Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

NCT06275945 | Active Not Recruiting Phase 2

• 1 other identifier: 1010073
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence; Radical Prostatectomy

Keywords

SUI; Radical Prostatectomy

Outcome Measures

Primary Outcomes (1)

• The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.

  The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours.

  Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.

Secondary Outcomes (2)

• The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.

  Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.

• The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.

  Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.

Study Arms (1)

Voro Urologic Scaffold Group

EXPERIMENTAL

Subjects undergo radical prostatectomy procedure as part of their stand of care treatment for their prostate cancer. The Voro Urologic Scaffold is placed during the prostatectomy procedure after prostate removal. The device is placed over the urethral stump in its compressed configuration. With the device compressed at the pelvic floor, the urethral stump is anastomosed with the bladder neck. The device is expanded and positioned over the anastomosed urethra and bladder neck. The distal end of the device is sutured in place and the proximal end of the device is sutured to the bladder. The time of Voro Urologic Scaffold insertion and time of completion of device placement (i.e., final sutures placed) will be recorded. Incision closure will proceed per institution standard of care for the radical prostatectomy procedure.

Device: Voro Urologic Scaffold

Interventions

Voro Urologic Scaffold DEVICE

radical prostatectomy

Voro Urologic Scaffold Group

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 45-70 years of age
• Diagnosed with prostate cancer and scheduled for radical prostatectomy
• Gleason Grade Group 3 or lower
• Prostate size less than 80 grams
• Able and willing to provide written consent to participate in the study
• Able and willing to comply with study follow-up visits and procedures

You may not qualify if:

• Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
• History of urinary incontinence, including stress or urge urinary incontinence
• On medications to treat overactive bladder (OAB)
• Post void residual \>200 ml or \> 25% voiding volume
• Presence of urethral stricture or bladder neck contracture
• Current or chronic urinary tract infection
• Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
• Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
• Presence of stones in the bladder
• History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
• Body mass index \>35
• Insulin-dependent diabetes mellitus
• Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
• Intravesical prostatic protrusion (IPP) \>5mm
• History of immunosuppressive conditions (e.g., AIDS, post-transplant)

Sponsors & Collaborators

• Levee Medical, Inc.: lead
• RQM+: collaborator

Study Sites (1)

National Hospital

Panama City, Punta Pacifica, Panama

Location

Related Publications (1)

• Gahan JC, Espino G, Young M, Bodden E, Ferrandino MN. Initial results with an absorbable urologic scaffold to mitigate early urinary incontinence following radical prostatectomy: the ARID study. World J Urol. 2026 Jan 17;44(1):106. doi: 10.1007/s00345-026-06186-7.

  PMID: 41546699 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruce Choi

  Founder and CTO, Levee Medical, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized first-in-man study

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 23, 2024
• Study Start: April 3, 2023
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

PA (1)