Voro Urologic Scaffold for Stress Urinary Incontinence After Prostatectomy
This study is testing a device called the Voro Urologic Scaffold. It's designed to help men who experience stress urinary incontinence (SUI), which is leaking urine when you cough, sneeze, or laugh, after having their prostate removed (radical prostatectomy). The scaffold is placed during the prostate removal surgery. Researchers want to see how safe and effective the Voro Urologic Scaffold is compared to standard care. You might be able to join if you are a man at least 45 years old, have prostate cancer, and are scheduled for a radical prostatectomy. The study will measure how many participants have side effects and how many achieve continence (no urine leakage) after surgery. The current recruitment status is unclear.
- Study design
- This is a multi-center, single-blind, randomized, controlled study involving up to 266 participants across 30 centers in the United States.
- What's involved
- You would have a baseline visit, the scaffold implanted during surgery, catheter removal, and follow-up visits at 6 weeks, 6 months, 12 months, 18 months, and 24 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 24 months after the procedure to monitor for adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pivotal Study of Voro Urologic Scaffold
At a glance
Conditions
Where it's being run
19 sites across 11 statesStudy leadership
- Karen Cornett · STUDY_DIRECTOR · Vice President, Levee Medical, Inc
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Number of participants with adverse events (AEs)Upto 24 months
AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants during the course of the study, whether or not related to the investigational device.
- Number of Participants With Adverse Events Categorized by SeverityUpto 24 months
The severity of adverse events as assessed by the investigator; events will be based on the definitions outlined in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
- Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomyAt 6 weeks post-prostatectomy