Pivotal Study of Voro Urologic Scaffold

About

Brief Summary

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

Male

Healthy Volunteers

No

Minimum Age

45 Years

Maximum Age

N/A

Inclusion Criteria:

Male >= 45 years of age of any race and ethnic group
Diagnosed with prostate cancer and scheduled for radical prostatectomy
Gleason Grade Group 4 or lower
Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)
Able and willing to provide written consent to participate in the study
Able and willing to comply with study follow-up visits and procedures
Willing to forego any other procedures for stress urinary incontinence (SUI) during the study

Exclusion Criteria:

Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example [e.g.,] Multiparametric magnetic resonance imaging [mpMRI], bone scan)
History of urinary incontinence, including stress or urge urinary incontinence
Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes
Currently treated with medications to treat overactive bladder (OAB)
Post void residual >200 milliliter (ml) or > 25 percentage (%) total volume(= voided volume + residual volume)
Presence of urethral stricture or bladder neck contracture
History of urethral stricture
Current or chronic urinary tract infection
Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate [TURP], Holmium laser enucleation of the prostate [HoLEP,] Rezum, etc.).
Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
History of neurogenic lower urinary tract dysfunction
History or current need for intermittent urinary catheterization
Body mass index >40

14. History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma)

History of bladder malignancy
Diagnosed or suspected primary neurologic conditions known to affect voiding function
History of clinically significant congestive heart failure (i.e., New York Heart Association [NYHA] Class III and IV)
Current uncontrolled diabetes (i.e., hemoglobin A1c [glycated hemoglobin or glycosylated hemoglobin] >=7.5%)
Current overactive bladder defined as a score of > 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit
History of immunosuppressive conditions or on medications which modulate the immune system
Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion
Participant with planned concomitant surgery
Anterior fascial sparing radical prostatectomy
Retzius sparing radical prostatectomy
Participant currently participating in other investigational studies unless approved by the Sponsor in writing
Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:
- Prisoners
- Individuals pending incarceration
- Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
Planned adjuvant radiation therapy