Health & Medicine

Urolift System for Treatment BPH and Enlarged Prostate

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Innovations in Treatment of BPH and Enlarged Prostate: The emerging role of the new transprostatic implant using the Urolift System for treatment of BPH symptoms caused by enlarged prostate. Discussion of the clinical trial results, treatment options for #BPH and where does #Urolift procedure fit in the modern treatment for enlarged #prostate.
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  • 1. Urolift System for Treatment of BPH / Enlarged Prostate Innovations in Treatment of Enlarged Prostate Alex Shteynshlyuger MD Board Certified Urologist Director of Urology New York Urology Specialists 2014 www.NewYorkUrologySpecialists.com
  • 2. Why Urolift for BPH? New York Urology Specialists is the first practice in New York City, and one of the first practices in the United States, to offer Urolift as a treatment option for BPH for our patients. Why all the Excitement about the Urolift System? The goal of this presentation is to provide an overview of the treatment options for BPH and to explain where Urolift fits among other treatment options. www.NewYorkUrologySpecialists.com
  • 3. What is BPH or Enlarged Prostate? Who Gets it? BPH refers to benign prostatic hypertrophy, a medical term for enlarged prostate. What causes prostate to grow? Over time, under hormonal influence (from testosterone) the prostate increases in size. Prostate gland has volume of 15-20 ml or grams in young men (20-30 years old). By the time men reach age 50, it is not uncommon for the prostate gland to grow to 40-50 grams. www.NewYorkUrologySpecialists.com
  • 4. Who Gets Enlarged Prostate? Prostate grows throughout a man’s life. Symptoms of prostate growth usually occurs in men who are over 40- 45 years old. It is fairly uncommon for men younger than 40 to experience symptoms of enlarged prostate. The symptoms are most common after age 50; as men age they are more likely to develop symptoms of enlarged prostate over time. www.NewYorkUrologySpecialists.com
  • 5. Symptoms of Enlarged Prostate / BPH Not all men with enlarged prostate develop symptoms of BPH. Some men with very large prostate may have minimal or no symptoms. Common symptoms of BPH: - Frequent urination - Feeling of incomplete bladder emptying - Need to urinate at night - Slow urine stream - Urgency to urinate; inability to hold urine - Blood in urine / Blood in semen www.NewYorkUrologySpecialists.com
  • 6. Why do some men have a very large prostate but no symptoms? Prostate can grown inward on the urethra or outward into the pelvis. If the prostate grows outward, it may become very large but cause no noticeable symptoms. If the prostate grows inward and pushes on urethra it may block the urethra and cause symptoms without being very large. Small change in the diameter of the urethra can have a tremendous effect on the flow of urine. www.NewYorkUrologySpecialists.com
  • 7. Warning about Self-Treatment The symptoms of Enlarged Prostate / BPH are similar to the symptoms caused by prostate cancer and bladder cancer. The men at risk for BPH are the same men who are at risk for prostate cancer (age >50). It is important to have a thorough urological evaluation including tumor markers (PSA, PHI, etc) for men at risk. www.NewYorkUrologySpecialists.com
  • 8. Treatment Options for Symptoms of Enlarged Prostate Medical Treatment: Sexual Side effects related mostly to ejaculation - Alpha blockers (Flomax, Rapaflo, etc) - Side Effects: retrograde ejaculation – reversible if medications are stopped - Combination of alpha blockers and alpha-reductase inhibitors (Proscar - Finasteride, dutasteride) - Side Effects: retrograde ejaculation; <5% risk of ED; lack of ejaculation - PDE5 inhibitors (Cialis, Viagra, etc) – true benefit uncertain as there is no effect on urinary flow - Side effects: many but few are dangerous; benefit of improved erections www.NewYorkUrologySpecialists.com
  • 9. Treatment Options for Symptoms of Enlarged Prostate Minimally Invasive In-Office Treatment Options Microwave – effective for mild to moderate symptoms; minimal sexual side effects; low rate of retrograde ejaculation; 30% need retreatment within 5 years TUNA – effective for mild to moderate symptoms; minimal sexual side effects; very low rate of retrograde ejaculation; 25% need retreatment within 3-5 years Urolift System for BPH – effective for mild to severe symptoms; no sexual side effects reported in studies; no retrograde ejaculation; <10% retreatment rate at 2 years. www.NewYorkUrologySpecialists.com
  • 10. Treatment Options for Symptoms of Enlarged Prostate Minimally Invasive Surgical Options: All have similar benefits and risks; require anesthesia; all lead to some sexual side effects. - Lasers (Greenlight, Holmium, etc) - TURP (Monopolar, Bipolar, etc) - Enucleation Open Prostatectomy - Rarely performed nowadays - Only performed for very large prostate - Sexual side effects and risks of surgery www.NewYorkUrologySpecialists.com
  • 11. Urolift Transprostatic Implant System Benefits of Transprostatic Implant using the Urolift System  Logically anatomic solution to obstruction.  Retracts the obstructing prostate tissue. Equivalent to angioplasty with a stent for blockage of the heart vessels.  Rapid relief of symptoms within days of treatment.  No need for daily medication use – alternative to medications  No risk of Erectile Dysfunction – vs current treatment options  No risk of Ejaculatory Dysfunction – vs current treatment options www.NewYorkUrologySpecialists.com
  • 12. L.I.F.T Randomized Controlled Study J Urol. 2013 Dec;190(6):2161-7. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. http://www.ncbi.nlm.nih.gov/pubmed/23764081 206 patients randomized to placebo or Urolift - All procedures done under local anesthesia (no IV sedation) - 4.9 implants on average per patient Baseline patient characteristics:  Average age = 67  mean prostate volume = 45 ml (moderately large prostate; average for age)  AUA SS = 22.2 (severe urinary symptoms)  Qmax = 8.9 (fairly poor urinary flow)  PSA=2.9  IIEF=13 (moderate to severe erectile dysfunction)  QOL = 4.6 www.NewYorkUrologySpecialists.com
  • 13. L.I.F.T Randomized Controlled Study J Urol. 2013 Dec;190(6):2161-7. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. http://www.ncbi.nlm.nih.gov/pubmed/23764081 Results Summary:  Can be done in the office under local anesthesia  Durability: good long-term effectiveness at 1 and 2 years  8-12 point drop in IPPS within weeks; minimal to no risk of hospital admission or readmission  Does not preclude future treatment with any of the other treatment options (Lasers, TURP, etc) Better than placebo: IPPS, Qmax, QOL, BPHII  Qmax improvement by 50% - improved urinary flow  AUA SS improvement by 50% (11 points) – improved urinary symptoms (frequent urination, incomplete bladder emptying, urgency, urination at night and quality of life)  Benefit unchanged after 2 years  No erectile dysfunction  No ejaculatory dysfunction www.NewYorkUrologySpecialists.com
  • 14. L.I.F.T Randomized Controlled Study J Urol. 2013 Dec;190(6):2161-7. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. http://www.ncbi.nlm.nih.gov/pubmed/23764081 Urolift – Results from Randomized Controlled Study shows benefit in every parameter measured: urinary function, sexual function and post-void residual. Results at 3 months are unchanged at 1 year. www.NewYorkUrologySpecialists.com Outcome Measure PUL-ITT Group Mean, SD (No. responses) - Urolift Control ITT Group Mean, SD (No. responses) - Placebo p Value (2-sample t - test)Baseline 3 Mos Change Baseline 3 Mos Change AUASI 22.2, 5.48 (140) 11.2, 7.65 (140) −11.1, 7.67 (140) 24.4, 5.75 (66) 18.5, 8.59 (66) −5.9, 7.66 (66) 0.003 Qmax (ml/sec) 8.02, 2.43 (126) 12.29, 5.40 (126) 4.28, 5.16 (126) 7.93, 2.41 (56) 9.91, 4.29 (56) 1.98, 4.88 (56) 0.005 QOL 4.6, 1.1 (140) 2.4, 1.7 (140) −2.2, 1.8 (140) 4.7, 1.1 (66) 3.6, 1.6 (66) −1.0, 1.5 (66) <0.001 BPHII 6.9, 2.8 (140) 3.0, 3.1 (140) −3.9, 3.2 (140) 7.0, 3.0 (66) 4.9, 3.2 (66) −2.1, 3.3 (66) <0.001 MSHQ-EjD 8.7, 3.1 (94) 10.9, 3.2 (94) 2.2, 2.5 (94) 8.8, 3.1 (50) 10.5, 3.5 (50) 1.7, 2.6 (50) 0.283 MSHQ-Bother 2.4, 1.7 (117) 1.6, 1.7 (117) −0.8, 1.5 (117) 2.2, 1.7 (60) 1.5, 1.7 (60) −0.7, 1.6 (60) 0.595 IIEF-5 13.3, 8.4 (132) 13.4, 9.2 (132) 0.1, 5.8 (132) 13.7, 8.5 (65) 15.2, 8.5 (65) 1.5, 6.4 (65) 0.139 PVR (ml) 85.5, 69.2 (140) 75.8, 83.9 (140) −9.7, 85.5 (140) 85.6, 70.8 (65) 63.4, 64.0 (65) −22.2, 70.7 (65) 0.306
  • 15. L.I.F.T Randomized Controlled Study www.NewYorkUrologySpecialists.com
  • 16. Who is a Good Candidate for Urolift Procedure?  Any age  Any comorbidities – can do it fairly safely on aspirin; patients with cardiac, pulmonary disease can have the procedure under local anesthesia just like everyone else.  Should NOT have a UTI – pretreat UTI if present  Predominantly lateral prostatic lobe obstruction  Minimal or no median prostate lobe obstruction  Minimal or moderate PVR (<250 ml) - But can treat men with high PVR and implant more implants if necessary - Treatment failure does not preclude other treatments www.NewYorkUrologySpecialists.com
  • 17. The Role of Urolift in Treatment of Men with BPH. At New York Urology Specialists we have a very diverse patient population Sexual Side Effects of BPH Treatment Are Important Many men who are young with symptoms of enlarged prostate Many men who are older with symptoms of enlarged prostate are very sexually active Many men who for health reasons are too frail to undergo surgical procedures www.NewYorkUrologySpecialists.com
  • 18. The Role of Urolift in Treatment of Men with BPH. Men with Mild to Moderate Urinary Symptoms -Medical Treatment is still the mainstay of treatment for BPH -Alpha blockers are both diagnostic and therapeutic -If moderate or good response to alpha-blockers, Urolift is an option for men who would prefer to avoid daily medications -Men who progress on medical therapy for BPH (symptoms worsen on flomax/uraxatral, proscar/avadart): - If quality for Urolift (cystoscopic examination, PVR), Urolift is a good option for many men www.NewYorkUrologySpecialists.com
  • 19. Urolift and Urinary Retention Men with transient urinary retention after a precipitating event: -Often a sign of underlying BPH/prostatic enlargement -Would probably benefit from treatment even if not very symptomatic; uroflow / PVR and urodynamics should be considered -Urolift may be an option in leu of medical treatment www.NewYorkUrologySpecialists.com
  • 20. Who Should NOT Have Urolift Men with complications that result from BPH that are life-threatening: -Renal insufficiency -Recurrent UTI/Sepsis Definitive treatment with Lasers or TURP should be promptly offered to patients. Urolift is not a good option for these men. Prostatic Bleeding -Urolift does not address the problem that occurs in men with prostatic bleeding which is hypervascularity and obstruction; very friable tissue Definitive treatment with Lasers or TURP should be promptly offered to patients. Urolift is not a good option for these men. www.NewYorkUrologySpecialists.com
  • 21. Who Should NOT Have Urolift Suspect Other Abnormalities: Risk factors for prostate cancer: abnormal DRE / elevated PSA, PHI or 4KScore Evaluate patients for prostate cancer: prostate biopsy prior to urolift www.NewYorkUrologySpecialists.com
  • 22. Questions about BPH Treatment or Urolift? Alex Shteynshlyuger MD info@NewYorkUrologySpecialists.com www.NewYorkUrologySpecialists.com
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