Data Collection Post Radical Prostatectomy

NCT06351579 | Completed

• 1 other identifier: 1010159
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress Urinary Incontinence; Radical Prostatectomy; BPH

Keywords

SUI; BPH; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• The change in average 24-hour pad weight over time

  The 24-hour (at-home) pad weight test - The pads are pre-weighed prior to providing them to subjects. The test should be started with an empty bladder. The subject will wear pads and perform their normal daily activities for 24 hours. The subject will be asked to change the pads approximately once every 6 hours during waking hours, or more frequently as needed. The pads will be stored in an air tight bag or container after removal, stored in a refrigerator, and brought to the site at the required follow-up visit for weighing.

  Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.

Secondary Outcomes (1)

• Change in pad weight during a 1-hour provocative pad weight test

  Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.

Other Outcomes (1)

• Expanded Prostate Index Composite (EPIC-26) score.

  Baseline, post-foley, 6 weeks, 3 months, 6 months, and 12 months post-prostatectomy procedure.

Interventions

Control OTHER

This is an observational (registry) study for data collection only. No device or intervention will be used in this study.

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male 45-70 years of age
• Diagnosed with prostate cancer and scheduled for radical prostatectomy
• Gleason Grade Group 3 or lower
• Prostate size less than 80 grams
• Able and willing to provide written consent to participate in the study
• Able and willing to comply with study follow-up visits and procedures

You may not qualify if:

• Malignant tumors outside of the prostate capsule confirmed via baseline assessments (e.g., mpMRI, bone scan)
• History of urinary incontinence, including stress or urge urinary incontinence
• On medications to treat overactive bladder (OAB)
• Presence of urethral stricture or bladder neck contracture
• Current or chronic urinary tract infection
• Prior urologic outlet surgical or minimally invasive procedure (e.g., TURP, HoLEP, Rezum, etc.).
• Prior pelvic radiation or anticipated need for radiation after radical prostatectomy
• Presence of stones in the bladder
• History of neurogenic bladder, sphincter abnormalities, or poor detrusor muscle function
• Body mass index \>35
• 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
• History of clinically significant congestive heart failure (i.e., New York Heart Association (NYHA) Class III and IV)
• Insulin-dependent diabetes mellitus
• Current uncontrolled diabetes (i.e., hemoglobin A1c ≥7.5%)
• Intravesical prostatic protrusion (IPP) \>5mm

Sponsors & Collaborators

• Levee Medical, Inc.: lead
• RQM+: collaborator

Study Sites (1)

LeeveMedical, Inc

Durham, North Carolina, 27703, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bruce Choi

  Founder and CTO, Levee Medical, Inc

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: March 30, 2023
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)