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.