Does Percutaneous Tibial Nerve Stimulation (PTNS) Improve Outcomes in Patients Presenting With Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Frequency of Fecal Incontinence
研究概览
简要总结
The primary objective of this study is to determine whether Percutaneous Tibial Nerve Stimulation (PTNS), a minimally invasive, simple, cost effective, and outpatient treatment of patients with urinary incontinence, can also be used to treat fecal incontinence. Specifically, the primary endpoint of this study is to determine, in a randomized controlled patient blinded study, whether PTNS decrease the episodes of fecal incontinence by 50% in the patients treated with PTNS when compared to placebo as documented by a 2 week patient bowel diary after treatment.
The investigators secondary endpoints will consist of measurements of the impact of PTNS on the severity of incontinence (defined as a decrease in the mean Fecal Incontinence Severity Index (FISI) score ), as well as on the patient quality of life factors related to fecal incontinence (defined as a decrease in the mean Fecal Incontinence Quality of Life (FIQoL) scale).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older
- •Able to provide informed consent
- •Has severe fecal incontinence (defined as weekly episodes of incontinence of mucus, liquid or solid stool)
- •Available to present for weekly treatments
- •Available for follow-up at 3, 6, and 12 months
排除标准
- •Severe cardiopulmonary disease
- •Lesion of the Tibial Nerve
- •Use of a cardiac pacemaker or implantable defibrillator
- •History of inflammatory bowel disease
- •Active anal fissure, fistula, or abscess
- •Active rectal bleeding which has not been evaluated with appropriate testing, such as colonoscopy
- •Has a sphincter injury that needs sphincteroplasty
- •Wants to pursue aggressive surgical therapy with a colostomy or an artificial bowel sphincter
- •Severe distal venous insufficiency
- •Uncontrolled diabetes with peripheral nerve involvement
- •Immunosuppression
- •Pregnant or planning on becoming pregnant during treatment
- •Patients prone to bleeding
研究组 & 干预措施
No active treatment
干预措施: Posterior tibial nerve stimulation (Device)
stimulation/treatment
干预措施: Posterior tibial nerve stimulation (PTNS) (Device)
结局指标
主要结局
Frequency of Fecal Incontinence
时间窗: Diary kept for 14 days following treatment
Patient kept 2 week bowel diary after completion of treatment. Bowel diary were collected to assess frequency of fecal incontinence in the two week span.
次要结局
- Change in Fecal Incontinence Severity Index (FISI) Score(12 weeks)
- Change in Fecal Incontinence Quality of Life (FIQoL) Score(12 weeks)
研究者
Liliana Bordeianou
Colorectal Surgeon, PI
Massachusetts General Hospital