Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
研究概览
简要总结
The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.
详细描述
Approximately 300,000 men undergo radical prostatectomy (RP) worldwide for the treatment of prostate cancer. RP has favorable oncology outcomes but carries risks of erectile dysfunction and urinary incontinence. Urinary incontinence after RP has negatively affects patient quality of life.
The bioresorbable Voro Urologic Scaffold is designed to be placed over the anastomotic site during an RP procedure, between the bladder neck and urethral stump, to constrain the urethra immediately proximal to the urinary sphincter. The device is designed to relieve the load on the urinary sphincter. As the anastomosis heals, connective tissues form in the scaffold geometry while the scaffold material resorbs and hence potentially reduce the risk of acute and chronic stress incontinence.
The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.
The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male 45-70 years of age
- •Diagnosed with prostate cancer and scheduled for radical prostatectomy
- •Gleason Grade Group 3 or lower
- •Prostate size less than 80 grams
- •Able and willing to provide written consent to participate in the study
- •Able and willing to comply with study follow-up visits and procedures
排除标准
- •Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
- •History of urinary incontinence, including stress or urge urinary incontinence
- •On medications to treat overactive bladder (OAB)
- •Post void residual >200 ml or > 25% voiding volume
- •Presence of urethral stricture or bladder neck contracture
- •Current or chronic urinary tract infection
- •Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
- •Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
- •Presence of stones in the bladder
- •History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
- •Body mass index >35
- •Insulin-dependent diabetes mellitus
- •Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
- •Intravesical prostatic protrusion (IPP) >5mm
- •History of immunosuppressive conditions (e.g., AIDS, post-transplant)
- •Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion
- •Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
- •Subject currently participating in other investigational studies unless approved by the Sponsor in writing
研究组 & 干预措施
Voro Urologic Scaffold Group
Subjects undergo radical prostatectomy procedure as part of their stand of care treatment for their prostate cancer. The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal. The device is placed over the urethral stump in its compressed configuration. With the device compressed at the pelvic floor, the urethral stump is anastomosed with the bladder neck. The device is expanded and positioned over the anastomosed urethra and bladder neck. The distal end of the device is sutured in place and the proximal end of the device is sutured to the bladder.
The time of Voro Urologic Scaffold insertion and time of completion of device placement (i.e., final sutures placed) will be recorded.
Incision closure will proceed per institution standard of care for the radical prostatectomy procedure.
干预措施: Voro Urologic Scaffold (Device)
结局指标
主要结局
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
时间窗: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.
The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours.
次要结局
- The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.(Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.)
- The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.(Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.)