Urolift System for Treatment BPH and Enlarged Prostate

Urolift System for Treatment of BPH / Enlarged ProstateInnovations in Treatment of Enlarged Prostate

Alex Shteynshlyuger MD

Board Certified UrologistDirector of Urology

New York Urology Specialists2014

www.NewYorkUrologySpecialists.com

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.


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.


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.


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


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.


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.


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



Minimally Invasive In-Office Treatment OptionsMicrowave – 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.



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


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


L.I.F.T Randomized Controlled StudyJ 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



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



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.


Outcome Measure

PUL-ITT Group Mean, SD (No. responses) - UroliftControl 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

L.I.F.T Randomized Controlled Study


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


The Role of Urolift in Treatment of Men with BPH.

At New York Urology Specialists we have a very diverse patient populationSexual Side Effects of BPH Treatment Are ImportantMany men who are young with symptoms of enlarged prostateMany 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


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


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


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.


Who Should NOT Have Urolift

Suspect Other Abnormalities:Risk factors for prostate cancer: abnormal DRE / elevated PSA, PHI or 4KScoreEvaluate patients for prostate cancer: prostate biopsy prior to urolift


Questions about BPH Treatment or Urolift?

Alex Shteynshlyuger [email protected]


Health & Medicine

Urolift System for Treatment BPH and Enlarged Prostate