Clinical trial NCT06351579: Data Collection Post Radical Prostatectomy
Official title: A Look at Outcomes After Post Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Stress Urinary Incontinence
Radical Prostatectomy
BPH
Keywords: SUI
BPH
Prostatectomy
Lead sponsor: Levee Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: RQMplus
First posted: 2024-04-08
Enrollment: 30
Sex: MALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The study is to collect information on patients undergoing radical prostatectomy (RP), with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.

Detailed description: Urinary incontinence is predominantly iatrogenic following radical prostatectomy (RP). Surgical removal of the prostate leads to a shortened urethra, widened bladder neck, and diminished urethral support. This results in increased demand on the urinary sphincter to maintain urinary continence. Most men will experience acute urinary incontinence following RP. Continence progressively improves over time; however, it is estimated that between 5-15% of men will experience chronic urinary incontinence.

Current treatments for post-prostatectomy urinary incontinence include conservative therapies such as pelvic floor muscle training and surgical treatments.

This study is to systematically collect detailed information on patients undergoing radical prostatectomy, with a primary focus on the occurrence, duration, and severity of post-prostatectomy incontinence. Data will be collected at multiple time points, allowing for a dynamic understanding of urinary incontinence patterns at post RP.

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

Primary outcomes:
measure: The change in average 24-hour pad weight over time
timeFrame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Secondary outcomes:
measure: Change in pad weight during a 1-hour provocative pad weight test
timeFrame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Other outcomes:
measure: Expanded Prostate Index Composite (EPIC-26) score.
timeFrame: Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.
Locations:
Study officials:
affiliation: Founder and CTO, Levee Medical, Inc
name: Bruce Choi
role: STUDY_CHAIR
References: