PTNS and PFR in the Treatment of Childhood Constipation

Percutaneous Tibial Nerve Stimulation and Pelvic Floor Rehabilitation in the Treatment of Childhood Constipation

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Pelvic Floor Disorders; Childhood ALL
• Intervention / Treatment: Device: PTNS; Device: Sham PTNS

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; PTNS and PFR (twice daily)	Device: PTNS; PTNS and PFR; Other Names: PFR
Experimental: Control group; Sham PTNS and PFR (twice daily)	Device: Sham PTNS; Sham PTNS and PFR; Other Names: PFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel movements the frequency of bowel movements per week	Rate of bowel movements per week;Incidence of constipation.	Baseline
Bowel movements	Rate of bowel movements per week;Incidence of constipation.	at the end of 4-weeks PTNS and PFR treatment
Bowel movements	Rate of bowel movements per week;Incidence of constipation.	at the end of 12 weeks follow-up
Painful or hard bowel movements	The feelings of children during defecation;Rate of painful or hard bowel movements.	Baseline
Painful or hard bowel movements	The feelings of children during defecation;Rate of painful or hard bowel movements.	at the end of 4-weeks PTNS and PFR treatment
Painful or hard bowel movements	The feelings of children during defecation;Rate of painful or hard bowel movements.	at the end of 12 weeks follow-up
Large diameter or scybalous stools	Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.	Baseline
Large diameter or scybalous stools	Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.	at the end of 4-weeks PTNS and PFR treatment
Large diameter or scybalous stools	Appearance and wetness of stool; Rate of patients with large diameter or scybalous stools.	at the end of 12 weeks follow-up
Excessive volitional stool retention	Rate of children who intentionally control or reduce the frequency of defecation.	Baseline
Excessive volitional stool retention	Rate of children who intentionally control or reduce the frequency of defecation.	at the end of 4-weeks PTNS and PFR treatment
Excessive volitional stool retention	Rate of children who intentionally control or reduce the frequency of defecation.	at the end of 12 weeks follow-up
Encopresis	Incidence of fecal incontinence	Baseline
Encopresis	Incidence of fecal incontinence	at the end of 4-weeks PTNS and PFR treatment
Encopresis	Incidence of fecal incontinence	at the end of 12 weeks follow-up

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Investigators: Study Chair: Shucheng ZHANG, Shengjing Hospital; Study Director: ZhengTong YU, Shengjing Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2019
• Primary Completion (Actual): December 8, 2021
• Study Completion (Actual): December 8, 2021

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): September 28, 2021

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Signs and Symptoms, Digestive; Pregnancy Complications; Leukemia, Lymphoid; Leukemia; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Constipation; Pelvic Floor Disorders
• Other Study ID Numbers: A333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No