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ProACT Post-Approval Study | Clinical Trials | Clareo Health

RECRUITINGNA

ProACT Post-Approval Study

Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men

NCT03767595•Uromedica

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

Age

50 - No limit years

Sex

MALE

Healthy Volunteers

Yes

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.
+4 more criteria

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.
+2 more criteria

Locations (6)

University of Colorado

Denver, Colorado, United States

University of Florida

Gainesville, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

University of Michigan

Ann Arbor, Michigan, United States

CentraCare- St. Cloud

Saint Cloud, Minnesota, United States

Key Dates

Start Date

February 19, 2019

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2030

Last Updated

November 29, 2024

Enrollment

145

ESTIMATED participants

Conditions

Stress Urinary Incontinence

Interventions

ProACT Adjustable Continence Therapy for Men

DEVICE

Contacts

Patrick Gora

CONTACT

7636949880 pgora@uromedica-inc.com

Timothy C Cook, PhD

CONTACT

7636949880 regulatory@uromedica-inc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ProACT Post-Approval Study

Inclusion Criteria

Exclusion Criteria

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Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

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Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women

Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial

Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence