of fecal incontinence
Time Frame
at the end of 12 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.); 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shucheng ZHANG
Phone
86-24-96615-57911
Email
zhangshucheng76@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shucheng ZHANG
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
ZhengTong YU
Organizational Affiliation
Shengjing Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shucheng ZHANG
Phone
86-24-96615-57911
Email
zhangshucheng76@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
31096249
Citation
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.
Results Reference
background
PubMed Identifier
28124534
Citation
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.
Results Reference
result

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PTNS and PFR in the Treatment of Childhood Constipation

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