Urolift Pre-SBRT for Reduced Urinary Toxicity in Patients With BPH and Prostate Cancer.
NCT05148156 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-01-27
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).
Conditions
- Benign Prostatic Hyperplasia
Interventions
- DEVICE
-
Urolift
Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).
Sponsors & Collaborators
-
NeoTract, Inc.
collaborator INDUSTRY -
Teleflex
collaborator INDUSTRY -
Northwell Health
lead OTHER
Principal Investigators
-
Bilal Chughtai, MD · Northwell Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 99 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-15
- Primary Completion
- 2027-06-30
- Completion
- 2028-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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