An Investigation of the Treatment of Fecal Incontinence Using the TOPAS Sling System For Women (TRANSFORM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 28
- 主要终点
- Percentage of Responders
研究概览
简要总结
The purpose of this study is to demonstrate that the TOPAS System effectively treats fecal incontinence in women as measured by a 50% reduction in the number of FI episodes in a 14 day bowel diary at 12 months.
详细描述
This is a prospective, multi-center, single-arm, open-label, two- stage, adaptive study conducted to obtain data to demonstrate the safety and effectiveness of the TOPAS system for the treatment of FI in women who have failed conservative therapy. It was approved by the FDA for up to 152 implanted subjects at up to 15 investigational sites in the US. Eight study centers are led by a Colorectal Surgeon and seven centers are led by an Urogynecologist.
This study is being conducted in compliance with Title 21 CFR Parts 11, 50, 54, 56, and 812; the principles of GCP as set forth in the World Medical Association Declaration of Helsinki (2008); and the ISO standard 14155:2011 (Clinical investigation of medical devices for human subjects - Good clinical practice).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is/has:
- •An adult (>/= 18 years) female.
- •FI symptoms for a minimum of 6 months.
- •Failed two modalities of conservative therapies such as Dietary Modification, Pharmacologic Intervention, or Pelvic Floor Muscle Training.
- •<50 years old OR if >/= 50 years old, has had a negative cancer screening examination of the colon according screening guidelines (colonoscopy or barium enema + flexible sigmoidoscopy) within the past 3 years prior to informed consent date. (Note: if not done, the investigating physician must provide written justification for not having this exam and must be following the American Cancer Society Guidelines).
- •FI episodes ≥ 4 in 14 day period.
排除标准
- •Subject is/has
- •Unable or unwilling to sign Informed Consent Form or comply with study requirements.
- •Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by AMS.
- •Allergic to polypropylene.
- •Pregnant or planning a future pregnancy.
- •Less than 12 months (365 days) postpartum.
- •Pelvic prolapse >/=1 cm beyond the hymen (Stage III & IV)
- •Had stress urinary incontinence (SUI) or anterior repair within 3 months (90 days) prior to TOPAS Sling System implantation.
- •Had a hysterectomy, Sphincteroplasty, or Posterior surgery within 6 months (180 days) prior to TOPAS Sling System implantation.
- •Had rectal surgery (such as rectopexy) within 12 months (365 days) of TOPAS Sling System implantation.
- •Planning pelvic surgery within 12 months (365 days) post implant
- •Current Grade III or IV hemorrhoids.
- •Neurological or psychological condition as cause of FI such as MS, dementia, brain tumor.
- •Diagnosed Inflammatory Bowel Disease (for example, ulcerative colitis or Crohn's disease).
- •Chronic, watery diarrhea, unmanageable by drugs or diet, as primary cause of fecal incontinence.
- •Severe chronic constipation, including obstructive defecatory disorder.
- •External full thickness rectal prolapse.
- •A history of laxative abuse within the past 5 years.
- •Had previous rectal resection.
- •Active pelvic infection, perianal or recto-vaginal fistula.
- •Congenital anorectal malformations or chronic 4th degree lacerations and cloacae.
- •History of therapeutic radiation for cancers of the pelvis.
- •Currently implanted with a sacral nerve stimulator.
- •Contraindicated for surgery or having any condition that would compromise wound healing.
结局指标
主要结局
Percentage of Responders
时间窗: 12 Months
The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
次要结局
- Change in Urge Fecal Incontinence Episodes(36 Month Follow-up Visit)
- Change in Fecal Incontinence Days(36 Month Follow-up Visit)
- Change in Wexner Symptom Severity Score(36 Month Follow-up Visit)
- Change in Fecal Incontinence Quality of Life Score(36 Month Follow-up Visit)
- Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores(36 Month Follow-up Visit)
- Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)(36 Month Follow-up Visit)
- Change in Fecal Incontinence Episodes(36 Month Follow-up Visit)
- Change in Pelvic Floor Distress Inventory (PFDI-20) Scores(36 Month Follow-up Visit)
- Change in Numeric Pelvic Pain Scale (NPPS)(12 Month Follow-up Visit)