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What is BPH?

Example Example Example

What is BPH?

Benign Prostatic Hyperplasia, or BPH, is a condition in which the prostate enlarges as men get older. Over 70% of men in their 60s have BPH symptoms so it is very common1. While BPH is a benign condition and unrelated to prostate cancer, it can greatly affect a man’s quality of life.

The prostate is a male reproductive gland, about the size of a walnut, that produces fluid for semen. The prostate surrounds the urethra, which is the tube that carries urine from the bladder out of the body. As the prostate enlarges, it presses on and blocks the urethra, causing bothersome urinary symptoms such as:

  • 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

If you suffer from the above symptoms, you are not alone. BPH is one of the leading reasons for men to visit a urologist2.

Normal Prostate

Normal Prostate

Enlarged Prostate

Enlarged Prostate

 

  1. Berry, et al., Journal of Urology 1984
  2. IMS Health Urology 2013

BPH Treatment Options

If you have been diagnosed with an enlarged prostate due to BPH, there are several treatment options available. Consult your physician to determine which treatment is right for you.

Treatment Options

Watchful Waiting

When symptoms are mild, your doctor may just monitor your condition and ask you to track your symptoms before deciding if any treatment is necessary.

Medications

Your doctor may prescribe medications to manage your symptoms. These medications include alpha blockers which relax the muscles around the neck of your bladder, making it easier to urinate, and alpha reductase inhibitors which act to shrink the prostate. While medications can be helpful in relieving symptoms for some men, patients must continue taking them long-term to maintain the effects.

Some patients may suffer side-effects including dizziness, headaches, or sexual dysfunction. Some may not get adequate relief of their symptoms. Over 16% of men on medication for BPH discontinue treatment early for reasons such as being dissatisfied with side-effects or not getting adequate symptom relief.1

UroLift® System Treatment

The UroLift® System treatment is a minimally invasive approach to treating BPH that lifts or holds the enlarged prostate tissue out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue. Clinical data has shown that the UroLift System treatment is safe and effective in relieving lower urinary tract symptoms due to BPH without any impact to sexual function.

Learn more about how the UroLift System treatment works or visit our FAQ page for more information on the benefits, risks, and recovery.

Thermotherapies

Thermotherapies are minimally invasive treatments where heat energy such as microwave or radiofrequency is applied to destroy prostate tissue. Less invasive than TURP, these treatments are generally safe, can be performed under local anesthesia and provide moderate symptom relief for some patients.

Applying high heat to the prostate can cause tissue swelling and uncomfortable urinary symptoms during the healing period. Symptom relief does not occur immediately, and patients often need to have a catheter that is attached to a urine bag inserted into their bladder during the recovery period.

Laser

Laser Resection of the Prostate

TURP may be performed with a laser in procedures called photoselective vaporization of the prostate (PVP) or holmium laser enucleation (HOLEP). Laser therapy lessens the bleeding risks of traditional TURP. However, since prostate tissue is still removed, there can be tissue swelling and an uncomfortable healing time. Typically, a catheter has to be inserted into the bladder after the procedure.

Surgery

Transurethral Resection of the Prostate (TURP)

TURP is the most common surgery to treat BPH. During this procedure, patients undergo general anesthesia, and prostate tissue is removed. TURP is often considered the “gold standard” for long-term results.

After prostate tissue has been removed, the body needs time to heal. The remaining prostate tissue may actually swell and become inflamed before the desired shrinking effect occurs. Patients may suffer an uncomfortable recovery period that includes short-term problems
such as bleeding, infection, erectile dysfunction, and urinary incontinence. Patients have to
have a catheter that is attached to a urine bag inserted into their bladder for several days after the procedure.

Symptom relief may not occur immediately, but lasts for a long time in many patients once it does occur.

There can be long-term side effects after TURP such as dry orgasm (retrograde ejaculation), erectile dysfunction or incontinence (leaking of urine).

  1. NeoTract US market model estimates for 2016 based on IMS Health and Drug Procedure Data

UroLift® System Frequently Asked Questions

1. What is the UroLift® System?

The UroLift® System is a new minimally invasive treatment designed to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

2. How does the UroLift System work?

The UroLift System consists of a delivery device and tiny permanent implants. FDA cleared in 2013, this unique technology works by directly opening the urethra with tiny implants that hold the enlarged tissue out of the way, like tiebacks on a window curtain. No cutting, heating, or ablating tissue is involved, making the UroLift System the first and only BPH treatment that does not remove prostate tissue and does not negatively impact a man’s sexual function.

