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

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Conditions studied: Benign Prostatic Hyperplasia

In brief

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).

Key facts

Study ID

NCT05148156

Run by

Northwell Health

People needed

20

Starts

2021-12-15

Expected to finish

2028-03-01

Last updated by the study team

2026-01-27

Who can join

Age: 50 and older, up to 99. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwell Health — Syosset, New York, United States

Full record on ClinicalTrials.gov

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