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临床试验/NCT07099339
NCT07099339已完成不适用

Effect of Pudendal Nerve Electrical Stimulation on Fecal Incontinence in Children With Repaired Anorectal Malformation: A Randomized Controlled Clinical Trial

Sinai University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年11月2日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
2
主要终点
Anal Sphincter Muscles Activity Peak

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate the effect of pudendal nerve electrical stimulation on fecal incontinence in children with repaired anorectal malformation. Ithe investigators are hypothesized that PNES will significantly improve continence scores, reduce the frequency of fecal incontinent episodes, and enhance the overall quality of life in this vulnerable pediatric population, thereby addressing a critical unmet need in their long-term care.

Children with repaired anorectal malformation may benefit more from combined pudendal nerve electrical stimulation with behavioral therapy and pelvic floor muscles training in improving fecal incontinence.

详细描述

Anorectal malformation (ARM), commonly known as imperforate anus, represent a spectrum of congenital anomalies where the anus and rectum do not form properly during fetal development, these malformations vary widely in severity, from a simple membrane covering the anal opening to complex defects cloacal malformations involving abnormal connections (fistulas) to the urinary or genital tracts.

Fecal incontinence in this population can stem from various factors, including impaired anorectal sensation, compromised sphincter function, and abnormal bowel motility, severely impacting a child's quality of life, psychosocial development, and integration into social activities.

Current management strategies for FI in children with repaired ARM typically involve a multi-faceted approach, including dietary modifications, laxatives, enemas, and bowel management programs.

Exercises such as Kegels, where children are taught to contract and relax these muscles, are commonly employed to enhance voluntary control and improve the ability to hold stool.

The pudendal nerve plays a vital role in maintaining fecal continence by innervating the external anal sphincter EAS bilaterally by the somatic fibers of the 2nd, 3rd, and 4th sacral roots through its connections to the sacral reflex arc, contributing to rectal sensation, and coordinating pelvic floor muscle function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

the assessor didn't know the grouping of children, intervention received, the data of first assessment.

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children ages ranged from 6 to 9 years and complain of involuntary leakage of feces with a history of anorectal surgical repair MRI revealed the degree of muscle development "Fair/Hypoplastic" identifiable but less developed or asymmetrical muscles
  • they can do minimal palpable voluntary contraction of anal sphincter muscle
  • they were able to follow instructions during the testing and treatment procedures.

排除标准

  • with severe hypoplasia or complete agenesis/absence of parts of the sphincter complex "Poor/Barely Identifiable/Absent", evidenced by MRI,
  • children with post-colon surgery other than ARM, neurologic/neuropathic disorder, spinal cord lesion, sensory or hearing deficits.

结局指标

主要结局

Anal Sphincter Muscles Activity Peak

时间窗: Baseline and after three months

Anal Sphincter Muscle Activity Peak was evaluated using anal pressure sensor (in mmHg) = anal squeeze pressure during maximum voluntary contraction - resting anal pressure at rest or resting tone as baseline activity.

次要结局

  • Defecation Frequency(Baseline and after three months)
  • Fecal Leakage Episodes(Baseline and after three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amany Gomaa Atiaa

lecturer

Sinai University

研究点 (2)

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