A Pivotal Study of Voro Urologic Scaffold for the Treatment of PostProstatectomy Stress Urinary Incontinence

Research Study of an Investigational Device for Stress Urinary Incontinence After Prostate Surgery

M
Michael Koch, MD

Primary Investigator

Enrolling By Invitation
45 years - 100 years
Male
Phase N/A
53 participants needed
1 Location

Brief description of study

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.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Radical Prostatectomy, Stress Urinary Incontinence, SUI
  • Age: 45 years - 100 years
  • Gender: Male

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
  5. Negative urine cultures within 30 days of the procedure
  6. Able and willing to provide written consent to participate in the study
  7. Able and willing to comply with study follow-up visits and procedures
  8. 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 (%) voiding 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
  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

Updated on 30 Jun 2025. Study ID: UROL-LEVEE-ARID-II, 26975

This study investigates the use of an investigational device for men who have stress urinary incontinence after having their prostate removed because of cancer. Stress urinary incontinence happens when activities like coughing or lifting cause urine to leak. The purpose of this study is to see if the device is safe and works well compared to not using the device.

Participants will have a device placed during their prostate surgery. The study is single blind, meaning participants do not know if they have the device or are in the control group. There will be follow-up visits to check on the device and the participants' condition.

  • Who can participate: Men aged 45 and older who have been diagnosed with prostate cancer and are scheduled for prostate removal surgery may be eligible. Participants must have a prostate size of less than 80 grams, negative urine cultures, no history of urinary incontinence, and must be willing to forego other SUI procedures.
  • Study details: Participants will have a device implanted during their prostate removal surgery. The study involves a control group receiving a placebo, which is an inactive substance that looks like the investigational device but does not contain any medicine.
  • Study timelines and visits: The study will last 24 months. The study requires 8 visits.
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only