NCT00565136已完成1 期
Evaluation of the Outcomes of Restoring Pelvic Floor Support Using TOPAS, AMS Pelvic Floor Support System, in Women With Moderate Fecal Incontinence Symptoms
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 10
- 主要终点
- Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
研究概览
简要总结
The study purpose is to gain experience with the TOPAS system, a minimally- invasively delivered self-fixating mesh for the treatment of pelvic floor weakness in women with symptoms of moderate fecal incontinence
详细描述
This is a multi-center study under a common protocol. Approximately 20-30 patients will be enrolled across 5 sites in the U.S. The study population is females at least 21 years of age who have attempted but have not been satisfied with conservative therapy for their fecal incontinence symptoms. The study follow-up is two years.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females at least 21 years of age who have evidence of pelvic floor weakness
- •Females who attempted but not been satisfied with conservative therapies such as dietary changes, dietary bulking agents, biofeedback, etc.
- •Subjects, who have an external anal injury, must have some voluntary sphincter control
排除标准
- •Subjects who are unwilling or unable to sign an Informed Consent form
- •Subjects who are currently pregnant or considering future child-bearing
- •Subjects who are contraindicated for surgery
- •Subjects who are allergic to polypropylene mesh
- •Subjects who are enrolled in a concurrent clinical trial
- •Subjects with previous implantation of mesh or trauma to the pelvic area
- •Subjects who engage in anal receptive intercourse
- •Subjects with a significant evacuation disorder such as chronic constipation
- •Subjects with Crohn's Disease, ulcerative colitis or chronic diarrhea as the primary cause for fecal incontinence
- •Subjects who had a hysterectomy within 6 months prior to enrollment
- •Subjects with vaginal prolapse that passes the hymen
- •Subjects with complete rectal prolapse
- •Subjects with a history of pelvic radiation that compromises the anal canal
- •Subjects who have psychiatric disturbance or debilitation as a possible cause for fecal incontinence
- •Subjects with a neurological disorder such as amyotrophic lateral sclerosis, multiple sclerosis, or brain tumor as a possible cause for fecal incontinence symptoms
- •Subjects with an active pelvic infection or a recto-vaginal fistula
- •Subjects who have not had a negative screening exam for colon cancer within 10 years of enrollment
- •Subjects who have other inappropriate conditions as determined by the physician
结局指标
主要结局
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
时间窗: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.
次要结局
- Intra- and Peri-Surgical Parameters: Length of Procedure(Duration of the device implant procedure)
- Fecal Incontinence Symptoms as Measured by the Wexner Score(Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment)
- Intra- and Peri-Surgical Parameters: Length of Hospital Stay(Length of the hospital stay for the device implant procedure)
- Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure(Duration of the device implant procedure (an average of 23 minutes))
- Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period(Through 24 month post-treatment)
- Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence(Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment)
- Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life(Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatment)
- Pain Intensity as Measured by the Pain Intensity Scale(Baseline (pre-treatment), 6 Week post-treatment)
研究者
研究点 (10)
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