- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03767595
ProACT Post-Approval Study
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patrick Gora
- Phone Number: 7636949880
- Email: pgora@uromedica-inc.com
Study Contact Backup
- Name: Timothy C Cook, PhD
- Phone Number: 7636949880
- Email: regulatory@uromedica-inc.com
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80045
- Recruiting
- University of Colorado
-
Contact:
- Andrea Pina
- Email: andrea.pinalimones@cuanschutz.edu
-
Principal Investigator:
- Brian Flynn, MD
-
Sub-Investigator:
- Nate Coddington, MD
-
-
Florida
-
Gainesville, Florida, United States, 32610
- Recruiting
- University of Florida
-
Contact:
- John Marks, DHSc, CCRP
- Phone Number: 352-273-5618
- Email: John.Marks@urology.ufl.edu
-
Principal Investigator:
- Lawrence Yeung, MD
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University
-
Principal Investigator:
- Lindsey Hartsell, MD
-
Contact:
- Sierra Williams
- Phone Number: 404-778-4729
- Email: sierra.williams@emory.edu
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Nailah Henry
- Email: hnailah@med.umich.edu
-
Principal Investigator:
- Bahaa Malaeb, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject is a male of at least 50 years of age.
- Subject demonstrates stress urinary incontinence.
- Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.
- Subject is willing and able to undergo surgical implantation of ProACT devices.
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.
- Subject is willing and able to sign the approved informed consent.
- 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).
- Subject has a negative urine culture.
- Subject has no known urogenital malignancy, other than previously treated prostate cancer.
Subject meets ONE of the following criteria:
- Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng/mL;
- 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;
- Physician determines subject to be a suitable surgical candidate.
Exclusion Criteria:
- Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.
- Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.
- Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.
- Subject has undergone radiation therapy in the prostatic area within the last 12 months.
- Subject has untreated or unsuccessfully treated detrusor instability or over-activity.
- Subject has an atonic bladder.
- Subject had, presently has, or is suspected of having bladder cancer.
- Subject has untreated or unsuccessfully treated bladder stones.
- Subject has detrusor sphincter dyssynergia.
- Subject has known hemophilia or a bleeding disorder.
- Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).
- Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.
Study Plan
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
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
Sponsor
Investigators
- Study Director: Timothy C Cook, PhD, Uromedica, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAS001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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