Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)
Northwell Health
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).
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 tota…
Eligibility
- Age range
- 50–99 years
- Sex
- Male
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 * 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 infectio…
Interventions
- DeviceUrolift
Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).
Location
- Northwell HealthSyosset, New York