A Look at Outcomes After Post Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The change in average 24-hour pad weight over time
研究概览
简要总结
The study is designed to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.
详细描述
Urinary incontinence (UI) is predominantly iatrogenic following radical prostatectomy (RP). Surgical removal of the prostate leads to a shortened urethra, widened bladder neck, and diminished urethral support. This results in increased demand on the urinary sphincter to maintain urinary continence. Most men will experience acute urinary incontinence following RP. Continence progressively improves over time; however, it is estimated that between 5-15% of men will experience chronic urinary incontinence.
Current treatments for post-prostatectomy urinary incontinence include conservative therapies such as pelvic floor muscle training and surgical treatments. The sponsor is conducting a feasibility study (ARID) using a medical device to improve / reduce UI rate at post-RP. This study (ALTO) is designed as a control cohort to collect information on patients undergoing radical prostatectomy (RP) without using the device.
This ALTO study is to systematically collect detailed information on patients undergoing radical prostatectomy, with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.
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
- 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)
- •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
- •History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete remission - a potential participant is considered cured if there has been no evidence of cancer within five years of enrollment
- •Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function
- •History of clinically significant congestive heart failure (i.e., New York Heart Association (NYHA) Class III and IV)
- •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
结局指标
主要结局
The change in average 24-hour pad weight over time
时间窗: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
The 24-hour (at-home) pad weight test - 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. The subject will be asked to change the pads approximately once every 6 hours during waking hours, or more frequently as needed. The pads will be stored in an air tight bag or container after removal, stored in a refrigerator, and brought to the site at the required follow-up visit for weighing.
次要结局
- Change in pad weight during a 1-hour provocative pad weight test(Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.)