A Look at Outcomes After Post Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Levee Medical, Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The change in average 24-hour pad weight over time
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
The change in average 24-hour pad weight over time
Time Frame: 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.
Secondary Outcomes
- 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.)