| NCT ID | NCT03767595 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Uromedica |
| Condition | Stress Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 145 participants |
| Start Date | 2019-02-19 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 145 participants in total. It began in 2019-02-19 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.
Eligibility Criteria
Inclusion Criteria: 1. Subject is a male of at least 50 years of age. 2. Subject demonstrates stress urinary incontinence. 3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery. 4. Subject is willing and able to undergo surgical implantation of ProACT devices. 5. Subject is willing and able to comply with study-required follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and/or possible implantation of subsequent therapies. 6. Subject is willing and able to sign the approved informed consent. 7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests). 8. Subject has a negative urine culture. 9. Subject has no known urogenital malignancy, other than previously treated prostate cancer. 10. Subject meets ONE of the following criteria: 1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL; 2. Baseline PSA \> 2.5ng/mL and less than or equal to 10 ng/mL AND free PSA greater than or equal to 25% of total PSA; 11. Physician determines subject to be a suitable surgical candidate. Exclusion Criteria: 1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy. 2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months. 3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo. 4. Subject has undergone radiation therapy in the prostatic area within the last 12 months. 5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity. 6. Subject has an atonic bladder. 7. Subject had, presently has, or is suspected of having bladder cancer. 8. Subject has untreated or unsuccessfully treated bladder stones. 9. Subject has detrusor sphincter dyssynergia. 10. Subject has known hemophilia or a bleeding disorder. 11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest). 12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.
Contact & Investigator
Timothy C Cook, PhD
STUDY DIRECTOR
Uromedica, Inc.
Frequently Asked Questions
Who can join the NCT03767595 clinical trial?
This trial is open to male participants only, aged 50 Years or older, studying Stress Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03767595 currently recruiting?
Yes, NCT03767595 is actively recruiting participants. Contact the research team at pgora@uromedica-inc.com for enrollment information.
Where is the NCT03767595 trial being conducted?
This trial is being conducted at Denver, United States, Gainesville, United States, Atlanta, United States, Kansas City, United States and 2 additional locations.
Who is sponsoring the NCT03767595 clinical trial?
NCT03767595 is sponsored by Uromedica. The principal investigator is Timothy C Cook, PhD at Uromedica, Inc.. The trial plans to enroll 145 participants.