Data Collection Post Radical Prostatectomy

Launched by LEVEE MEDICAL, INC. · Apr 2, 2024

Keywords

ClinConnect Summary

This clinical trial is studying men who are scheduled to undergo a surgery called radical prostatectomy (RP) to treat prostate cancer. The main goal is to gather information about urinary incontinence, which is the inability to control urination, that may occur after the surgery. Researchers want to understand how often this happens, how long it lasts, and how severe it can be. By collecting data at different times after the surgery, they hope to get a clearer picture of how urinary incontinence affects patients.

To be eligible for the study, participants need to be men aged 45 to 70 who have been diagnosed with prostate cancer and are set to have the surgery. They should have a specific type of cancer that is not too aggressive and a prostate that is not too large. Participants will need to agree to follow-up visits and provide consent to join the study. It’s important to note that individuals with certain medical conditions or histories, such as previous urinary incontinence or other serious health issues, will not be able to participate. If you join this trial, you can expect to answer questions about your urinary health at various points after your surgery to help improve understanding of post-surgery outcomes for future patients.

Gender

MALE

Eligibility criteria

• 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