Stress Urinary IncontinencePhase 2ARIDNCT06275945
Feasibility Study of A VoRo UrologIc ScaffolD (ARID)
A Phase 2 study testing Voro Urologic Scaffold in people with Stress Urinary Incontinence and Radical Prostatectomy, run by Levee Medical, Inc. at 1 site in Panama.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men only
- Conditions the study is for
- Stress Urinary Incontinence, Radical Prostatectomy
- What is being tested?
- Voro Urologic Scaffold
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePanama
- Study dates
- 3 Apr 2023to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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)
- Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion
- 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
- Subject currently participating in other investigational studies unless approved by the Sponsor in writing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary 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.
Read the 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.
- Conditions
- Stress Urinary Incontinence, Radical Prostatectomy
- Being tested
- Voro Urologic Scaffold
- Keywords
- SUI, Radical Prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voro Urologic ScaffoldDevice
radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Voro Urologic Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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).
Measured: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 Apr 2023
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized first-in-man study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Levee Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Responsible party
- Sponsor
- Investigators
- Bruce Choi, Study chair, Founder and CTO, Levee Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275945
- Sponsor's protocol ID
- 1010073
- Acronym
- ARID
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41546699
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of A VoRo UrologIc ScaffolD for the Prophylactic Treatment of Post-Prostatectomy Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06275945
- Acronym / sponsor ID
- ARID / 1010073
- Conditions
- Stress Urinary Incontinence, Radical Prostatectomy
- Keywords
- SUI, Radical Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Levee Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- RQM+
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized first-in-man study
| Arm | Type | Receives |
|---|---|---|
| Voro Urologic Scaffold Group | Experimental | Device: Voro Urologic ScaffoldSubjects 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voro Urologic Scaffoldradical prostatectomy | Device | Voro Urologic Scaffold Group |
Primary outcome
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
Time frame: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months 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.
2 secondary outcomes
The change in pad weight of 1-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups.
Time frame: 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.
Time frame: Baseline, post-procedure 6-week, and 3-, 6-, 12- & 24-months follow-ups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Derived from this study: PubMed 41546699Gahan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce Choi study chair
Founder and CTO, Levee Medical, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Voro Urologic Scaffold in people with Stress Urinary Incontinence and Radical Prostatectomy, run by Levee Medical, Inc. at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in pad weight of 24-hour pad weight test from baseline to post procedure 6-month and 12-month follow-ups. (time frame: Baseline, Foley removal (about 2-week post procedure), 6-week, and 3-, 6-, 12- & 24-months follow-ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.