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

January 23, 2026 updated by: Northwell Health

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

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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syosset, New York, United States, 11791
        • Northwell Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Urolift
Study intervention involves a one-time administration of Urolift in out-patient setting prior to Stereotactic body radiation therapy (SBRT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IPSS scores from baseline and one year post treatment
Time Frame: At baseline and one year post treatment
Patients will take a International Prostatic Symptom Score (IPSS) questionnaire to evaluate symptom severity at baseline and 1 year post treatment. IPSS scores range from 1 to 35, with 1-7 indicating mild symptoms, 8-19 indicating moderate symptoms, 20-35 indicating severe symptoms.
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
Patient will take the International Index of Erectile Function (IIEF) to evaluate changes in sexual function of patients through study completion, an average of 1 year. IIEF scores range from 6 to 30. IIEF lower scores indicate severe erectile dysfunction, while higher scores indicate mild/no erectile dysfunction.
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

Patients will take the Men's sexual health questionnaire (MSHQ) to further evaluate patients' ability to have sex with their partner(s) or masturbate through study completion, an average of 1 year.

Overall, study subjects will be assessed for possible change in hypogonadal, sexual function, and pain symptoms. Scores range from 16 to 125. Lower scores are considered most symptomatic, higher scores are least symptomatic.
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
Patients will use a visual analog scale (VAS) to describe their pain through study completion, an average of 1 year, to see if there is any changes in pain post treatment. Self-assessed maximum pain reported using a 0-100mm visual analog scale, where 100 signifies maximum pain and 0 signifies no pain.
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

Patients will use a overactive bladder short form (OAB-SF) to describe their overactive bladder symptoms through study completion, an average of 1 year, to see if there is any changes in symptoms.

The OAB-q SF has 2 main subscales: Symptom bother and Health-Related Quality of Life (HRQOL). The two subscales are summed separately and transformed into scores ranging from 0 to 100. A higher score on the symptom bother scale indicates a greater symptom severity and a higher score on the HRQOL scale indicates a better HRQOL, so they are inversely related to each other. Since the OAB-q SF has no total score, higher scores indicate more severe symptoms or better quality of life, respectively. Lower scores indicate less severe symptoms or worse quality of life respectively.
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

Patients will use a short form 12 (SF-12) survey to measure their quality of life through study completion, an average of 1 year, to see if there is any changes.

Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the PCS-12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the MCS-12 may be indicative of 'clinical depression'.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in medication usage through study completion, an average of 1 year
Time Frame: Through study completion, an average of 1 year
Patients will list their medication usage through study completion, an average of 1 year to see if there is any changes in medications after the study treatment
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Collaborators

Teleflex
NeoTract, Inc.

Investigators

  • Principal Investigator: Bilal Chughtai, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2021

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-0684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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