Voro Urologic Scaffold for Urinary Incontinence (ARID II Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Levee Medical, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm. The study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.

Eligibility Criteria

Men aged 45+ diagnosed with prostate cancer, scheduled for radical prostatectomy, and willing to follow study procedures can join. They must not have severe urinary issues or other significant health problems that could interfere with the trial.

Inclusion Criteria

I have prostate cancer and am scheduled for complete prostate removal.

My prostate cancer is not highly aggressive.

My prostate is smaller than 80 grams.

I agree not to undergo any other SUI treatments during the study.

Exclusion Criteria

I have a brain or nerve condition that affects my ability to urinate.

I have severe heart failure (NYHA Class III or IV).

My diabetes is not under control (A1c >= 7.5%).

My overactive bladder score is more than 8.

My cancer has spread to the bladder neck or urethral sphincter.

I have had a narrowing of my urethra.

I have a history of urinary incontinence.

I have stress urinary incontinence.

I am currently taking medication for overactive bladder.

I have a narrowing in my urethra or bladder neck.

I have a current or ongoing urinary tract infection.

I have had surgery or a minimally invasive procedure for urinary problems.

I have had or will need radiation in the pelvic area after prostate surgery.

I have a history of bladder control issues due to nerve problems.

I have had bladder cancer in the past.

I use or have used a catheter for urination.

I have a condition or take medication that affects my immune system.

I am scheduled for surgery soon.

I had a specific prostate surgery that saved the front wall of my prostate.

I am scheduled for additional radiation therapy after my main treatment.

Participant Groups

The Voro Urologic Scaffold's safety and effectiveness are being tested in men undergoing robotic assisted radical prostatectomy compared to a control group in this randomized, controlled trial at multiple US centers.

2Treatment groups

Experimental Treatment

Active Control

Group I: Voro Urologic Scaffold GroupExperimental Treatment1 Intervention

Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. The Voro Urologic Scaffold will be placed during the prostatectomy procedure after prostate removal.

Group II: Control GroupActive Control1 Intervention

Participants will undergo robotic assisted radical prostatectomy procedure as part of their standard of care treatment for their prostate cancer. This group will not receive Voro Urologic Scaffold during the treatment.