ACTRN12616000056493已完成未知
Percutaneous posterior tibial nerve stimulation (PTNS) for treating faecal incontinence in females: A pilot study of combination treatment with biofeedback.
orthern Sydney Local Health District0 个研究点目标入组 13 人开始时间: 2016年1月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 13
研究概览
简要总结
This study shows that combining PTNS with biofeedback for the treatment of faecal incontinence in women is feasible, safe and well accepted by both patients and nurses. As this was a pilot study, conclusions regarding efficacy await larger studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- Female
入选标准
- •Patients who are referred to biofeedback treatment for faecal incontinence and satisfy the following will be offered participation:
- •2.Age >=18 and =<80
- •3. Faecal incontinence: defined as an uncontrolled passage of faecal material occurring at least 2-4 times a month, in the last 6 months.
- •4.Urge symptoms: defined as having an urge sensation before the uncontrolled passage in at least part of the FI episodes.
- •5.Failure of a trial of diet and bulking or laxative therapy in an effort to restore normal bowel movements.
- •6.Severity of FI: a minimal score of 8 on the FIS.
- •7.Willingness to give written informed consent and willingness to comply with the study.
排除标准
- •1.Presence of overt organic anorectal disorder - based on standard testing including physician assessment and imaging (anorectal ultrasound and/or colonoscopy).
- •2.Any general medical condition or medication that may compromise PTNS/BF treatment including:
- •a.Hypercoagulability state or anti-coagulation medication.
- •b.Latex allergy.
- •c.Implanted stimulator, pacemaker or defibrillator
- •d.Sciatica symptoms
- •e.Peripheral neuropathy
- •f.Peripheral vascular disease
- •3.Patients with a history of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.
- •4.Women lactating, pregnant or of childbearing potential who are not willing to avoid pregnancy during the study
- •5.Previous anorectal biofeedback training.
研究者
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