NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 主要终点
- Change in number of incontinence episodes
研究概览
简要总结
Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.
The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent FI (Miller incontinence score >5)
- •Anorectal malformation.
排除标准
- •Pregnancy
- •Rectal prolapse
- •Significant mucosal prolapse
- •Inflammatory bowel disease
- •Anorectal surgery within the last year Before inclusion
- •Anticoagulant medication/bleeding diathesis
- •Anorectal sepsis in the past
- •Immunodeficiency
- •Immunosuppressing therapy
研究组 & 干预措施
Treatment arm
Patients are given NASHA/Dx as a perianal injection
干预措施: NASHA/Dx (Solesta®) (Device)
结局指标
主要结局
Change in number of incontinence episodes
时间窗: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period.
次要结局
- Miller´s incontinence score(Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence).)
- Quality of life, general(Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated.)
- Adverse events(Before treatment compared with data at 18 months after treatment)
- Quality of life, disease specific(Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.)
研究者
Johan Danielson
Principal investigator
Uppsala University