A Pre-Market Study of the AMS Transobturator 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
- 55
- 试验地点
- 22
- 主要终点
- Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
研究概览
简要总结
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.
详细描述
A 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 Questionnaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the International Consultation on Incontinence Questionnaire (ICIQ)) 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 Male Transobturator 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.
- •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, radical prostatectomy, open prostatectomy, or suprapubic 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 an atonic bladder.
- •The subject has a post-void residual > 75 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 stricture 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.
结局指标
主要结局
Procedural Endpoint: Rate of Foley Catheter Use - Post-operative
时间窗: post-operative to discharge
Number of participants requiring the use of a foley catheter who were able to void prior to discharge.
Procedural Endpoint: Rate of Foley Catheter Use - Post-discharge
时间窗: post discharge
Number of participants requiring the use of a foley catheter post-discharge following Bladder Management instructions.
Procedural Endpoint: Descriptive Procedural Parameters - Movement of Urethral Bulb While Tensioning
时间窗: During Procedure, Approximately 60 Minutes
Characterize procedural parameters, including the movement of urethral bulb while tensioning in all participants.
Procedural Endpoint: Procedure Time From First Incision to Closing.
时间窗: During Procedure, Approximately 60 Minutes
Characterize procedure time from first incision to closing.
Procedural Endpoint: Descriptive Procedural Parameters - Use of Tack Sutures
时间窗: During Procedure, Approximately 60 Minutes
Characterize procedural parameters including the use of tack sutures.
Device Success as Defined as Successful Placement of the Device in Desired Position Peri-operatively
时间窗: During Procedure, Approximately 60 Minutes
Summarize device success as defined as a successful placement of the device in a desired position, peri-operatively, in participants.
Procedural Endpoint: Rate of Foley Catheter Use - Intraoperative
时间窗: During Procedure, Approximately 60 Minutes
Number of participants requiring the use of a foley catheter intra-operatively.
Procedural Endpoint: Descriptive Procedural Parameters - Muscle Dissection
时间窗: During Procedure, Approximately 60 Minutes
Characterize procedural parameters, including muscle dissection across all participants.
Procedural Endpoint: Type of Anesthesia Used
时间窗: During Procedure, Approximately 60 Minutes
Describe the type of anesthesia used.
次要结局
- Subject Satisfaction Endpoint: 24-Hour Pad Weight(Baseline to 24 month)
- Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (1 Hour Pad Weight Test)(Baseline to 24 month)
- Subject Satisfaction Endpoint: Pads Per Day Use(Baseline to 24 Months)
- Subject Satisfaction Endpoint: Physician Evaluation of Subject's Incontinence Status(6 Weeks post implant to 24 Months)
- Procedural and Device Complication Rates(Procedure to 24 Months Post implant)
- Subject Satisfaction Endpoint: 1-Hour Pad Weight(Baseline to 24 month)
- Subject Satisfaction Endpoint: Percentage of Subjects Having a Decrease of Pad Weight of 25%, 50%, or 75% at Follow-Up. (24 Hour Pad Weight Test)(Baseline to 24 Month)
- Subject Satisfaction Endpoint: Quality of Life I-QOL Scores(Baseline to 24 Months)
- Subject Satisfaction Endpoint: Quality of Life International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) Scores(Baseline to 24 Months)
- Subject Satisfaction Endpoint: Quality of Life UCLA (University of California Los Angeles) / RAND (RAND Corporation) Scores(Baseline to 24 Months)