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RECRUITING Not applicable ClinicalTrials.gov

Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.

Sponsor: Northwell Health • ClinicalTrials.gov ID: NCT05148156

Registry updated: 2026-09-29
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Description

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).

Interventions

  • Urolift (Device)
    Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).

Eligibility criteria

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 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

Conditions

Benign Prostatic Hyperplasia

Locations

  • Northwell Health — Syosset, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record