The prevalence of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia in men older than 50, the side effects of available pharmacologic treatments, and the degree of morbidity associated with surgical resection or ablation have spurred the search for alternate therapies.
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The recent introduction of the prostatic urethral lift procedure, marketed as the UroLift® System, provides a minimally invasive approach to treating the enlarged prostate. The procedure uses a series of anchored permanent implants to reshape the prostate and relieve urethral constriction without resecting or vaporizing tissue.
In this question-and-answer session, urologist James Ulchaker, MD, of Cleveland Clinic’s Glickman Urological & Kidney Institute discusses the procedure.
Q What is UroLift and why is its development significant?
UroLift is a minimally invasive treatment option performed in the office setting under a local anesthetic for the treatment of benign prostatic hyperplasia.
It was cleared for marketing by the Food and Drug Administration in September 2013. It received a Category 1 Current Procedural Technology (CPT) coding on Jan. 1, 2015, which means that it has its own code for medical billing purposes.
It is significant because as more and more treatments are desired to be performed in a minimally invasive setting whenever possible, for properly selected patients UroLift gives the opportunity for a single, one-time-only office-based procedure to be performed instead of patients taking one or at times multiple drugs daily for the foreseeable future.
Q How do you decide whether UroLift is the appropriate treatment as opposed to medications or more invasive surgery?
We do a standard workup which involves three outpatient tests. The first is urodynamics, which is used to determine how well the patient’s bladder stores urine and how well it is able to contract to expel urine. It also gives us a real-time analysis of the patient’s average and maximum flow, how much urine remains in the bladder after voiding, and the pressure generated by the bladder in both the storage and voiding phases. The second test is cystoscopy, where we pass a flexible tube using a local anesthetic, traversing the urethra and prostate and into the bladder for visual inspection. That helps us determine whether the problem is actually prostatic in nature or from some other source such as a urethral stricture, a bladder stone, a tumor or other causes of lower urinary tract symptoms. Cystoscopy also allows us to determine the type of prostatic growth that is present – whether it is bi-lobar, tri-lobar, or whether there is any intravesicle extension of prostate tissue growing or pushing into the bladder. The last test we do is trans-rectal ultrasound, to determine the size of the prostate, because we will treat a 40-gram prostate differently than an 80-gram prostate or a 180-gram prostate. Various treatment options are going to be open or closed to the patient depending on the size and anatomy of the prostate.
Q When would it be appropriate to use UroLift?
It can be done as long as the patient has at least some bladder contraction present, a prostate size of 80 grams or less, and bi-lobar hypertrophy. We cannot do UroLift if growth is coming from the bottom.
UroLift is just one option for BPH patients. Some may choose medication. Some may choose transurethral resection of the prostate (TURP), or electro- or laser vaporization of prostate tissue. UroLift’s advantage is that it does not need to be done in the operating room; it can be done in the office without a general or spinal anesthetic.
The efficacy is not as good as TURP and it’s not meant to be. UroLift is a procedure designed to alleviate BPH symptoms but it is not going to result in the same urine flow rate. The surgical procedures done in the operating room are better in terms of the degree of symptom relief, but are not appropriate or necessary for every patient. This is a quality of life issue. When we complete the work-up, we discuss our findings and review the treatment options with the patient, who makes the final decision.
Q What is the UroLift implantation process?
We use a hospital outpatient procedure room. No oral or IV medications or sedation is administered. We first give a prostate block, trans-rectally injecting lidocaine peri-prostatically. We then reposition the patient and use lidocaine jelly to numb the urethra. Once the patient is properly blocked we pass the UroLift delivery device through the obstructed urethra using cystoscopic guidance. Most prostates require four implants. The implants consist of a nitinol capsular tab, a retractable PET suture and a stainless steel urethral end piece. We place the implants essentially at the 2 and 10 o’clock positions of the prostate to mechanically lift and separate the obstructing tissue. Once numbing occurs, the implantation procedure takes only a few minutes.
Q What is recovery like?
We normally do not leave a catheter post-procedure. The patient can drive to and from the procedure since no general anesthesia is used. Due to the lifting and separating effects of the implants, the patient typically experiences improved urination almost immediately. Recently presented clinical trial results show that improvement in lower urinary tract symptoms secondary to BPH is durable to four years.
Q Are there any potential complications?
Yes. We give preoperative antibiotics in an effort to prevent urinary tract infections due to urethral manipulation. Also, there is always a concern of encrustation or stone formation on the implant’s stainless steel urethral end piece. To date we have seen none. If the implants are properly placed, patients should have little to no incontinence and little to no retrograde ejaculation, which are two complications that commonly occur following other BPH surgical procedures. That’s because with UroLift the bladder neck and urethral sphincter are left intact.
The other thing is that if a patient is not satisfied with the UroLift procedure, it doesn’t preclude having another procedure. You can always go on to more invasive procedures. The implants are permanent, but if you have TURP, the electric current basically cuts through the PET suture, leaving the capsular tab in place.
Q What is Cleveland Clinic’s experience with UroLift?
Our first procedure was in September 2015. Early outcomes have revealed high levels of patient satisfaction with the procedure itself and with its results. The biggest problem we have in getting the procedure performed is that a number of insurance companies and certain Medicare providers still look at this as being experimental and will not pay for it. Even though it is FDA-approved and has its own CPT code, some payers are reluctant to reimburse for it until additional data comes out. I expect that will change depending on the outcome of ongoing research.