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).
Subject is 50 - 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
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)
Single group
Urolift
DeviceStudy intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).
Change in IPSS scores from baseline and one year post treatment
Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
Change in IIEF score through study completion, an average of 1 year
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
Change in MSHQ through study completion, an average of 1 year
Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year. Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
Change in VAS score through study completion, an average of 1 year
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
Change in medication usage through study completion, an average of 1 year
Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment
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