CompletedNot Applicable

Data Collection Post Radical Prostatectomy

United States30 participantsStarted 2023-03-30

Plain-language 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.

Who can participate

Age range45 Years – 70 Years

SexMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

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.

Trial details

NCT IDNCT06351579

SponsorLevee Medical, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-30

View on ClinicalTrials.gov More Stress Urinary Incontinence trials