UROLIFT®

Benign prostatic hyperplasia, or BPH, is a condition that results in an enlarged prostate gland. BPH can lead to various bothersome urinary symptoms due to the prostate pressing against the urethra, the tube through which urine exits the body. While BPH is not typically dangerous, it can significantly impact quality of life if left untreated

Not sure how to know if you have an enlarged prostate? You may want to seek 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
• Sensation that the bladder is not empty after urinating
• Weak urine flow
• Increased frequency of urination and frequent nighttime urination
• Pain or burning sensation during urination.

If you’re experiencing these symptoms, it’s best to discuss BPH surgery options with your doctor to determine which treatment is right for you.

If left untreated, BPH can lead to permanent bladder damage. When the bladder does not empty completely, the risk of developing urinary tract infections (UTIs) may increase. Other serious problems can also develop over time, including bladder stones, blood in the urine, incontinence, or urinary retention.

No, BPH (Benign Prostatic Hyperplasia) is a benign condition and unrelated to prostate cancer; however, it can greatly affect a man’s quality of life. BPH is NOT a type of cancer.

The FDA-cleared UroLift System is a relatively new treatment for BPH, and it’s 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 FDA-cleared UroLift System is the only treatment that uses the Prostatic Urethral Lift (PUL) procedure. UroLift for prostate issues 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 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 tiny 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. The Implants are delivered through a small needle that comes out of the delivery device and into the prostate.
• The UroLift Device is removed, leaving an open urethra that provides symptom relief.

One unique aspect of the UroLift System is that it does not preclude retreatment or BPH treatments such as TURP or laser, should they be required in the future.

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.

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.

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.

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.

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

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.

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.

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.

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.

Yes, all Medicare carriers 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.

UroLift is a safe, minimally invasive solution for treating BPH. By helping reduce obstructive prostate tissue, UroLift can help relieve symptoms of BPH without interfering with sexual function. Side effects are minimal and the procedure is quick to complete.

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.

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

Source: ​https://www.urolift.com/patients/getting-started/patient-resources/faqs.html

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

Typically performed under general or local anesthesia for an outpatient procedure, UroLift recovery is a relatively fast process. You’ll need to stay home and rest for two to three days after the procedure. During this time, you may experience a burning sensation or blood in your urine, but this will subside as you heal. You’ll also need to avoid intense exercise, sexual intercourse, and other strenuous activities for two to three days after the procedure.