A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
- 试验地点
- 43
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.
The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male >= 45 years of age of any race and ethnic group
- •Diagnosed with prostate cancer and scheduled for radical prostatectomy
- •Gleason Grade Group 4 or lower
- •Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
- •Able and willing to provide written consent to participate in the study
- •Able and willing to comply with study follow-up visits and procedures
- •Willing to forego any other procedures for stress urinary incontinence (SUI) during the study
排除标准
- •Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example [e.g.,] Multiparametric magnetic resonance imaging [mpMRI], bone scan)
- •History of urinary incontinence, including stress or urge urinary incontinence
- •Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
- •Currently treated with medications to treat overactive bladder (OAB)
- •Post void residual >200 milliliter (ml) or > 25 percentage (%) total volume(= voided volume + residual volume)
- •Presence of urethral stricture or bladder neck contracture
- •History of urethral stricture
- •Current or chronic urinary tract infection
- •Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate [TURP], Holmium laser enucleation of the prostate [HoLEP,] Rezum, etc.).
- •Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
- •History of neurogenic lower urinary tract dysfunction
- •History or current need for intermittent urinary catheterization
- •Body mass index >40
- •History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma)
- •History of bladder malignancy
- •Diagnosed or suspected primary neurologic conditions known to affect voiding function
- •History of clinically significant congestive heart failure (i.e., New York Heart Association [NYHA] Class III and IV)
- •Current uncontrolled diabetes (i.e., hemoglobin A1c [glycated hemoglobin or glycosylated hemoglobin] >=7.5%)
- •Current overactive bladder defined as a score of > 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit
- •History of immunosuppressive conditions or on medications which modulate the immune system
- •Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion
- •Participant with planned concomitant surgery
- •Anterior fascial sparing radical prostatectomy
- •Retzius sparing radical prostatectomy
- •Participant currently participating in other investigational studies unless approved by the Sponsor in writing
- •Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:
- •Individuals pending incarceration
- •Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
- •Planned adjuvant radiation therapy
研究组 & 干预措施
Voro Urologic Scaffold Group
Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. The Voro Urologic Scaffold will be placed during the prostatectomy procedure after prostate removal.
干预措施: Voro Urologic Scaffold (Device)
Control Group
Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. This group will not receive Voro Urologic Scaffold during the treatment.
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Upto 24 months
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
Number of Participants With Adverse Events Categorized by Severity
时间窗: Upto 24 months
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy
时间窗: At 6 weeks post-prostatectomy
次要结局
- Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy(At 12 months post-prostatectomy)
- Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks(At 6 weeks)
- Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months(At 6 months)
- Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire(At 6 weeks, 6 months and 12 months)
- Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy(At 6 months post-prostatectomy)
- Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks(At 6 weeks)
- Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months(At 6 months)
- Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire(At 6 weeks, 6 months and 12 months)
- Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy(At 6 months post-prostatectomy)
- Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy(At 12 months post-prostatectomy)