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 new 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. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. Your doctor will discuss with you how quickly you can return to your normal physical activities.
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. 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 3 years in U.S. clinical data, 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?
The UroLift® Implant is MR Conditional. It can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 Tesla or 3.0 Tesla or less, only
• Maximum spatial gradient magnetic field of 1,500 Gauss/cm (15 T/m) (extrapolated) or less
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg for 15 minutes of scanning (i.e per pulse sequence) (First Level Controlled Mode)
Under the scan conditions defined above, the UroLift Implant is expected to produce a maximum temperature rise of 2.2°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.
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 600 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. To learn more about the clinical data available, visit our Publications page.
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?
Some Medicare carriers are covering the UroLift System treatment
and some are not. Others are determining coverage on a case by case basis. Your physician’s office staff can provide more information. If your UroLift System treatment claim is denied by Medicare, you have the right to appeal; your physician’s office may appeal the decision on your behalf. Please discuss this potential option with your physician.
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.