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

Part of paid clinical trials in Syosset, New York.

Sponsor
Northwell Health
Study ID
NCT05148156
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
50 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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 Dates

First listed
Dec 8, 2021
Start date
Feb 11, 2026
Status verified
Sep 2026
Primary completion
Sep 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Urolift
    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.

Primary Outcome Measure

Change in IPSS scores from baseline and one year post treatment [ Time Frame: At baseline and one year post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell HealthSyossetNew York11791
Jennifer Polo, CCRC
[email protected]
516-628-5910
Bilal Chughtai, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwell Health· Syosset, NY

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