Treatment of Fecal Incontinence by Injection of Autologous Muscle Fibers Into the Anal Sphincter - a Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Efficacy of the treatment using fecal incontinence score: Wexner score.
研究概览
简要总结
Aim:
To investigate efficacy and safety in a new treatment with injection of autologous muscle fibers into the anal sphincter in patients with fecal incontinence.
Method:
Patients with fecal incontinence after obstetric anal sphincter rupture will be included. After inclusion, they will be offered 3 months of pelvic floor muscle training. If the patients after completion of pelvic floor muscle training still suffer from fecal incontinence, the patients will be offered treatment with autologous muscle fiber injection into the anal sphincter. The patients will be followed one year after the injection. The autologous muscle fibers are harvested at the patients leg muscle, cut into small pieces and injected into the anal sphincter. A small part of the fibers are used for analysing number of muscle stem cells and thereby the regenerative potential of the sample.
The study is a pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •fecal incontinence
- •Wexner score >= 9 or affected quality of life.
- •Understanding and speaking danish
- •Informed consent
排除标准
- •Ongoing pregnancy
- •Delivery in the last 12 months
- •colostomy
- •chronic inflammatory bowel disease (mb. crohn, colitis ulcerosa)
- •improvement after pelvic floor muscle training in an extent that makes autologous muscle fiber injection unnecessary.
研究组 & 干预措施
Injection of autologous muscle fibers in the anal sphincter
All patients, that still have relevant symptoms after completion of three months with individualized pelvic floor muscle training and dietary intervention to control defecatory function, will be offered injection of autologous muscle fiber fragments in the anal sphincter. A myscle biopsy will be taken from the leg, cut into small pieces in a saline solution and injected in the anal sphincter.
干预措施: Injection of autologous muscle fibers into the anal sphincter. (Procedure)
Injection of autologous muscle fibers in the anal sphincter
All patients, that still have relevant symptoms after completion of three months with individualized pelvic floor muscle training and dietary intervention to control defecatory function, will be offered injection of autologous muscle fiber fragments in the anal sphincter. A myscle biopsy will be taken from the leg, cut into small pieces in a saline solution and injected in the anal sphincter.
干预措施: Pelvic floor muscle training (Procedure)
Injection of autologous muscle fibers in the anal sphincter
All patients, that still have relevant symptoms after completion of three months with individualized pelvic floor muscle training and dietary intervention to control defecatory function, will be offered injection of autologous muscle fiber fragments in the anal sphincter. A myscle biopsy will be taken from the leg, cut into small pieces in a saline solution and injected in the anal sphincter.
干预措施: Dietary intervention (Behavioral)
Injection of autologous muscle fibers in the anal sphincter
All patients, that still have relevant symptoms after completion of three months with individualized pelvic floor muscle training and dietary intervention to control defecatory function, will be offered injection of autologous muscle fiber fragments in the anal sphincter. A myscle biopsy will be taken from the leg, cut into small pieces in a saline solution and injected in the anal sphincter.
干预措施: Analgesia (Drug)
结局指标
主要结局
Efficacy of the treatment using fecal incontinence score: Wexner score.
时间窗: 1 year
次要结局
- Safety(1 year)