Urolift for Reduction of SBRT

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    20
  • sponsor
    Weill Medical College of Cornell University
Updated on 4 October 2022
cancer
transrectal ultrasound
Accepts healthy volunteers

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).

Details
Condition Benign Prostatic Hyperplasia
Treatment UroLift
Clinical Study IdentifierNCT05148156
SponsorWeill Medical College of Cornell University
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 40 - 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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