Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06873581

Pivotal Study of Voro Urologic Scaffold

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Radical Prostatectomy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Urinary Incontinence (SUI) Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

Voro Urologic Scaffold

Device

The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: 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.

  2. Number of Participants With Adverse Events Categorized by Severity

    Time frame: Upto 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.

  3. Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy

    Time frame: At 6 weeks post-prostatectomy

Secondary outcomes

  1. Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks

    Time frame: At 6 weeks

  2. Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months

    Time frame: At 6 months

  3. Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire

    Time frame: At 6 weeks, 6 months and 12 months

    The Expanded Prostate Cancer Index Composite is a validated, comprehensive questionnaire designed to evaluate patient function and bother after localized prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life.

  4. Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy

    Time frame: At 6 months post-prostatectomy

  5. Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy

    Time frame: At 12 months post-prostatectomy

Sponsors and collaborators

Lead sponsor

Levee Medical, Inc.

Industry

Registry information

Official study title

A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)

Acronym: ARID II

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.