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New scaffold aims to stop leakage after prostate surgery

NCT ID NCT06873581

Disease control Sponsor: Levee Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study tests a special scaffold placed during prostate removal surgery to help men regain bladder control. About 266 men will be randomly assigned to get the scaffold or standard care. The goal is to see if the scaffold reduces urine leakage and improves quality of life over two years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 266 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male \>= 45 years of age of any race and ethnic group 2. Diagnosed with prostate cancer and scheduled for radical prostatectomy 3. Gleason Grade Group 4 or lower 4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI) 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 7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study Exclusion Criteria: 1. Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example \[e.g.,\] Multiparametric magnetic resonance imaging \[mpMRI\], bone scan) 2. History of urinary incontinence, including stress or urge urinary incontinence 3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes 4. Currently treated with medications to treat overactive bladder (OAB) 5. Post void residual \>200 milliliter (ml) or \> 25 percentage (%) total volume(= voided volume + residual volume) 6. Presence of urethral stricture or bladder neck contracture 7. History of urethral stricture 8. Current or chronic urinary tract infection 9. Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate \[TURP\], Holmium laser enucleation of the prostate \[HoLEP,\] Rezum, etc.). 10. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy 11. History of neurogenic lower urinary tract dysfunction 12. History or current need for intermittent urinary catheterization 13. Body mass index \>40 14. History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma) 15. History of bladder malignancy 16. Diagnosed or suspected primary neurologic conditions known to affect voiding function 17. History of clinically significant congestive heart failure (i.e., New York Heart Association \[NYHA\] Class III and IV) 18. Current uncontrolled diabetes (i.e., hemoglobin A1c \[glycated hemoglobin or glycosylated hemoglobin\] \>=7.5%) 19. Current overactive bladder defined as a score of \> 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit 20. History of immunosuppressive conditions or on medications which modulate the immune system 21. Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion 22. Participant with planned concomitant surgery 23. Anterior fascial sparing radical prostatectomy 24. Retzius sparing radical prostatectomy 25. Participant currently participating in other investigational studies unless approved by the Sponsor in writing 26. Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to: 1. Prisoners 2. Individuals pending incarceration 3. Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires 27. Planned adjuvant radiation therapy

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Conditions

The condition(s) this trial relates to.

prostate cancer Urinary Incontinence, Stress female stress incontinence prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Radical prostatectomy Stress urinary incontinence (SUI)

Contacts and locations

Locations

  • Academic Urology

    Sun City, Arizona, 85351, United States

  • BMHCC/ Mississippi Urology Clinic

    Jackson, Mississippi, 39202, United States

  • Erlanger Urology

    Chattanooga, Tennessee, 37403, United States

  • IU school of Medicine, Department of Urology

    Indianapolis, Indiana, 46202, United States

  • John Hopkins

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic

    Phoenix, Arizona, 85054, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Northwell Health

    New Hyde Park, New York, 11042, United States

  • Potomac Urology Center

    Alexandria, Virginia, 22311, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138, United States

  • University of California Los Angeles

    Los Angeles, California, 90095, United States

  • University of California San Diego

    San Diego, California, 92093, United States

  • University of Chicago Medicine

    Chicago, Illinois, 60611, United States

  • University of Maryland

    Baltimore, Maryland, 21201, United States

  • University of Rochester Medical Center

    Rochester, New York, 14620, United States

  • Urology Associates PC Nashville

    Nashville, Tennessee, 37209, United States

  • Urology of Austin

    Austin, Texas, 78759, United States

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462, United States

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