| Objective: Constipation is one of the common digestive tract symptoms in childhood,affecting the health of 1%-30% of children.It is reported that children with pelvic floor dysfunction constipation have anorectal dynamic abnormalities and dysesthesia of defecation,and pelvic floor dysfunction is one of the most common causes of constipation in children.Pelvic floor dysfunction in children includes spasms,achalasia,and contradictory contractions of the anal sphincter and puborectum muscles.Studies showed that percutaneous tibial nerve stimulation(PTNS)with pelvic floor exercises(PFEs)has achieved a satisfactory outcome in the elderly and women with PFD.However,the efficacy of PTNS with PFEs in childhood constipation has not been established.The purpose of this study was to verify the efficacy of both methods in the treatment of constipation in children.Methods: A randomized,double-blind,controlled trial with 84 children who met the inclusion criteria was conducted.All participants were randomly assigned to PTNS with PFEs or sham PTNS with PFEs groups and received their individual intervention for 4 weeks with a 12-week follow-up evaluation.The changes of spontaneous bowel movements(SBMs)from baseline were the main outcomes and the risk ratio(RR)with 95%confidence interval(CI)were calculated.The secondary outcomes included large diameter or scybalous stools,painful or hard bowel movements,excessive volitional stool retention,and encopresis.Full remission was defined as improvement in SBMs ≥ 3 per week from baseline along with most or all secondary outcomes recovered.Improvement was defined as improvement in SBMs ≥ 3 per weeks with at least one secondary outcome recovered.Patients without recovery of both primary and secondary outcomes were considered invalid.The effectiveness and recurrence rates were calculated by counting the number of full remissions,improvement,and invalid based on SBMs.High-resolution anorectal manometry and surface electromyography were used for assessment of pelvic floor function,and the adverse effects were assessed based on symptoms.Results: At the end of treatment,29 patients(69.0%)in the PTNS with PFEs group and15 patients(35.7%)in the control group had SBM≥3 per week from baseline(Net difference was 33.3%,95%CI: 13.2%-53.5%;RR: 3.000,95%CI: 1.612-5.585;P < 0.05).At the end of the 12-week follow-up,SBM≥3 per week from baseline had 22(52.4%)in PTNS with PFEs group and 8(19.0%)in the control group.(Net difference was 33.4%,95%CI: 14.1%-52.5%;RR: 2.750,95%CI: 1.384-5.466;P < 0.05).By using the mixed effects linear regression model,the results of secondary evaluation indicators were obtained at the end of follow-up: 31 patients(73.8%)in the PTNS with PFEs group and23 patients(54.8%)in the control group had improved symptoms of Large diameter or scybalous stools.(Net difference was 19%,95%CI: 21.0%-39.1%;RR: 1.348,95%CI:0.970-1.872;P < 0.05);33 patients(78.6%)in the PTNS with PFEs group and 24 patients(57.1%)in the control group had improved symptoms of painful or hard bowel movements.(Net difference was 21.5%,95%CI: 2.0%-40.9%;RR: 1.375,95%CI: 1.013-1.867;P <0.05);35 cases(83.3%)in PTNS with PFEs and 26 cases(61.9%)in the control group showed improvement in excessive volitional stool retention symptoms.(Net difference was 21.4%,95%CI: 2.9-39.9%;RR: 1.346,95%CI: 1.024-1.769;P < 0.05);The symptoms of encopresis were improved in 36 cases(85.7%)of PTNS with PFEs and 23 cases(54.8%)of control group.(Net difference was 30.9%,95%CI: 12.6%-49.4%;RR: 1.565,95%CI:1.158-2.116;P < 0.05).At the end of follow-up,a total of 75 children had completed high resolution anorectal manometry and surface electromyography assessment.PFD remission occurred in 49 children,33(78.6%)in the PTNS with PFEs group and 16(38.1%)in the sham group(RR 2.063,95% CI 1.360 to 3.128,P<0.05).No adverse effects occurred.Conclusion: PTNS with PFEs is a safe and effective method in the treatment of childhood constipation,particularly in children with PFD or dyssynergic defecation. |
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