Percutaneous tibial nerve stimulation of fecal incontinence: a multi center, randomized, placebo controlled study - PTNS in the treatment of FI

Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 32 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•- Written informed consent
•- Must be at least 18 years of age
•- Fecal incontinence with solid or liquid stool causing disruption of the subject*s lifestyle
•- Psychological stability as determined by the treating physician
•- Willingness to commit to a rigid follow-up schedule and comply with the investigational plan
•- Failed conservative therapy
•- During treatment the patient exhibits an adequate motor and/or sensory response (flexion of toe and/or twinkling sensation)
•- Is able to read and write

•- Major internal and/or external sphincter defect (defined as >33% of the anal circumference)
•- Fecal impaction
•- Pacemaker, implanted defibrillator
•- Pregnancy or intention to become pregnant
•- Neurogenic or congenital disorders resulting in FI
•- Inability to travel to the clinic twice a week

发起方

Medisch Universitair Ziekenhuis Maastricht