NCT04088331已完成不适用
Artificial Urinary Sphincter Clinical Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 18
- 主要终点
- Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months
研究概览
简要总结
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
详细描述
Study is designed to evaluate the performance of the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age
- •Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
- •Demonstrates primary stress urinary incontinence
- •Positive screening 24-hour pad weight test (≥100 grams)
- •Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
- •Negative urine culture
- •Willing and able to undergo surgical implantation of the AUS device
- •Willing and able to comply with the follow-up requirements
- •Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
- •Willing and able to sign the informed consent
排除标准
- •Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
- •Primary urgency incontinence
- •Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
- •Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
- •Known urogenital malignancy other than previously treated prostate cancer
- •Recurrent prostate cancer that is expected to require intervention during the study follow-up period
- •History of recurrent bladder stones within the past 12 months prior to signing the informed consent
- •Neurogenic bladder
- •Need for intermittent catheterization
- •Known history of bleeding diathesis or coagulopathy
- •Immunosuppressed or on medical therapy which would impact the immune system
- •Uncontrolled diabetes, defined as (HbA1c>10)
- •Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
- •Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
- •Undergone bulking procedure within 6 months of the baseline assessment
- •Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
- •Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
- •Irresolvable detrusor hyperreflexia or bladder instability
- •Currently enrolled or plans to enroll in another device or drug clinical trial
- •Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
- •Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
- •Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)
研究组 & 干预措施
AMS 800 Artificial Urinary Sphincter Recipients
Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
干预措施: AMS 800 Artificial Urinary Sphincter (Device)
结局指标
主要结局
Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months
时间窗: 12 months
Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation
次要结局
- Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related(3 months, 6 months, and 12 months)
- Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation(Device Activation)
- Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation(Device Activation)
- Change in Number of Pads Per Day at 6 Months(6 months)
- Change in Number of Pads Per Day at 3 Months(3 months)
- Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months(6 months)
- Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months(6 months)
- Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months(12 months)
- Change in Number of Pads Per Day at 12 Months(12 months)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Early Activation of Artificial Urinary SphincterIncontinence, UrinaryNCT03962569CAMC Health System25
已完成
1 期
A New Therapeutic Strategy for Urethral Sphincter InsufficiencyUrethral Intrinsic Sphincter DeficiencyStress Urinary IncontinenceNCT00472069Assistance Publique - Hôpitaux de Paris10
招募中
4 期
Artificial Urinary Sphincter vs. Adjustable Male Sling for Treating male stress urinary INcontinenceN39.3Stress incontinenceDRKS00015253niversitätsmedizin Mainz270
进行中（未招募）
不适用
Safety and Efficacy Study of USTRAP™ in Male Urinary IncontinenceUrinary IncontinenceNCT03323554Quanta Medical20
已完成
不适用
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary IncontinenceStress Urinary IncontinenceNCT00998790Boston Scientific Corporation114