ProACT Post-Approval Study

Part of paid clinical trials in Denver, Colorado.

Sponsor
Uromedica
Study ID
NCT03767595
Status
Recruiting
Apply to this trial

Conditions

  • Stress Urinary Incontinence

Eligibility Criteria

Sex
MALE
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ProACT Adjustable Continence Therapy for Men — DEVICE
    The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.

Study Details

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.

Key Dates

Start date
Feb 19, 2019
Status verified
Nov 2024
Primary completion
Sep 1, 2025
Completion
Sep 1, 2030

Study Design

Enrollment
145 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ProACT Adjustable Continence Therapy for Men
    Patients implanted with ProACT Adjustable Continence Therapy for Men

Primary Outcome Measure

Urethral Strictures [ Time Frame: 5 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of ColoradoDenverColorado80045
Brian Flynn, MD
Nate Coddington, MD
University of FloridaGainesvilleFlorida32610
John Marks, DHSc, CCRP
[email protected]
352-273-5618
Lawrence Yeung, MD
Emory UniversityAtlantaGeorgia30322
Sierra Williams
[email protected]
404-778-4729
Lindsey Hartsell, MD
University of Kansas Medical CenterKansas CityKansas66103
Kirk Redger, MD
[email protected]
913-588-1227
University of MichiganAnn ArborMichigan48109
Nailah Henry
[email protected]
Bahaa Malaeb, MD
CentraCare- St. CloudSaint CloudMinnesota56303
Andrew Windsperger, MD
[email protected]
320-229-4547

Find similar trials in Denver, CO

By research site
University of Colorado· Denver, COUniversity of Florida· Gainesville, FLEmory University· Atlanta, GAUniversity of Kansas Medical Center· Kansas City, KSUniversity of Michigan· Ann Arbor, MICentraCare- St. Cloud· Saint Cloud, MN

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