3. How do I know if the UroLift System treatment is right for me?

The UroLift System is a proven treatment option for BPH patients who are looking for an alternative to drugs or major surgery. You may be considering or scheduled for a TURP/Laser treatment, or are unhappy with or have stopped taking medications. The UroLift System is appropriate for patients seeking a minimally invasive treatment and are concerned about preserving their sexual function and their quality of life.

4. What should I expect during the UroLift System treatment?

If you and your doctor decide that the UroLift System treatment is right for you, your doctor will provide the specific, detailed information relating to your condition. 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 may be performed under local or general anesthesia and you may be given medication to feel comfortable during the treatment. Typically, no catheter and no overnight stay is required post-treatment.

5. What happens post-treatment, during the recovery period?

After the treatment, almost all patients 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 light 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.

6. Will having the UroLift System treatment affect my sexual function?

Sexual function has been preserved among the hundreds of patients treated in our clinical studies.1,2,3,4 This is a unique benefit of the UroLift System treatment compared with other BPH therapies such as TURP, laser, and even medication.

7. Is the treatment permanent?

The UroLift Implant is a permanent implant, and the treatment is intended to be permanent. Durability has been shown to at least 4 years in U.S. clinical data,1 and results will continue to be published as follow-ups continue. One unique aspect of the UroLift System is that it does not preclude retreatment or other BPH treatments, should that be needed and desired in the future.

8. What happens if the implants need to be removed?

The implant is made up of standard surgical implantable materials: a nitinol capsular tab, a stainless steel urethral tab, and polyester suture that holds the two tabs together. Your doctor can simply remove the implant, if needed. The suture can be cut and the urethral endpiece can be retrieved with a standard grasper. The capsular tab will remain outside the prostate capsule in place.

9. Are there any contraindications?

The primary contraindications are an obstructive or protruding median lobe of the prostate and a prostate with a volume of >80cc.

10. Will the implants interfere with having an MRI?

Non-clinical testing has demonstrated that the UroLift Implant is MR Conditional. That means that you can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 3 Tesla or less
  • Maximum spatial gradient magnetic field of 1500 Gauss/cm (15 T/m) or less
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg (First Level Controlled 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.

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 Tesla MRI system.

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.

11. Will the UroLift implants affect a digital rectal exam (DRE)?

No. 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. The implants are not expected to interfere in a DRE.

12. What clinical data is available for the UroLift System?

Over 950 patient-years of clinical data has been presented in peer-reviewed publications to date demonstrating that the UroLift System is safe and effective. Clinical studies have been conducted in the United States, Canada, Europe and Australia.

13. How do I find out if my health plan covers the UroLift System treatment?

The first step is to make an appointment with your urologist to determine if you
are an appropriate candidate for the treatment. Your physician’s office staff can work with you and your health plan to learn more about your healthcare benefits specific to the UroLift implant procedure.

14. Does Medicare cover the UroLift System?

Yes, all Medicare arriers provide benefits for the UroLift System when medically necessary. Discuss the UroLift System with your physician to determine if the UroLift treatment is an option for you.

15. 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. The urologist completes comprehensive training prior to using the UroLift System. Find a UroLift System doctor.

16. Where is the UroLift System available?

The UroLift System is available for sale in the United States, Europe, Canada and Australia.

17. Who manufactures the UroLift System?

NeoTract, Inc. manufactures the UroLift System. The company is based in Pleasanton, California.

  1. Roehrborn 2016 Urology Clinics
  2. Roehrborn, 2015 Canadian Journal of Urology, 3-Year Results L.I.F.T. Study
  3. Roehrborn, 2013 Journal of Urology, L.I.F.T Study
  4. McVary, 2014 Journal of Sexual Medicine, Preservation of sexual function with the prostatic urethral lift

Talking to Your Doctor About BPH

BPH is a very common condition and is one of the leading reasons for men to visit a urologist. Whether you have just started experiencing symptoms or if you’ve tried various medications or even surgery, there are a range of treatment options available.

Before you visit the doctor’s office, you can take this BPH Symptom Quiz, designed by the American Urological Association, to determine the severity of your symptoms. We will discuss your symptoms together to decide which treatment option is best for you.

Schedule an appointment today to discuss your BPH symptoms with us.