NCT06351579

Data Collection Post Radical Prostatectomy

A Look at Outcomes After Post Radical Prostatectomy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Levee Medical, Inc. · Industry
• Sex: Male
• Age: 45 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence
• Radical Prostatectomy
• BPH

Interventions

Type	Name	Description
OTHER	Control	This is an observational (registry) study for data collection only. No device or intervention will be used in this study.

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2024-04-08
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States