NCT05148156Recruiting
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)
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Nov 2021
- Start date
- 11 Feb 2026
- Primary completion date
- Sept 2027
- Lead sponsor
- Northwell Health
- Diseases
- Prostate cancer
- NCT number
- NCT05148156
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 11 Feb 2026 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently enrolled in or plans to enroll in any concurrent drug or device study
- Concurrent androgen deprivation therapy
- Diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- Subject has been catheterized or has a PVR \> 400 ml in the 14 days prior to the surgical procedure
Other illness
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Neurogenic bladder or other neurologic disorder that affects bladder function
- History of lower urinary tract surgery
Other
- Life expectancy \< 2 years
- 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
- Diagnosis of polyneuropathy (e.g., diabetic)
- Subject has diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
- Current diagnosis of bladder stones
Who the study is looking for
- 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
Age in the registry: 50 years to 99 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwell Health Coordinator of this site? Confirm its status | Syosset | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.