Radical Prostatectomy, Stress Urinary Incontinence (SUI)
Conditions
Keywords
SUI, Radical Prostatectomy, Voro Urologic Scaffold, ARID II, Post-prostatectomy incontinence
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.
Interventions
DEVICEVoro Urologic Scaffold
The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal.
Sponsors
Levee Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
This is a multicenter, single blind, randomized controlled study.
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male \>= 45 years of age of any race and ethnic group 2. Diagnosed with prostate cancer and scheduled for radical prostatectomy 3. Gleason Grade Group 4 or lower 4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI) 5. Able and willing to provide written consent to participate in the study 6. Able and willing to comply with study follow-up visits and procedures 7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study
Exclusion criteria
1. 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) 2. History of urinary incontinence, including stress or urge urinary incontinence 3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes 4. Currently treated with medications to treat overactive bladder (OAB) 5. Post void residual \>200 milliliter (ml) or \> 25 percentage (%) total volume(= voided volume + residual volume) 6. Presence of urethral stricture or bladder neck contracture 7. History of urethral stricture 8. Current or chronic urinary tract infection 9. 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.). 10. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy 11. History of neurogenic lower urinary tract dysfunction 12. History or current need for intermittent urinary catheterization 13. 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) 15. History of bladder malignancy 16. Diagnosed or suspected primary neurologic conditions known to affect voiding function 17. History of clinically significant congestive heart failure (i.e., New York Heart Association \[NYHA\] Class III and IV) 18. Current uncontrolled diabetes (i.e., hemoglobin A1c \[glycated hemoglobin or glycosylated hemoglobin\] \>=7.5%) 19. Current overactive bladder defined as a score of \> 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit 20. History of immunosuppressive conditions or on medications which modulate the immune system 21. Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion 22. Participant with planned concomitant surgery 23. Anterior fascial sparing radical prostatectomy 24. Retzius sparing radical prostatectomy 25. Participant currently participating in other investigational studies unless approved by the Sponsor in writing 26. Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to: 1. Prisoners 2. Individuals pending incarceration 3. 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 27. Planned adjuvant radiation therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Severity | 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. |
| Number of participants achieving continence as measured by 1 hour provocative pad weight test at 6 weeks post-prostatectomy | At 6 weeks post-prostatectomy | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of incontinence as measured by 1 hour provocative pad weight test at 6 weeks | At 6 weeks | — |
| Severity of incontinence as measured by 1 hour provocative pad weight test at 6 months | At 6 months | — |
| Quality of Life (QoL) performance as assessed by the urinary domain of Expanded Prostate Cancer Index Composite (EPIC) Questionnaire | 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. |
| Continence rate as measured by 1-hour provocative pad weight test at 6 months post-prostatectomy | At 6 months post-prostatectomy | — |
| Number of participants achieving continence as measured by 1 hour provocative pad weight test at 12 months post-prostatectomy | At 12 months post-prostatectomy | — |
Countries
United States
Contacts
STUDY_DIRECTORKaren Cornett
Vice President, Levee Medical, Inc
Outcome results
None listed