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ProACT Post-Approval Study

NCT03767595 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-11-29

No results posted yet for this study

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.

Conditions

  • Stress Urinary Incontinence

Interventions

DEVICE

ProACT Adjustable Continence Therapy for Men

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.

Sponsors & Collaborators

  • Uromedica

    lead INDUSTRY

Principal Investigators

  • Timothy C Cook, PhD · Uromedica, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2025-09-01
Completion
2030-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03767595 on ClinicalTrials.gov