Feasibility Study of A VoRo UrologIc ScaffolD (ARID)

Stress Urinary Incontinence Clinical Trial

— ARID  

Official title:

Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06275945
• Other study ID #: 1010073
• Status: Recruiting
• Phase: Phase 2
• Start date: April 3, 2023
• Est. completion date: October 30, 2026

Study information

• Verified date: February 2024
• Source: Levee Medical, Inc.
• Contact: Yiming Deng
• Phone: 4083966040
• Email: dengyiming.mn[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 30, 2026
• Est. primary completion date: July 30, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Radical Prostatectomy
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Combination Product:
• Voro Urologic Scaffold
radical prostatectomy

Locations

Country	Name	City	State
Panama	National Hospital	Panama City	Punta Pacifica

Sponsors (2)

Lead Sponsor	Collaborator
Levee Medical, Inc.	RQMplus

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.	The 1-hour pad test follows a standard protocol. Prior to the 1-hour test, the subject is asked to ensure he is adequately hydrated. This will be determined by the color of the urine during the voiding prior to the start of the test. The urine must be clear or light yellow in color to start the test. If the urine is dark yellow, the subject should be given fluids to drink until the urine is light yellow or close to colorless (proper hydration).; If voiding is urgent and unavoidable, the test is terminated. Collect voiding volume and repeat the test after re-hydration.	Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
Secondary	The changes in the standing cough test (SCT) from baseline to post procedure 6-month and 12-month follow-ups.	The subject must verbally confirm that they have not voided for at least 60 minutes prior to the examination. Examination of the urethral meatus is performed while the subject performs four forceful coughs. Towels or pads are held several inches from the meatus during coughs to collect any urinary leakage. Leakage is evaluated using the Male Stress Incontinence Grading Scale (MSIGS).	Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.