Prostate Cancer Clinical Trial
Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
Summary
Many patients may face long-term urinary side effects following stereotactic body radiation therapy (SBRT), including increased urinary frequency, dysuria, and nocturia. The investigator hypothesizes that Urolift, which represents a novel minimally invasive therapy, may reduce acute and long-term urinary toxicity and side effects of radiation therapy (SBRT).
Full Description
Urolift is a standard of care treatment for BPH. It involves the placement of a stainless-steel urethral end piece tethered to a capsular tab to the left and right side of the prostatic urethra approximately 1.5cm distal to the bladder neck. It pulls and maintains the opening of a continuous channel through the prostatic urethra. A previous study examined the effect of Urolift on urinary symptoms and urinary medications at six months post-procedure.Urolift was associated with significant urinary improvements measured by IPSS and quality of life questionnaires and a reduction in the use of total medication as well as alpha-blockers and beta-3 agonists.
Eligibility Criteria
Inclusion Criteria:
Subject is 40 - 99 years of age
Subject has provided informed consent
Subject has diagnosis of prostate cancer requiring SBRT
Subject is able to complete self-administered questionnaires
Subject is a surgical candidate for Urolift
Subject has a diagnosis of BPH
Medical record documentation of prostate volume from 30-80 ml by TRUS
Absence of a middle lobe
Exclusion Criteria:
Life expectancy < 2 years
Currently enrolled in or plans to enroll in any concurrent drug or device study
Concurrent androgen deprivation therapy
Has an active infection (e.g., urinary tract infection or prostatitis)
Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
Subject has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
Subject has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
Diagnosis of lichen sclerosis
Neurogenic bladder or other neurologic disorder that affects bladder function
Diagnosis of polyneuropathy (e.g., diabetic)
History of lower urinary tract surgery
Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
Subject has been catheterized or has a PVR > 400 ml in the 14 days prior to the surgical procedure
Current diagnosis of bladder stones
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There is 1 Location for this study
New York New York, 10065, United States
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