Data Collection Post Radical Prostatectomy (ALTO)

Levee Medical

Status: Completed

Conditions: BPH; Stress Urinary Incontinence; Radical Prostatectomy

Treatments: Other: Control

Study type: Observational

Funder types: Industry

Identifiers

NCT06351579

1010159

Details and patient eligibility

About

The study is designed 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.

Full description

Urinary incontinence (UI) 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. The sponsor is conducting a feasibility study (ARID) using a medical device to improve / reduce UI rate at post-RP. This study (ALTO) is designed as a control cohort to collect information on patients undergoing radical prostatectomy (RP) without using the device.

This ALTO 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.

Enrollment: 30 patients

Sex: Male

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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