PTNS and PFR in the Treatment of Childhood Constipation

NCT05059756 | Completed

• 1 other identifier: A333
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Childhood ALL; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (6)

• change of CSBMs (sub/week) from baseline

  Rate of defecation without drugs or other auxiliary methods

  Baseline

• change of CSBMs (sub/week) from baseline

  Rate of defecation without drugs or other auxiliary methods

  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

  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).

  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).

  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).

  at the end of 12 weeks follow-up

Secondary Outcomes (15)

• Bowel movements the frequency of bowel movements per week

  Baseline

• Bowel movements

  at the end of 4-weeks PTNS and PFR treatment

• Bowel movements

  at the end of 12 weeks follow-up

• Painful or hard bowel movements

  Baseline

• Painful or hard bowel movements

  at the end of 4-weeks PTNS and PFR treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

PTNS and PFR (twice daily)

Device: PTNS

Control group

EXPERIMENTAL

Sham PTNS and PFR (twice daily)

Device: Sham PTNS

Interventions

PTNS DEVICE

PTNS and PFR

Also known as: PFR

Treatment group

Sham PTNS DEVICE

Sham PTNS and PFR

Also known as: PFR

Control group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Publications (2)

• 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.

  PMID: 31096249 BACKGROUND

• 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.

  PMID: 28124534 RESULT

MeSH Terms

Conditions

Constipation; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Shucheng ZHANG

  Shengjing Hospital

  STUDY CHAIR

• ZhengTong YU

  Shengjing Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 28, 2021
• Study Start: May 8, 2019
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)