BridgeMD
New treatment option for Radical Prostatectomy
Official title Pivotal Study of Voro Urologic Scaffold
ClinicalTrials.gov ID: NCT06873581
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older, men only
You may be able to join if
- 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
You likely can't join if
- Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example [e.g.,]...
- 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
See the full eligibility 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
- 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...
- Planned adjuvant radiation therapy
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Los Angeles, California, United States
- San Diego, California, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Jackson, Mississippi, United States
- New Hyde Park, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Chattanooga, Tennessee, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Alexandria, Virginia, United States
- Virginia Beach, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Sun City, Arizona, United States; Los Angeles, California, United States; San Diego, California, United States; Tampa, Florida, United States; Chicago, Illinois, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.