NCT05148156

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

Reduction of Urinary Toxicity of Stereotactic Body Radiation Therapy (SBRT) With Prostatic Urethral Lift (Urolift)

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: Male
• Age: 50 Years – 99 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Benign Prostatic Hyperplasia

Interventions

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

Timeline

• Start date: 2021-12-15
• Primary completion: 2027-06-01
• Completion: 2028-03-01
• First posted: 2021-12-08
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study