Clinical trial · Interventional
PTNS and PFR in the Treatment of Childhood Constipation
Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Constipation | — | UNRESOLVED | — |
| Pelvic Floor Disorders | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTNS | Device | — | UNRESOLVED |
| Sham PTNS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- PTNS and PFR (twice daily)
- interventionNames
- Device: PTNS
- type
- EXPERIMENTAL
- label
- Control group
- description
- Sham PTNS and PFR (twice daily)
- interventionNames
- Device: Sham PTNS
Primary outcomes (6)
- measure
- change of CSBMs (sub/week) from baseline
- timeFrame
- Baseline
- description
- Rate of defecation without drugs or other auxiliary methods
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDZar-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
- RESULTScaldazza 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