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PTNS and PFR in the Treatment of Childhood Constipation

NCT05059756 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-11-22

No results posted yet for this study

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

Interventions

DEVICE

PTNS

PTNS and PFR

DEVICE

Sham PTNS

Sham PTNS and PFR

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Principal Investigators

  • Shucheng ZHANG · Shengjing Hospital

  • ZhengTong YU · Shengjing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2021-12-08
Completion
2021-12-08

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05059756 on ClinicalTrials.gov