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Evaluation of the initial impact of transcutaneous parasacral nerve stimulation early in the treatment of refractory functional constipation in children and adolescents

Grant number: 20/16302-0
Support Opportunities:Scholarships in Brazil - Scientific Initiation
Effective date (Start): April 01, 2021
Effective date (End): March 31, 2022
Field of knowledge:Health Sciences - Medicine - Surgery
Principal Investigator:Pedro Luiz Toledo de Arruda Lourencao
Grantee:Stefani Rabelo Vieira
Host Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil


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: 28 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: one 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.

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