Improving the Efficacy of Sacral Nerve Stimulation for Fecal Incontinence by Alteration of Stimulation Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Quality of life changes
研究概览
简要总结
Faecal incontinence is a devastating condition affecting 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated. Sacral nerve stimulation (SNS), has over the last decade given hope to patient failing conservative treatment. Some patient do not have optimal continence after SNS-therapy. This study aims to identify optimal stimulation parameters - that will improve the functional outcome of SNS-therapy thru a double blinded randomized cross-over study.
详细描述
Faecal incontinence is a devastating condition affecting daily living and has major influences on quality of life. Faecal incontinence affects 2,2 to 5 % of the adult population. The magnitude of the problem is probably underestimated, because most patients don't discuss this affliction with their general practitioner. A new treatment, SNS has over the last decade given new hope to these patients. But a group of these patients has minor effect of the treatment - despite a satisfactory test-stimulation period. This study aims to identify optimal stimulation parameters that will improve patient continence and quality of life. Four different stimulation parameters will be tested through a double blind, randomized crossover study - standard stimulation parameters (frequency: 14 Hz, pulse width 210 microsec.) will serve as control stimulation.
The study includes five arms that will be tested in a randomized order. Each arm will be tested for four weeks in which the patient fill in bowel habit diaries and standardized questionnaires. The first week in each period will not be evaluated - is serves as a wash-out period.
Before any pacemaker changes anorectal manometry and rectal filling tests will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Informed Consent
- •Diagnosed with idiopathic faecal incontinence,incontinence with minor (≤60 degrees) sphincteric defects or incontinence following sphincter repair.
- •Medtronic Interstim IPG(pacemaker)implanted for more than 6 months
- •minimum one incontinence episodes pr. week during ongoing SNS-therapy
排除标准
- •Colorectal surgery after IPG-implantation
- •Pregnancy or breastfeeding
- •Anal/perianal pain or discomfort
- •Patients who are not deemed able to follow the planned testing program, including mental illness or mentally unstable patients
- •Medication with known effects on gastrointestinal motility, thyroid disease, diabetes, coeliac, neurological disorders.
- •Spinal cord injury
- •Irritable Bowel Syndrome
结局指标
主要结局
Quality of life changes
时间窗: Will be assessed every four weeks during a twenty-week period
Quality of life will be recorded by means of Rockwood faecal incontinence quality of life score. A total of five evaluations will be made every fourth week in the twenty week protocol perioed.
次要结局
- Number of incontinence episodes(Will be assessed every four weeks durring a twenty-week period)
- Days with faecal soiling(Will be assessed every four weeks during a twenty-week period)
- Days with faecal urgency.(Will be assessed every four weeks during a twelve-week period)
- Wexner incontinence score(Will be assessed every four weeks during a twenty-week period)
- St. Marks Incontinence score(Will be assessed every four weeks during a twenty-week period)
- Assess changes in anorectal volume and pressure with different pacemaker settings(Will be assessed every four weeks during a twenty-week period)