Patient Safety

What is The UroLift^® System used for? (Indications for Use)

The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH), including lateral and median lobe hyperplasia, in men 45 years of age or older.

Are there any reasons why I should not receive a UroLift System procedure?

The UroLift System should not be used if you have:

Prostate volume of >100 cc
A urinary tract infection
Urethra conditions that may prevent insertion of delivery system into bladder
Urinary incontinence due to incompetent sphincter
Current gross hematuria
If you have a known allergy to nickel, titanium, or stainless steel, talk to your doctor about your allergy before getting a UroLift System procedure

What other things should my doctor advise me about?

Most patients do not typically require a catheter post-procedure, but it is possible that you may. If needed, the catheter typically only stays in for an average of about one day.

Recovery times vary but patients typically experience rapid symptom relief and a return to normal activity within a few days. Your doctor will discuss any restrictions in your specific situation.

What are the most common side effects?

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.1 Rare side effects, including bleeding and infection, may lead to a serious outcome and may require intervention.

In the large, pivotal study, there were no reported instances of new, sustained erectile or ejaculatory dysfunction following a UroLift System procedure.2-4

See the UroLift System Instructions for Use for more information.

Will the UroLift System Procedure 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 3.0 Tesla or less
Maximum spatial gradient magnetic field of 1500 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 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 2.4°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

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.