NCT05059756

PTNS and PFR in the Treatment of Childhood Constipation

Completed NA Last updated 22 November 2023

What this trial tests

NA trial testing PTNS in Constipation in 84 participants. Completed in 8 December 2021.

Timeline

8 May 2019

Primary endpoint
8 December 2021

8 December 2021

Quick facts

Lead sponsor	Shengjing Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	84
Start date	8 May 2019
Primary completion	8 December 2021
Estimated completion	8 December 2021
Sites	1 location across China

Drugs / interventions tested

• PTNS
• Sham PTNS

Conditions studied

• Constipation — all drugs for Constipation →
• Childhood ALL — all drugs for Childhood ALL →
• Pelvic Floor Disorders — all drugs for Pelvic Floor Disorders →

Sponsor

Shengjing Hospital

Who can join

Adults 10 to 14, any sex, with Constipation or Childhood ALL. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Treatments for intractable constipation in childhood.
   Gordon M, Grafton-Clarke C, Rajindrajith S, Benninga MA, et al · · 2024 · cited 2× · PMID 38895907 · DOI 10.1002/14651858.cd014580.pub2