ProACT Therapy for the Treatment of Stress Urinary Incontinence in Males (ProACT)
Clinical Investigation of the ProACT Adjustable Continence Therapy for Treatment of Post-Prostatectomy Stress Urinary Incontinence
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a prospective, non-randomized multi-center investigation. Multiple measurements using 24 hour pad weight and pad count, validated questionnaires, voiding diaries will be used to evaluate the achievement of the study objectives. Subjects will be followed for a minimum of 18 months following implantation. Subjects will be requested to continue annual follow-ups through the FDA approval.
The purpose of the study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 109 male patients. The ProACT device is designed to treat men who have stress urinary incontinence arising from intrinsic sphincter deficiency following an operation performed on the prostate for cancer or for benign prostatic hyperplasia. Two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in pad weight at 18 months follow-up compared to the pad weight results at baseline.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Victoria, British Columbia, Canada, V8T5G1
- Can-Med Clinical Research Inc.
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Quebec
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Fleurimont, Quebec, Canada, J1H5N4
- CHUS-Fleurimont
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Tauranga, New Zealand
- Urology Bay of Plenty (formerly Promed Urology)
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Arizona
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Tucson, Arizona, United States, 85724
- University of Arizona
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California
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Los Angeles, California, United States, 90027
- Kaiser Permanente-Los Angeles
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Florida
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Pembroke Pines, Florida, United States, 33028
- The Pelvic Clinic
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Vero Beach, Florida, United States, 32960
- Indian River Urology
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Illinois
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Kankakee, Illinois, United States, 60901
- Urological Surgeons
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Minnesota
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Saint Paul, Minnesota, United States, 55102
- Metro Urology
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Missouri
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Kansas City, Missouri, United States, 64123
- Kansas City Urology Care
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergone either a radical prostatectomy, transurethral resection of the prostate or other prostate surgery at least 12 months prior without radiation therapy
- Demonstrate primary stress urinary incontinence
- Male subjects at least 45 years of age
- Willing and able to undergo surgical implantation of the ProACT devices
- Willing and able to comply with the follow-up requirements
- Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
- Willing and able to sign the informed consent
- Positive 24 hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests)
- Experiences at least 3 incontinence episodes per day during two baseline voiding diaries.
- Negative Urine culture
- No recurrent stricture at the anastamosis
- No known urogenital malignancy other than previously treated prostate cancer
- Physician determines subject to be suitable surgical candidate
Exclusion Criteria:
- Primarily Urge incontinence
- Detrusor instability or over-activity
- Residual volume greater that 100 ml or greater than 25% of the total bladder capacity after voiding.
- Subject has/had or is suspected of having bladder cancer
- History of recurrent bladder stones
- Neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- Known hemophilia or a bleeding disorder
- Abnormal PSA (Prostate Specific Antigen), according to sites laboratory standards, unless further investigation confirms no underlying prostate malignancy.
- Known sever contrast solution allergy
- Has a genitourinary mechanical prosthesis other than previous sling procedure (e.g., Artificial Urinary sphincter, implantable penile prosthesis)
- Has a urethral stricture that prevents passage of an 18 F cystoscope or has had more than one urethrotomy
- Undergone bulking procedure within 6 months of the baseline assessment
- Subject is currently enrolled or plans to enroll in another device or drug clinical trial.
- Subject is currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment.
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 |
|---|---|
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Experimental: ProACT (Adjustable Continence Therapy)
Implantation with ProACT (Adjustable Continence Therapy), Single Arm
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Implantable device to reduce urinary stress incontinence
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Efficacy: Demonstrate the Efficacy of the ProACT Device in Reducing Incontinence as Measured by the 24-hour Pad Weight at 18 Months Compared to Baseline. A Subject is a Success if he Demonstrates a 50% Reduction.
Time Frame: 18 month follow-up
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The percentage of participants with 50% reduction in pad weight.
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18 month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tim Cook, Ph.D, Uromedica, Inc.
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UM02
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