ProACT Post-Approval Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ProACT Adjustable Continence Therapy for Men.
- Who it may be relevant to
- Registry conditions: Stress Urinary Incontinence. Basic parameters: from 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Urethral Strictures [Time frame: 5 years]
- Device Erosions [Time frame: 5 years]
- Incontinence Quality of Life Questionnaire (I-QoL) [Time frame: 5 years]
Eligibility criteria
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%.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- University of Colorado — Denver
- University of Florida — Gainesville
- Emory University — Atlanta
- University of Kansas Medical Center — Kansas City
- University of Michigan — Ann Arbor
- CentraCare- St. Cloud — Saint Cloud
Identifiers
NCT: NCT03767595 · PAS001