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

Northwell Health

Status: Suspended

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: Urolift

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05148156

24-0684

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 50 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Urolift

Experimental group

Description:

This is a single-arm study involving 1 year of follow-up. Study intervention involves a one-time administration of Urolift prior to SBRT for prostate cancer treatment.

Treatment:

Device: Urolift