Stress Urinary IncontinenceNCT03767595
ProACT Post-Approval Study
A study testing ProACT Adjustable Continence Therapy for Men in people with Stress Urinary Incontinence, run by Uromedica at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- ProACT Adjustable Continence Therapy for Men
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Feb 2019to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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%.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lisa DRAPER contact
14 sites in 1 country
United States14 sites, 14 recruiting
- Recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Megan McGonagle, MSN, RN, PCCN, Megan.mcgonagle@jefferson.edu
Matthew Loecher, MD
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Nailah Henry, hnailah@med.umich.edu
Bahaa Malaeb, MD
- Recruiting
Urology Partners of North Texas Research Institute
Arlington, Texas, 76017
Grace Yoon, gyoon@folioclinicalresearch.com
Keith Xavier, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Nahir Imtiaz, sbimtia@emory.edu
Lindsey Hartsell, MD
- Recruiting
University of Colorado
Denver, Colorado, 80045
Andrea Pina, andrea.pinalimones@cuanschutz.edu
Brian Flynn, MD
- Recruiting
University of Florida
Gainesville, Florida, 32610
John Marks, DHSc, CCRP, 352-273-5618, John.Marks@urology.ufl.edu
Lawrence Yeung, MD
- Recruiting
Urological Research Network Corp
Hialeah, Florida, 33016
Isabel Lopez, isabel@besturology.net
Edward Gheiler, MD
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66103
Kirk Redger, MD, 913-588-1227, kredger@kumc.edu
- Recruiting
University of Southern California
Los Angeles, California, 90033
Julissa Morales, julissa.morales@med.usc.edu
Jeffrey Loh-Doyle, MD
- Recruiting
DHR Health Institute for Research and Development
McAllen, Texas, 78504
Clarisa Medina, c.medina@dhrhealth.com
Henry Ruiz, MD
- Recruiting
CHI Health Research
Omaha, Nebraska, 68124
Jan Mitchell, jan.mitchell@commonspirit.org
Michael Feloney, MD
- Recruiting
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Rachel Reading, rachel.reading@ahn.org
Tibetha Santucci, tibetha.santucci@ahn.org
- Recruiting
CentraCare- St. Cloud
Saint Cloud, Minnesota, 56303
Andrew Windsperger, MD, 320-229-4547, andrew.windsperger@centracare.com
- Recruiting
Sutter Health
Santa Barbara, California, 93110
Morgan Caldwell-Holden, morgan.caldwell-holden@sutterhealth.org
Megan Martinez, megan.martinez@sutterhealth.org
About this study
Official title: 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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- ProACT Adjustable Continence Therapy for Men
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProACT Adjustable Continence Therapy for MenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ProACT Adjustable Continence Therapy for Men | Experimental | Patients implanted with ProACT Adjustable Continence Therapy for Men Receives: Device: ProACT Adjustable Continence Therapy for Men |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethral Strictures
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Measured: 5 years
Device Erosions
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
Measured: 5 years
Incontinence Quality of Life Questionnaire (I-QoL)
Results on Validated Incontinence Quality of Life Questionnaire
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start19 Feb 2019
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uromedica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Johnson, PhD, Study director, Uromedica, Inc. / Coloplast, Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767595
- Sponsor's protocol ID
- PAS001
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2018
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
- ClinicalTrials.gov ID
- NCT03767595
- Acronym / sponsor ID
- PAS001
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- UromedicaIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ProACT Adjustable Continence Therapy for Men | Experimental | Device: ProACT Adjustable Continence Therapy for MenPatients implanted with ProACT Adjustable Continence Therapy for Men |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProACT Adjustable Continence Therapy for MenThe 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. | Device | ProACT Adjustable Continence Therapy for Men |
Primary outcome
Urethral Strictures
Time frame: 5 years
Cumulative incidence of ProACT-related clinically relevant urethral strictures over 5 years of follow up.
Device Erosions
Time frame: 5 years
Cumulative incidence of ProACT device erosions over 5 years of follow-up.
Incontinence Quality of Life Questionnaire (I-QoL)
Time frame: 5 years
Results on Validated Incontinence Quality of Life Questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa DRAPER contact
Philip Johnson, PhD study director
Uromedica, Inc. / Coloplast, Corp
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProACT Adjustable Continence Therapy for Men in people with Stress Urinary Incontinence, run by Uromedica at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Kelly, PhD (6124698882, usmtk@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urethral Strictures (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.