Recruiting

Urolift

Sponsor:

Northwell Health

Code:

NCT05148156

Conditions

Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

Urolift

Study Details

Brief 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

Study ID

NCT05148156

Start date

Feb 11, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Urolift

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

Primary outcome measure

  • Change in IPSS scores from baseline and one year post treatment [ Time Frame: At baseline and one year post treatment ]
  • Change in IIEF score through study completion, an average of 1 year [ Time Frame: Through study completion, an average of 1 year ]
  • Change in MSHQ through study completion, an average of 1 year [ Time Frame: Through study completion, an average of 1 year ]
  • Change in VAS score through study completion, an average of 1 year [ Time Frame: through study completion, an average of 1 year ]
  • Change in OAB-SF score through study completion, an average of 1 year [ Time Frame: Through study completion, an average of 1 year ]
  • Change in SF-12 score through study completion, an average of 1 year [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Jennifer Polo, CCRC

516-628-5910jpolo1@northwell.edu

Locations

Northwell Health

Recruiting

Syosset, New York, United States, 11791

Contacts

Jennifer Polo, CCRC

516-628-5910jpolo1@northwell.edu

Principal Investigator:

Bilal Chughtai, MD

More Information

Sponsor

Northwell Health

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Keywords

  • stereotactic body radiation therapy
  • urolift
  • prostatic urethral lift
  • dysuria
  • nocturia
  • minimally invasive therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.