Frequently Asked Questions

BPH

No, BPH (Benign Prostatic Hyperplasia) is not a type of cancer. It is a benign condition, unrelated to prostate cancer, which can greatly affect a man's quality of life.

Yes, if left untreated, for some men there may be long-term risks. BPH can lead to permanent bladder damage1. When the bladder does not empty completely, the risk of developing urinary tract infections (UTIs) may increase2. Other serious problems can also develop over time, including bladder stones, blood in the urine, incontinence, or urinary retention2.

You may want to seek BPH treatment if you experience BPH symptoms such as urgent need to urinate, difficulty starting your urine stream, need to push or strain when urinating, dribbling, the sensation that the bladder is not empty after urinating, weak urine flow, increased frequency of urination, frequent nighttime urination, burning or pain during urination3. To help you and your doctor understand your symptoms, you can take and print out a short quiz to bring with you to your next visit.

Procedure

You may be a 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 treatment 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.

The FDA-cleared UroLift System is the only treatment that uses the Prostatic Urethral Lift (PUL) procedure. The UroLift System treatment is a proven, minimally invasive approach for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) that can get men off BPH medications and avoid major surgery. The UroLift System’s permanent implants, delivered during a minimally invasive outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue.

As with any medical procedure, individual results may vary. Speak with your urologist to see if the UroLift System treatment is right for you. Most common side effects are 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 resolve within two to four weeks after the procedure.

The UroLift System consists of a delivery device and small permanent implants.

  • The UroLift Delivery Device is placed through the obstructed urethra.
  • Small UroLift Implants are placed to lift or hold the enlarged prostate tissue out of the way like a curtain-tie. The Implants are delivered through a small needle that comes out of the delivery device and into the prostate.
  • The UroLift Delivery Device is removed, leaving an open urethra that provides symptom relief.

The UroLift System does not keep someone from having future BPH treatments if they are necessary.

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 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.

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 urologist prior to using the UroLift System.

The UroLift System

The UroLift Delivery Device is a single-use, sterile medical device that contains one UroLift Implant. The number of implants used in a procedure is determined by the treating physician and will vary by patient. The Delivery Device is inserted transurethrally through a rigid sheath under cystoscopic visualization in order to reach the targeted area of obstruction.

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.  The number of implants used in a procedure is determined by the treating physician and will vary by patient.

What to Expect

Your physician will determine which examinations are appropriate for you. 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.

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 often requires less recovery time than other procedures4. 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. This procedure 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-treatment4.

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. 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.

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 a polyethylene terephthalate suture that holds the two tabs together. Your doctor can remove the urethral tab, if needed. The suture can be cut and the urethral tab can be retrieved with a standard grasper. The capsular tab and part of the suture will remain in place inside your body.

Clinical studies have shown the UroLift System treatment does not cause new, sustained instances of erectile or ejaculatory dysfunction.4 The same cannot always be said of other BPH therapies such as TURP, laser, and even medication. The UroLift System is not intended to treat prior sexual dysfunction.

Non-clinical testing has demonstrated that the UroLift Implant is MR Conditional. A patient with this device can be safely scanned in an MR system immediately after placement meeting the following conditions:

  • Static magnetic field of 3.0 Tesla or less
  • Maximum spatial field gradient of 1,500 Gauss/cm (15 T/m) (extrapolated)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of continuous scanning (i.e., per pulse sequence) (First Level Controlled Operating Mode)

Under the scan conditions defined above, the UroLift Implant is expected to produce a maximum temperature rise of 2.4°C after 15 minutes of continuous scanning (i.e., per pulse sequence)

In non-clinical testing, the image artifact caused by the device extends approximately 15 mm from the UroLift Implant when imaged with a gradient echo pulse sequence and a 3.0 Tesla MRI system.

The safety of the delivery system has not been evaluated in the MR environment, and therefore, the implant deploying device should not be used within the MR environment.

Patient implant cards are provided to inform the patient that the UroLift implant is MR Conditional and can safely be scanned only under specific MR conditions.

If you have any questions about MRI safety, please consult your doctor.

 

You can also download the printable version of our patient MRI card.

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.

Insurance

Covered by Medicare, national and commercial plans, including all independent licensees of Blue Cross Blue Shield Association (BCBSA), when medical criteria are met.

Clinical

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 reported for most traditional surgical options, and patients report symptom relief better than reported with medications.4 In the large, pivotal study on the UroLift System, there were no instances of new, sustained erectile dysfunction or ejaculatory dysfunction.4

We have over 28 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.5

In our clinical studies, the most common side effects are temporary and can include discomfort when urinating, urgency, inability to control the urge, pelvic pain, and some blood in the urine.4 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention.

See the UroLift System Instructions for Use for more information.

How do I learn more about the UroLift System?

Our team is ready to answer your questions about the UroLift System treatment. Please fill out the contact form on our Contact Us page.

Source Information

  1. Tubaro et al. 2003 Drugs Aging Lieber et al.
  2. Barry M, Roehrborn C. Management of benign prostatic hyperplasia.Annu Rev Med.1997
  3. Abrams, et al., Neurourology and Urodynamics 2002; Maximilian, et al., BJU Intl 2012
  4. Roehrborn et al. Journal of Urology 2013 LIFT Study
  5. Roehrborn et al. Can J Urol 2017
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