Long Term Outcome of Transcutaneous Posterior Tibial Nerve Stimulation in Treatment of Functional Non-Retentive Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Number of incontinence episodes
研究概览
简要总结
Shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (PTNS) for FI, and they documented improved continence after 4 weeks course. Subsequent studies documented percutaneous and transcutaneous PTNS as effective methods for treatment of FI, with a short term reduction in incontinence episode by 50-80 %. Percutaneous PTNS (PPTNS) showed a greater effect than transcutaneous PTNS (TPTNS) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. However, TPTNS is more preferable to percutaneous PTNS because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.
详细描述
Treatment of FNRFI is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. The corner-stones in treatment of FNRFI are education, positive motivation, and toilet training. Preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. The main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges.
Many previous studies, reported the short term effect of TPTNS in treatment of FNRFI. However, there are sufficient studies evaluating the long term effect of TPNS and this has motivated the authors to conduct of this study The aim of this study is to evaluate the Long term outcome and quality of life in children with Functional non-retentive fecal incontinence and received Bilateral Transcutaneous posterior tibial nerve stimulation therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranged from (6-14 years) with FNRFI with normal bowel habits
- •Children with normal defecation frequency and normal stool consistency
- •Children with incontinence score ranging from 8-22 according to Vaizey score
排除标准
- •Children who have traumatic sphincter injury.
- •Children who have Fecal impaction
- •Children who have Spinal diseases causing incontinence
- •Children who have Anorectal malformation
- •Children who were not cooperative
结局指标
主要结局
Number of incontinence episodes
时间窗: 24 months
Change in the number of incontinence episodes
Incontinence Score using Vaizey incontinence score
时间窗: 24 months
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
次要结局
- First Urge (volume of the balloon by cm water)(3 months)
- Fecal Incontinence Quality of life Score(24 months)
- First sensation (volume of the balloon by cm water)(3 months)
- Resting pressure (mm hg)(3 months)
- Squeeze pressure (mm hg)(3 months)
研究者
Mohamed A. Abdel Ghafar
Associate Professor
Batterjee Medical College