RECRUITING

ProACT Post-Approval Study

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Conditions

Stress Urinary Incontinence

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-02-19
Study Completion:2030-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03767595

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject is a male of at least 50 years of age.
  2. 2. Subject demonstrates stress urinary incontinence.
  3. 3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
  4. 4. Subject is willing and able to undergo surgical implantation of ProACT devices.
  5. 5. Subject is willing and able to comply with study-required
  6. 6. Subject is willing and able to sign the approved informed consent.
  7. 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. 8. Subject has a negative urine culture.
  9. 9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.
  10. 10. Subject meets ONE of the following criteria:
  11. 1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
  12. 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;
  13. 11. Physician determines subject to be a suitable surgical candidate.
  1. 1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.
  2. 2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.
  3. 3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.
  4. 4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.
  5. 5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.
  6. 6. Subject has an atonic bladder.
  7. 7. Subject had, presently has, or is suspected of having bladder cancer.
  8. 8. Subject has untreated or unsuccessfully treated bladder stones.
  9. 9. Subject has detrusor sphincter dyssynergia.
  10. 10. Subject has known hemophilia or a bleeding disorder.
  11. 11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).
  12. 12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.

Contacts and Locations

Study Contact

Patrick Gora
CONTACT
7636949880
pgora@uromedica-inc.com
Timothy C Cook, PhD
CONTACT
7636949880
regulatory@uromedica-inc.com

Principal Investigator

Timothy C Cook, PhD
STUDY_DIRECTOR
Uromedica, Inc.

Study Locations (Sites)

University of Colorado
Denver, Colorado, 80045
United States
University of Florida
Gainesville, Florida, 32610
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Kansas Medical Center
Kansas City, Kansas, 66103
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
CentraCare- St. Cloud
Saint Cloud, Minnesota, 56303
United States

Collaborators and Investigators

Sponsor: Uromedica

  • Timothy C Cook, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2019-02-19
Study Completion Date2030-09-01

Study Record Updates

Study Start Date2019-02-19
Study Completion Date2030-09-01

Terms related to this study

Additional Relevant MeSH Terms

  • Stress Urinary Incontinence