Clin2
NCT03767595Possibly a fitRecruiting

Study of ProACT implant for long-term urine leak control

Stress Urinary Incontinence

Part of Kidney & urinary, Women’s health & pregnancy clinical trials.

This study follows men who have urine leakage from stress (leakage with movement/coughing) after prostate surgery and receive a ProACT device. It looks at long-term outcomes over 5 years and checks safety, including for those who may need device removal or other treatments.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
145 people
Ages
50 years and older
Study type
Interventional

Who can take part

  • You are a man at least 50 years old.
  • You have stress urinary incontinence (urine leaks with activity or pressure).
  • You previously had prostate surgery (like radical prostatectomy or TURP).
  • You can and agree to have ProACT surgically implanted and do yearly phone follow-ups for 5 years, even if the device is removed or you get other treatments.
  • Your urine test is negative for infection, and you have specific proof of leakage on two 24-hour pad tests.
  • Your PSA blood test results and prostate cancer history fit the study rules, and your doctor feels you are a good surgical candidate.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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