Virtue® Male Incontinence Sling Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 21
- 主要终点
- Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
研究概览
简要总结
This study is a multi-center, global study that will assess the effectiveness and patient satisfaction of the male incontinence sling 12 months after implant as well as the safety profile of the product.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subject at least 18 yrs old with an estimated life expectancy of more than 5 years
- •Confirmed SUI (stress urinary incontinence) through medical history, urodynamics, and/or physical exam
- •Subject has completed urodynamics, uroflow, post-void residual and cystoscopy per protocol within 12 months prior to implant
- •Subject has intrinsic sphincter deficiency due to one of the following: post-TURP (trans-urethral resection of the prostate), simple open prostatectomy, radical prostatectomy completed at least 6 months prior to implantation date
- •Subject is willing to have the Virtue male sling implanted and is able and willing to completed all f/u visits and procedures as indicated in protocol
- •Subject agrees to the provisions of the study and has provided written informed consent as approved by the local ethics committee of the respective site
排除标准
- •Subject is unable or unwilling to sign the Informed Consent Form and/or comply with provisions of the study
- •Subject has active urogenital infection or active skin infection in region of surgery
- •Subject has serious bleeding disorders
- •Subject has incontinence due to neurogenic causes defined as multiple sclerosis, spinal cord/brain injury,CVA (cerebrovascular accident), detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions
- •Subject has previous implant to treat SUI
- •Subject has undergone radiation, cryosurgery, or brachytherapy to treat prostate or other pelvic cancer with 6 months or is likely to undergo radiation therapy within the next 6 months
- •Subject has active urethral or bladder neck stricture disease requiring continued treatment
- •Subject has urge predominant incontinence
结局指标
主要结局
Patient Satisfaction Using the Patient Global Impression of Improvement (PGI-I)
时间窗: 12 months post implant
Patient satisfaction using the Patient Global Impression of Improvement (PGI-I. Definition of Success: \>50% responding "very much better" or "much better".
Assess Change in 24-hour Pad Weight. Definition of Success: >50% With Outcome of Improved, Much Improved, Very Much Improved, or Cured (Dry).
时间窗: 12 months
Endpoint definition: Improved = 25-49% reduction of pad weight, Much Improved = 50-89% reduction of pad weight, Very Much Improved = \<12 grams or 90% reduction in pad weight, Cured = Dry. Definition of Success: \>50% responding "very much better" or "much better".
次要结局
- Assess Change in Subject Satisfaction Through ICIQ(12 months post implant)
- Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Bother(12 months post implant)
- Assess Change in Subject Satisfaction Through the UCLA-RAND Incontinence Index - Urinary Function(12 months post implant)
- Assess Change in Pad Use(12 months post-implant)
- Physician Questionnaire - Virtue® Surgical Procedure Was Straightforward(At implant)
- Physician Questionnaire - Virtue® Procedure Was as Easy as Competitive Therapies(At implant)
- Physician Questionnaire - Virtue® Was Easy to Position Over the Bulbous Urethra(At implant)