A Randomized, Subject and Evaluator Blinded, Sham Controlled, Multicenter Study to Evaluate Efficacy and Safety of NASHA/Dx for the Treatment of Fecal Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 25
- 主要终点
- Percentage of Participants Who Are Responder50.
研究概览
简要总结
The purpose of this study is to determine the effectiveness and safety of NASHA/Dx when used as an injectable bulking agent in the treatment of fecal incontinence. The study includes a 6-month blinded sham-controlled phase, followed by an open-label phase.
详细描述
Subjects will be given up to 2 treatments of NASHA/Dx or sham and followed for 6 months from last treatment (ie, one retreatment is permitted at 1 month after the first injection) in the blinded phase of the study. At Month 6, the open phase of the study will begin and subjects on sham will be offered open-label treatment with NASHA/Dx.
Subjects who receive NASHA/Dx at the start of the blinded phase will be followed for up to 36 months from last treatment in the blinded phase. Subjects who receive sham at the start of the blinded phase and then receive open-label NASHA/Dx at Month 6 (start of the open phase) will be followed for another 24 months (equivalent to approximately 30 months from randomization) from last treatment in the open phase of the study.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age, male or female.
- •Screening fecal incontinence severity score (CCFIS).
- •Fecal incontinence episodes over a 14-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 (IBD).
- •Immunodeficiency or receiving immunosuppressive therapy.
- •Malignancies in remission for less than 2 years prior to the study.
- •Bleeding disorders or receiving anticoagulant therapy.
- •Chemotherapy within the last 12 months prior to the study.
- •Prior Pelvic radiotherapy.
- •Women who are pregnant or breast-feeding, or women of childbearing potential not practicing adequate contraception or planning to stop such contraception within the first year of the study.
- •Women within one year post partum.
- •Participation in any other clinical study within 3 month prior to the study.
- •Hypersensitivity to hyaluronic acid containing products.
- •Other severe conditions or in other ways unsuitable to participate according to investigator judgement.
结局指标
主要结局
Percentage of Participants Who Are Responder50.
时间窗: 6 months after last blinded treatment
Percentage of participants who achieve ≥ 50% reduction in the number of fecal incontinence episodes compared to baseline (Responder50).
Percentage of Participants Who Are Responder25.
时间窗: 12 months after last treatment
Response to treatment at 12 months was defined as a ≥ 25 % reduction in the number of fecal incontinence episodes compared to baseline (Responder25).
次要结局
- Number of Fecal Incontinence Episodes(up to 6 months after last treatment)
- Number of Incontinence Free Days(up to 6 months after last treatment)
- Change From Baseline in Fecal Incontinence Quality of Life Scale (FIQL).(up to 6 months after last treatment)
- Cleveland Clinic Florida Incontinence Score (CCFIS).(up to 6 months after last treatment)