Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351579
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Data Collection Post Radical Prostatectomy
Sponsor:
Levee Medical Inc
Organization:
Levee Medical Inc
Study Overview
Official Title:
A Look at Outcomes After Post Radical Prostatectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALTO
Brief Summary:
The study is 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 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
This 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
Current treatments for post-prostatectomy urinary incontinence include conservative therapies such as pelvic floor muscle training and surgical treatments
This 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None