PTNS and PFR in the Treatment of Childhood Constipation
Condition: Constipation; Childhood ALL; Pelvic Floor Disorders
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pelvic Floor Disorders; Constipation
Study type: Interventional

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.
    

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.
    

Intervention name(s): PTNS; Sham PTNS
Intervention type(s): Device; Device
Intervention description(s): PTNS and PFR; Sham PTNS and PFR
Other intervention name(s): PFR; PFR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group: PTNS and PFR treatment; Control group: ( Sham stimulation and PFR training)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment