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

NCT ID: NCT05148156

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2028-03-31

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).

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.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Urolift

Intervention Type: DEVICE

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

Interventions

Urolift

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

NeoTract, Inc.

INDUSTRY

Sponsor Role: collaborator

Teleflex

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bilal Chughtai, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health

Locations

Northwell Health

Syosset, New York, United States

Countries

United States

References

Ng M, Leslie SW, Baradhi KM. Benign Prostatic Hyperplasia. 2024 Oct 20. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK558920/

Reference Type: BACKGROUND

PMID: 32644346 (View on PubMed)

McVary KT. BPH: epidemiology and comorbidities. Am J Manag Care. 2006 Apr;12(5 Suppl):S122-8.

Reference Type: BACKGROUND

PMID: 16613526 (View on PubMed)

Alcaraz A, Hammerer P, Tubaro A, Schroder FH, Castro R. Is there evidence of a relationship between benign prostatic hyperplasia and prostate cancer? Findings of a literature review. Eur Urol. 2009 Apr;55(4):864-73. doi: 10.1016/j.eururo.2008.11.011. Epub 2008 Nov 21.

Reference Type: BACKGROUND

PMID: 19027219 (View on PubMed)

Roehrborn CG. Prostatic Urethral Lift: A Unique Minimally Invasive Surgical Treatment of Male Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urol Clin North Am. 2016 Aug;43(3):357-69. doi: 10.1016/j.ucl.2016.04.008.

Reference Type: BACKGROUND

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Chialastri P, Chialastri A, Mueller T. Does Prostatic Urethral Lift Reduce Urinary Medications? Trends in Medical Treatment Before and After Prostatic Urethral Lift. J Endourol. 2021 May;35(5):657-662. doi: 10.1089/end.2020.0848. Epub 2021 Jan 20.

Reference Type: BACKGROUND

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Cihan Y. The role and importance of SBRT in prostate cancer. Int Braz J Urol. 2018 Nov-Dec;44(6):1272-1274. doi: 10.1590/S1677-5538.IBJU.2018.0484. No abstract available.

Reference Type: BACKGROUND

PMID: 30325604 (View on PubMed)

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Reference Type: BACKGROUND

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Jiang P, Krockenberger K, Vonthein R, Tereszczuk J, Schreiber A, Liebau S, Huttenlocher S, Imhoff D, Balermpas P, Keller C, Dellas K, Baumann R, Rodel C, Hildebrandt G, Junemann KP, Merseburger AS, Katz A, Ziegler A, Blanck O, Dunst J. Hypo-fractionated SBRT for localized prostate cancer: a German bi-center single treatment group feasibility trial. Radiat Oncol. 2017 Aug 18;12(1):138. doi: 10.1186/s13014-017-0872-2.

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Other Identifiers

24-0684

Identifier Type: -

Identifier Source: org_study_id