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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: Urolift


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm study, involving one time administration of Urolift in outpatient setting prior to stereotactic body radiation therapy
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IPSS scores from 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stereotactic body radiation therapy, urolift, prostatic urethral lift, dysuria, nocturia, minimally invasive therapy