A protocol for an interventional study on the impact of transcutaneous parasacral nerve stimulation in children with functional constipation

INTRODUCTION: Transcutaneous parasacral nerve stimulation (TPNS) via electrodes placed over the sacrum can activate afferent neuronal networks noninvasively, leading to sacral reflexes that may improve colonic motility. Thus, TPNS can be considered a promising, noninvasive, and safe method for the treatment of constipation. However, there is no published study investigating its use in children with functional constipation. This is a single-center, prospective, longitudinal, and interventional study designed to assess the applicability and clinical outcomes of TPNS in functionally constipated children. PATIENT CONCERNS: Parents or guardians of patients will be informed of the purpose of the study and will sign an informed consent form. The participants may leave the study at any time without any restrictions. DIAGNOSIS: Twenty-eight children (7–18 years old) who were diagnosed with intestinal constipation (Rome IV criteria) will be included. INTERVENTIONS: The patients will be submitted to daily sessions of TPNS for a period of 4 or 8 weeks and will be invited to participate in semistructured interviews at 3 or 4 moments: 1 week before the beginning of TPNS; immediately after the 4 and/or 8 weeks of TPNS; and 4 weeks after the end of the intervention period. In these appointments, the aspects related to bowel habits and quality of life will be assessed. OUTCOMES: This study will evaluate the increase in the number of bowel movements and stool consistency, the decrease in the number of episodes of retentive fecal incontinence, and the indirect improvement in the overall quality of life. CONCLUSION: we expect that this study protocol can show the efficacy of this promising method to assist the treatment of children with functional constipation.