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New study tracks bladder control after prostate surgery

NCT ID NCT06351579

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study followed 30 men aged 45-70 who had their prostate removed due to cancer. Researchers measured urine leakage by weighing pads over 24 hours and during a 1-hour activity test. The goal was to better understand how long and how severe incontinence lasts after surgery.

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.

Participants

30 people

The number who actually took part.

Started

Mar 2023

Finished

Jul 2025

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.

Who is studied

The study will enroll male subjects diagnosed with prostate cancer who are scheduled for radical prostatectomy. Subjects must meet all the inclusion criteria and none of the exclusion criteria to participate in the study.

Ages

45 to 70 years

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 45-70 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. Presence of urethral stricture or bladder neck contracture 5. Current or chronic urinary tract infection 6. Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.). 7. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy 8. Presence of stones in the bladder 9. History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function 10. Body mass index \>35 11. History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete remission - a potential participant is considered cured if there has been no evidence of cancer within five years of enrollment 12. Diagnosed or suspected primary neurologic conditions such as multiple sclerosis or Parkinson's disease or other neurological diseases known to affect bladder function, sphincter function or poor detrusor muscle function 13. History of clinically significant congestive heart failure (i.e., New York Heart Association (NYHA) Class III and IV) 14. Insulin-dependent diabetes mellitus 15. Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%) 16. Intravesical prostatic protrusion (IPP) \>5mm 17. History of immunosuppressive conditions (e.g., AIDS, post-transplant) 18. Any significant medical history that would pose an unreasonable risk or make the subject unsuitable for the study per investigator discretion 19. 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 20. Subject currently participating in other investigational studies unless approved by the Sponsor in writing

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • LeeveMedical, Inc

    Durham, North Carolina, 27703, United States

More trials for these conditions

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