ProACT Post-Approval Study
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
1 other identifier
interventional
145
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 6, 2018
CompletedStudy Start
First participant enrolled
February 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2030
ExpectedNovember 29, 2024
November 1, 2024
6.5 years
December 4, 2018
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Urethral Strictures
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
5 years
Device Erosions
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
5 years
Incontinence Quality of Life Questionnaire (I-QoL)
Results on Validated Incontinence Quality of Life Questionnaire
5 years
Other Outcomes (1)
Effect of ProACT on Subsequent Stress Urinary Incontinence(SUI) Therapy
5 years
Study Arms (1)
ProACT Adjustable Continence Therapy for Men
EXPERIMENTALPatients implanted with ProACT Adjustable Continence Therapy for Men
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uromedicalead
Study Sites (6)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Timothy C Cook, PhD
Uromedica, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 6, 2018
Study Start
February 19, 2019
Primary Completion
September 1, 2025
Study Completion (Estimated)
September 1, 2030
Last Updated
November 29, 2024
Record last verified: 2024-11