ProAct
Post Approval Study Plan of the ProACT Adjustable Continence Therapy for Men
Inclusion Criteria:
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Subject is a male of at least 50 years of age
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Subject demonstrates stress urinary incontinence
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Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery
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Subject is willing and able to undergo surgical implantation of ProACT devices
Exclusion Criteria:
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Existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy
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Prostate surgery or any anti-incontinence surgery within the last 12 months
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Artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo
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Untreated or unsuccessfully treated detrusor instability or over-activity
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Radiation therapy in the prostatic area within the last 12 months
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Atonic bladder has had or currently has bladder cancer
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Detrusor sphincter dyssynergia