A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 5
- 主要终点
- Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
研究概览
简要总结
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
详细描述
A prospective, multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject has agreed to be implanted with the AMS AdVance Male Sling System.
- •The subject is willing and able to give valid informed consent.
- •The subject is ≥40 years of age.
- •The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management and has less than 250 grams on the 24-hour pad weight test.
- •The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
- •Internal sphincter contractility confirmed by endoscopic view.
- •The subject's primary etiology is TUR, TURP, or radical prostatectomy.
- •Pre-existing urological conditions, other than incontinence have been treated and are under control.
- •The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
- •The subject is a good surgical candidate.
排除标准
- •The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- •The subject has a post-void residual ≥ 100 cc.
- •The subject has detrusor-external sphincter dyssynergia.
- •The subject has a urinary tract infection (UTI).
- •The subject was treated with pelvic radiation within the last 6 months.
- •The subject currently has an inflatable penile prosthesis.
- •The subject self-catheterizes.
- •The subject has symptomatic or unstable bladder neck structure disease.
- •The subject has a history of urethral strictures that may require repetitive instrumentation.
- •The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
- •The subject has a history of connective tissue or autoimmune conditions.
- •The subject has a compromised immune system.
- •The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
- •The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
研究组 & 干预措施
AMS AdVance Sling Group
European Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
干预措施: American Medical Systems (AMS) AdVance™ Male Sling System (Device)
结局指标
主要结局
Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
时间窗: 24 months
24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
时间窗: 24 months
1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Percentage of Subjects in Each Range of Pads Per Day Use
时间窗: 24 months
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
次要结局
- To Evaluate Patient Quality of Life(24 months)