Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
145 participants
INTERVENTIONAL
2019-02-19
2030-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ProACT Adjustable Continence Therapy for Men
Patients implanted with ProACT Adjustable Continence Therapy for Men
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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%.
50 Years
MALE
Yes
Sponsors
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Uromedica
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy C Cook, PhD
Role: STUDY_DIRECTOR
Uromedica, Inc.
Locations
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University of Colorado
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Michigan
Ann Arbor, Michigan, United States
CentraCare- St. Cloud
Saint Cloud, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Brian Flynn, MD
Role: backup
Nate Coddington, MD
Role: backup
Lawrence Yeung, MD
Role: backup
Lindsey Hartsell, MD
Role: backup
Bahaa Malaeb, MD
Role: backup
Other Identifiers
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PAS001
Identifier Type: -
Identifier Source: org_study_id