Biofeedback Versus Bilateral Transcutaneous Electrical Nerve Stimulation in the 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
- 93
- 试验地点
- 1
- 主要终点
- Incontinence score using St' Mark's (Vaiszey)
研究概览
简要总结
Fecal incontinence is one of the most psychological frustrating problems. It occurs in children due to many causes. There is a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation. However, up till now, there are no established guidelines for treatment.
the objective of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPNS) as non-invasive methods in the treatment of functional non-retentive fecal incontinence (FNRFI) in children.
详细描述
Functional non-retentive fecal incontinence (FNRFI) requires prolonged treatment with a wide range of non-invasive therapeutic approaches like Kegel exercise, Biofeedback, and posterior tibial nerve stimulation (PTNS). However, up till now, there are no established guidelines for treatment.1 The aim of this study is to evaluate and compare the early effect of Biofeedback therapy versus bilateral transcutaneous posterior tibial nerve stimulation (TPTNS) as non-invasive methods in the treatment of (FNRFI) in children.
Methodology: The current prospective randomized controlled study included 93 children with FNRFI who were randomly divided and allocated into three groups. Group A treated by conventional methods through dietetic regulation and Kegal exercises. Group B treated by biofeedback therapy while group C received bilateral (TPTNS). Initial manometric findings including resting pressure, squeeze pressure, 1st sensation, 1st urge, and intense urge were recorded and repeated after 3 and 6 months together with incontinence score recorded in using St' Mark's (Varizey) with the primary endpoint of improvement of the incontinence score more than 50%.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FecaI incontinence
- •Normal defecation frequency,
- •Normal bowel habits and
- •Normal stool consistency
排除标准
- •Children who are not cooperative,
- •Children with traumatic sphincter injury,
- •Children with fecal impaction,
- •Children with spinal diseases causing incontinence,
- •Children with anorectal malformation,
研究组 & 干预措施
Biofeedback
Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210).
干预措施: Biofeedback (Device)
Electrical Stimulation
Bilateral (TPTNS); was applied with an electrode above the medial malleolus A second electrode) was applied just below the same malleolus. Electrical stimulation with a low-frequency current (10 Hz), and adjustable intensity. The procedure was done for 20-30 minutes, three times per week for 3 months together with the conventional maneuvers applied in the control group.
干预措施: Electrical stimulation (Device)
Control group
were managed by conventional methods through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.
干预措施: Traditional treatment (Other)
结局指标
主要结局
Incontinence score using St' Mark's (Vaiszey)
时间窗: 3 months after intervention
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
incontinence score using St' Mark's (Vaiszey)
时间窗: 6 months after intervention
Questionnaire ranging from zero (indicating complete continence) to 24 (indicating total incontinence).
次要结局
- Resting pressure (mm hg)(6 months after intervention)
- First sensation (volume of the balloon by cm water)(6 months after intervention)
- Intense urge (volume of the balloon by cm water)(6 months after intervention)
- First Urge(volume of the balloon by cm water)(6 months after intervention)
- Squeeze pressure (mm hg)(6 months after intervention)
- Resting pressure (mm hg)(3 months after intervention)
- Squeeze pressure (mm hg)(3 months after intervention)
- First sensation (volume of the balloon by cm water)(3 months after intervention)
- First Urge(volume of the balloon by cm water)(3 months after intervention)
- Intense urge (volume of the balloon by cm water)(3 months after intervention)
研究者
Olfat Ibrahim Ali
Assistant professor
Cairo University