Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06275945
Other study ID # 1010073
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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.
See also
  Status Clinical Trial Phase
Recruiting NCT04829357 - Post Market Clinical Follow-up Study on TVT ABBREVO® Continence System
Completed NCT05493735 - Lidocaine for Pessary Check Pain Reduction Phase 3
Completed NCT04512053 - A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence Phase 2
Active, not recruiting NCT06224335 - Measurement of Intravaginal and Intra-abdominal Pressure and Pad Test During Sports Activities (SPORTVAGPRES)
Recruiting NCT05304312 - The Role of Kegel Exercises Book to Improve Treatment in Stress Urinary Incontinence Women N/A
Not yet recruiting NCT05527665 - Sexual Fonction and Discomfort in Women After Midurethral Sling Surgery, Using PPSSQ
Not yet recruiting NCT04558762 - Ten Years Follow-up After Insertion of a MUS (Mid Urethral Sling) Due to Stress Urinary Incontinence
Withdrawn NCT02524366 - A Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement N/A
Completed NCT01924728 - Efficacy of Magnetic Stimulation for Stress Urinary Incontinence N/A
Completed NCT01676662 - Solace European Confirmatory Trial N/A
Unknown status NCT01455779 - Lyrette: Renewing Continence Objective and Subjective Efficacy Study N/A
Terminated NCT01029106 - Gynecare TVT Secur for the Management of Stress Urinary Incontinence (SUI) N/A
Completed NCT01770691 - Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence N/A
Withdrawn NCT00573703 - Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence Phase 4
Completed NCT01123096 - Is the Cough Stress Test Equivalent to the 24 Hour Pad Test in the Assessment of Stress Incontinence? N/A
Completed NCT00234754 - Trans-Obturator Tape Versus Trans-Vaginal Tape for Stress Urinary Incontinence in Women N/A
Completed NCT00441454 - Retropubic vs. Transobturator Tension-free Vaginal Tape N/A
Completed NCT03985345 - Prospective Evaluation of the Connected EMY Biofeedback Probe in the Management of Stress Urinary Incontinence. N/A
Active, not recruiting NCT03671694 - Laser Vaginal Treatment for SUI N/A
Completed NCT04097288 - Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects Phase 1