ProACT Post-Approval Study

May 19, 2023 updated by: Uromedica

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

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.

Study Overview

Status

Recruiting

Study Type

Interventional

Enrollment (Anticipated)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Colorado
      • Denver, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
        • Principal Investigator:
          • Brian Flynn, MD
        • Sub-Investigator:
          • Nate Coddington, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Lawrence Yeung, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Lindsey Hartsell, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Bahaa Malaeb, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ProACT Adjustable Continence Therapy for Men
Patients implanted with 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urethral Strictures
Time Frame: 5 years
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
5 years
Device Erosions
Time Frame: 5 years
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
5 years
Incontinence Quality of Life Questionnaire (I-QoL)
Time Frame: 5 years
Results on Validated Incontinence Quality of Life Questionnaire
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy
Time Frame: 5 years

This data will be collected with a "Post ProACT Explant Subsequent Therapy Questionnaire".

This questionnaire will ask 3 questions regarding the ProACT therapy

  1. Did the ProACT therapy have a detrimental effect on the difficulty of the subsequent implant surgery?
  2. Did the ProACT therapy significantly increase the time required to implant the subsequent implant surgery?
  3. Did the ProACT therapy increase the surgical complication rate during the subsequent implant surgery?

The scale for each question is 0-1. 0 Meaning no effect (a "No" response on the questionnaire) and 1 being some effect ("Yes" response on the questionnaire). No effect (0) on subsequent SUI therapies is the better outcome.

5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Timothy C Cook, PhD, Uromedica, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Anticipated)

September 1, 2025

Study Completion (Anticipated)

September 1, 2030

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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