An Open, Non-comparative, Post-marketing, Multi-center Study to Evaluate Efficacy and Safety of SolestaTM for the Treatment of Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 115
- 试验地点
- 15
- 主要终点
- Responder Rate in Number of Fecal Incontinence Episodes
研究概览
简要总结
The study will evaluate the safety and efficacy of Solesta as an injectable bulking agent in the treatment of fecal incontinence for a total of 24 months after completed 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age, male or female
- •Screening fecal incontinence severity score (CCFIS)
- •Fecal incontinence episodes over a 28-day period
- •Failed conservative treatment for fecal incontinence
排除标准
- •Complete external sphincter disruption
- •Significant anorectal disease
- •Anorectal surgery within the last 12 months prior to the study
- •Active Inflammatory Bowel Disease
- •Immunodeficiency or receiving immunosuppressive therapy
- •Malignancies in remission for less than 1 years prior to the study
- •Bleeding disorders or receiving anticoagulant therapy
- •Chemotherapy within the last 6 months prior to the study
- •Prior Pelvic radiotherapy
- •Pregnant or breast-feeding women, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study
- •Women within 6 months post partum
- •Participation in any other clinical study within 3 month prior to the study
- •Other severe conditions or in other ways unsuitable to participate according to investigator judgement
研究组 & 干预措施
Solesta
Open label. Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) The study treatment consisted of 4 submucosal injections, 1 mL Solesta each, in the proximal part of the high pressure zone in the anal canal.
Re-treatment is allowed one month after initial treatment if the subject is still incontinent.
干预措施: Solesta (Dextranomer in gel of stabilized non-animal hyaluronate) (Device)
结局指标
主要结局
Responder Rate in Number of Fecal Incontinence Episodes
时间窗: 12 months after last treatment compared to baseline
Responder rate in number of fecal incontinence episodes change from baseline at 12 month. Defined as responders at 12 month after treatment. A responder was defined as 50% or more reduction in the number of fecal incontinence episodes (28-day diary data)of solid or loose stool, compared to baseline.
次要结局
- Number of Fecal Incontinence Episodes.(at 12 month - change from baseline)
- Fecal Incontinence Severity Using the Cleveland Clinic Florida Incontinence Score(12 month - change from baseline)
- Fecal Incontinence Quality of Life (FIQL)(At 12 month - change from baseline)
- Number of Incontinence-free Days(At 12 month- change from baseline)