Clinical trial NCT06275945: Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
Official title: Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stress Urinary Incontinence
Radical Prostatectomy
Keywords: SUI
Radical Prostatectomy
Lead sponsor: Levee Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: RQMplus
First posted: 2024-02-23
Enrollment: 40
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized first-in-man study
Primary purpose: PREVENTION

Brief summary: The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.

Detailed description: Approximately 300,000 men undergo radical prostatectomy (RP) worldwide for the treatment of prostate cancer. RP has favorable oncology outcomes but carries risks of erectile dysfunction and urinary incontinence. Urinary incontinence after RP has negatively affects patient quality of life.

The bioresorbable Voro Urologic Scaffold is designed to be placed over the anastomotic site during an RP procedure, between the bladder neck and urethral stump, to constrain the urethra immediately proximal to the urinary sphincter. The device is designed to relieve the load on the urinary sphincter. As the anastomosis heals, connective tissues form in the scaffold geometry while the scaffold material resorbs and hence potentially reduce the risk of acute and chronic stress incontinence.

The objective of this study is to evaluate the safety and performance of the Voro Urologic Scaffold as a prophylactic treatment for post-prostatectomy stress urinary incontinence.

The study is a prospective, multicenter, single arm study. Up to 40 subjects will be treated at up to 3 investigational sites in Panama. Subjects will be followed up post-treatment at catheter removal, 6 weeks post prostatectomy, 3 months, 6 months, 12 months and 2 years.

Eligibility criteria: Inclusion Criteria:

1. Male 45-70 years of age
2. Diagnosed with prostate cancer and scheduled for radical prostatectomy
3. Gleason Grade Group 3 or lower
4. Prostate size less than 80 grams
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

Exclusion Criteria:

1. Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
2. History of urinary incontinence, including stress or urge urinary incontinence
3. On medications to treat overactive bladder (OAB)
4. Post void residual \>200 ml or \> 25% voiding volume
5. Presence of urethral stricture or bladder neck contracture
6. Current or chronic urinary tract infection
7. Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
8. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
9. Presence of stones in the bladder
10. History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
11. Body mass index \>35
12. Insulin-dependent diabetes mellitus
13. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
14. Intravesical prostatic protrusion (IPP) \>5mm
15. History of immunosuppressive conditions (e.g., AIDS, post-transplant)
16. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion
17. Any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affect the ability to complete the study quality of life questionnaires
18. Subject currently participating in other investigational studies unless approved by the Sponsor in writing

Primary outcomes:
measure: The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
timeFrame: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.
Secondary outcomes:
measure: The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
timeFrame: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
measure: The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.
timeFrame: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
Other outcomes:
Locations:
city: Panama City
country: Panama
facility: National Hospital
state: Punta Pacifica
Study officials:
affiliation: Founder and CTO, Levee Medical, Inc
name: Bruce Choi
role: STUDY_CHAIR
References: