What is BPH?
Benign Prostatic Hyperplasia, or BPH, is a condition in which the prostate enlarges as men get older. BPH is a very common condition that affects over 42 million men in the US1 and over 660 million aging men worldwide.2,3 Over 40% of men in their 50s and over 70% of men in their 60s have BPH.2 While BPH is a benign condition and unrelated to prostate cancer, it can greatly affect a man’s quality of life.
As the prostate enlarges, it presses on and blocks the urethra, causing bothersome urinary symptoms. If left untreated, BPH can lead to permanent bladder damage.4
Symptoms include:5,6
- Frequent need to urinate both day and night
- Weak or slow urinary stream
- A sense that you cannot completely empty your bladder
- Difficulty or delay in starting urination
- Urgent feeling of needing to urinate
- A urinary stream that stops and starts
Symptoms of BPH can cause loss of productivity, depression, and decreased quality of life.7
If you suffer from the above symptoms, you are not alone. BPH is the leading reason men visit a urologist.8
You can measure your BPH symptoms by taking the IPSS questionnaire. Sharing this information with your physician will help them understand the severity of your symptoms.
Even watchful waiting has its risks. Bladder outlet obstruction could result in irreversible bladder damage if left untreated4
The UroLift® System Treatment
What is the UroLift® System?
The UroLift® System is a proven minimally invasive procedure to treat an enlarged prostate. It is the only leading enlarged prostate procedure that does not require heating, cutting, or destruction of prostate tissue. The procedure is typically performed as a same-day outpatient procedure, including the office setting, under local anesthesia.9
Advantages of the UroLift® System
- Safe and effective10
- Risk profile better than reported for surgical procedures such as TURP11
- Rapid symptom relief12, better than reported for medications13
- Only leading BPH procedure shown not to cause new and lasting sexual dysfunction*10,13,14
- Covered by Medicare, national, and commercial plans**
- Typically no catheter required after treatment9,12
How Does The UroLift® System Work?
Step 1
The UroLift Delivery Device is placed through the obstructed urethra to access the enlarged prostate.
Step 2
Small UroLift Implants are permanently placed to lift and hold the enlarged prostate tissue out of the way and increase the opening of the urethra.
Step 3
The UroLift Delivery Device is removed, leaving an open urethra designed to provide symptom relief.
Indicated for the treatment of symptoms of an enlarged prostate up to 100 cc in men 45 years or older. As with any medical procedure, individual results may vary. Most common side effects are temporary and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate, and/or the inability to control the urge.11 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention. Speak with your doctor to determine if you may be a candidate.
- * No instances of new, sustained erectile or ejaculatory dysfunction in the L.I.F.T. pivotal study
- ** When medical criteria are met
- NeoTract US Market Model estimates for 2020
- Berry, S.J., Coffey, D.S., Walsh, P.C., & Ewing, L.L. (1984). The Development of Human Prostatic Hyperplasia with Age. The Journal of Urology 132(3), 474-479.
- US Census Bureau international database worldwide population estimates for 2020
- Tubaro, A., Carter, S., Trucchi, A., Punzo, G., Petta, S., & Miano, L. (2003). Early Treatment of Benign Prostatic Hyperplasia. Drugs & Aging 20, 185-195.
- Rosenberg, M.T., Staskin, D.R., Kaplan, S.A., MacDiarmid, S.A., Newman, D.K., & Ohl, D.A. (2007). A practical guide to the evaluation and treatment of male lower urinary tract symptoms in the primary care setting. The International Journal of Clinical Practice 61: 1535-1546.
- Vuichoud, C., & Loughlin, K.R. (2015). Benign prostatic hyperplasia: epidemiology, economics and evaluation. The Canadian Journal of Urology 22, 1-6.
- Speakman, M., Kirby, R., Doyle, S., & Ioannou, C. (2014). Burden of male lower urinary tracts symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) - focus on the UK. British Journal of Urology International 115(4), 508-519.
- IMS Health NDTI Urology Specialty Profile Report 2013
- Shore, N., Freedman, S., Gange, S., Moseley, W., Heron, S., Tutrone, R., Brown, T., & Barkin, J. (2014). Prospective multi-center study elucidating patient experience after prostatic urethral lift. The Canadian Journal of Urology 21(1), 7094-7101.
- Aljuri, N., Gilling, P., & Roehrborn, C. (2017). How I do it: Ballon tamponade of prostatic fossa following Aquablation. The Canadian Journal of Urology 24(4), 8937-8940.
- Sønksen, J., Barber, N.J., Speakman, M.J., Berges, R., Wetteraurer, U., Greene, D., Sievert, K.D., Chapple, C.R., Montorsi, F., Patterson, J.M., Fahrenkrug, L., Schoenthaler, M., & Gartzke, C. (2015). Prospective, Randomized, Multinational Study of Prostatic Urethral Lift Versus Transurethral Resection of the Prostate: 12-month Results from the BPH6 Study. European Urology 68(4), 643-652.
- Roehrborn, C.G., Gange, S.N., Shore, N.D., Giddens, J.L., Bolton, D.M., Cowan, B.E., Brown, B.T., McVary, K.T., Te, A.E., Gholami, S.S., Rashid, P., Moseley, W.G., Chin, P.T., Dowling, W.T., Freedman, S.J., Incze, P.F., Coffield, K.S, Borges, F.D, & Rukstalis, D.B. (2013). Multi-center randomized controlled blinded study of the prostatic urethral lift for the treatment of LUTS associated with prostate enlargement due to BPH: the LIFT study. The Journal of Urology 190(6), 2161-2167.
- AUA BPH Guidelines
- McVary, K.T., Gange, S.N., Gittelman, M.C., Goldberg, K.A., Patel, K., Shore, N.D., Levin, R.M., Rousseau, M., Beahrs, J.R., Kaminetsky, J., Cowan, B.E., Cantrill, C.H., Mynderse, L.A., Ulchaker, J.C., Larson, T.R., Dixon, & C.M., Roehrborn, C.G. (2016). Erectile and Ejaculatory Function Preserved With Convective Water Vapor Energy Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: Randomized Controlled Study. The Journal of Sexual Medicine 13(6), 924-933.
Frequently Asked Questions
What is the UroLift® Delivery Device?
The UroLift® Delivery Device is a single-use, sterile medical device that contains one UroLift Implant. Patients typically require 4-6 implants during a UroLift System treatment. The Delivery Device is inserted transurethrally through a rigid sheath under cystoscopic visualization in order to reach the targeted area of obstruction. See Procedures and Device for more information.
What is the UroLift Implant?
The UroLift Implants are small permanent implants that hold the obstructing prostatic lobes apart. They are deployed through a needle that comes out of the delivery device. Each implant is made with common implantable materials: nitinol, stainless steel, and suture. Typically, 4-6 implants are placed into the prostate.
Who is a good candidate for the UroLift® System treatment?
You may be a good candidate if you are a male, 45 years of age or older, and have symptoms relating to BPH. Speak with your urologist to see if the UroLift® System procedure is right for you. If you have a known allergy to nickel, titanium or stainless steel, talk to your doctor about your allergy before getting a UroLift System treatment.
Is the treatment permanent or can it be removed?
The Implants are intended to be permanent. The implant is made up of standard surgical implantable materials: a nitinol capsular tab, a stainless steel urethral tab, and polyethylene suture that holds the two tabs together. Your doctor can simply remove the urethral implant, if needed. The suture can be cut and the urethral endpiece can be retrieved with a standard grasper. The capsular tab will remain in place inside the body.
Who performs the UroLift System treatment?
A urologist, a doctor who specializes in the treatment of diseases of the urinary system and sex organs, uses the UroLift System to treat urinary symptoms due to BPH. Comprehensive training is provided to the urologists prior to using the UroLift System.
What examinations do I need prior to the UroLift® System treatment?
The examination performed will be determined by your physician. The physician will likely ask you to fill out a questionnaire to assess your symptoms, otherwise known as IPSS (International Prostate Symptom Score). Additionally, some of the common examinations include Digital Rectal Exam (DRE), Transrectal Ultrasonography (TRUS), Bladder Ultrasound, and Urinalysis.
What should I expect during the treatment? Is it painful? How long does it take?
If you and your doctor decide that the UroLift® System treatment is right for you, your doctor will provide you with more detailed information relating to the treatment. In general, the UroLift System is a minimally invasive treatment that entails minimal downtime. Your doctor will use the UroLift Delivery Device to deploy permanent implants to relieve obstruction caused by the enlarged prostate that is pressing on your urethra. The procedure, which usually takes less than an hour, may be performed under local or general anesthesia and you may be given medication to feel comfortable during the treatment. This typically helps minimize discomfort during the procedure, though everyone’s definition for pain and discomfort varies greatly. Typically, no catheter and no overnight stay is required post-treatment.
What happens post-treatment, during the recovery period? Are meds required?
After the treatment, patients typically go home the same day without a catheter. There is minimal downtime post-treatment and many patients experience symptom relief in as early as 2 weeks.4 Patients may experience some urinary discomfort during the recovery period. The most common side effects may include blood in the urine, some pain or discomfort when urinating, some increased urge to go and discomfort in the pelvis that typically resolve within two to four weeks after the procedure.
What happens if the implants need to be removed?
The implant is made up of standard surgical implantable materials: a nitinol tab, a stainless-steel tab, and polyethylene suture that holds the two tabs together. Your doctor can remove the implant from the urethra, if needed.
Does the treatment affect my sexual function?
Clinical studies have shown the UroLift System treatment does not cause new, sustained instances of erectile or ejaculatory dysfunction. The same cannot always be said of other BPH therapies such as TURP, laser, and even medication.
Will the UroLift Implants affect a digital rectal exam (DRE)?
The implants are not expected to interfere with a DRE. The implants are placed on the anterior (front) side of the prostate, and a DRE is conducted on the posterior (back) side of the prostate.
How does the UroLift® System treatment compare to other treatment options?
The UroLift® System treatment has been found to be a safe and effective treatment for symptoms related to BPH. Its risk profile is better than most traditional surgical options, and patients report symptom relief better than reported with medications (add reference). In the large, pivotal study on the UroLift System there were no instances of new, sustained erectile dysfunction or ejaculatory dysfunction.
What clinical data is available?
We have over 25 peer-reviewed publications demonstrating the UroLift System is safe and effective. Improvement in urinary symptoms, as seen through reduction in IPSS (International Prostate Symptom Score), has been consistent across the various studies, showing rapid relief in as early as two weeks and sustained effect to five years.
What are the side effects?
In our clinical studies, the most common side effects reported were mild to moderate and include pain or burning with urination, blood in the urine, pelvic pain, urgent need to urinate and/or the inability to control the urge. Most symptoms resolved within two to four weeks after the procedure.
Does my insurance cover the treatment?
The UroLift System treatment is covered by Medicare and many private insurers. Contact your insurance provider for your specific coverage information.
