Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas and co-principal investigator for the L.I.F.T. clinical program, detailed findings from the largest, prospective, multi-center, randomized, controlled trial on the minimally invasive PUL to date at the 2017 American Urological Association Annual meeting, in Boston, May 12-16.
Conducted between February and December of 2011, the assessment involved 19 centers in North America and Australia, from which investigators randomized men with symptomatic LUTS secondary to benign prostatic hyperplasia (BPH) to PUL (N=140) or sham control (N=66). Enrollment criteria included age ≥ 50 years, IPSS (International Prostate Symptom Score) ≥ 13, peak flow rate ≤ 12 ml/s, and prostate volume 30 - 80 cc. Through 3 months, patients and assessors were kept blinded to treatment arm. Assessments for PUL subjects continued through 5 years with validated instruments including IPSS, IPSS quality of life (QoL), BPH Impact Index, Qmax, Sexual Health Inventory for Men, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction.
The study demonstrated that the average symptom score improved for PUL patients by 1 month (IPSS: 44% and QoL: 42%, p<0.001) and remained improved through 5 years (IPSS: 38% and QoL: 54%, p<0.001). Peak flow rate remained improved 41% at 5 years. Adverse events such as hematuria, dysuria, pelvic pain, urgency and urge incontinence were typically mild and transient. There was no occurrence of de novo, sustained erectile or ejaculatory dysfunction. Sexual function was preserved in the PUL cohort, as assessments show stable erectile function average score and improved ejaculatory function and ejaculatory bother average scores (p<0.001).
Dr. Roehrborn and co-investigators concluded that the 5-year data from this large and prolonged study of the PUL procedure indicates that symptom relief and quality of life improvements can be durably sustained to 5 years. In addition, sexual function was preserved in subjects, both in terms of erection and ejaculation.
Speaking with Urotoday at the American Urological Association (AUA) annual meeting in Boston, May 12-16, Dr. Roehrborn elaborated on the findings and the promise of PUL.
Q: Dr. Roehrborn, could you briefly describe this newer endoscopic method for treating BPH?
A: The UroLift procedure is really not all that new, but at this year’s American Urological Association meeting (AUA), the randomized sham controlled study, has reached its 5-year endpoint that was requested by the FDA and a pre-condition to approval. So, it’s not all that new, but has now reached maturity. In the field of BPH, a device that has proven durability over 5 years can be safely said to have reached maturity.
This treatment is an innovative, endoscopic, outpatient procedure that can be done in the office or in a day surgery center, or, if desired, in the operating room. It can be done under local anesthesia or under propofol sedation, or under spinal general, as desired. It is important to note that it is truly outpatient feasible with local anesthetic only.
“It is important to note that it [PUL] is truly outpatient-feasible with local anesthetic only.”PUL is a mechanical treatment. It is important to note that is does not involve heat—it does not involve thermal energy. It does not involve electric, or laser removal of tissue. The mechanism of action of the Urolift [involves] use of the device to compress the lateral lobes of the prostate tissue outward against the capsule of the prostate by way of a double-anchor device connected with a suture tab, and by placing the Urolift device from the bladder neck into the prostatic urethra. aggressively, opening the urethra and widening that channel to allow improved urination flow.
Dr. Claus Roehrborn, UT Southwestern Medical Center
It’s innovative and new because it is currently the only treatment for BPH that is purely mechanical: it does not require any heat, energy laser, cautery, or any such thing.
In the pivotal study, in 99% of patients, the treatment has been done with local anesthetic. Eighty percent of the patients did not require a catheter following the procedure. And, after a week, the patients were back to full, total normal activity. So, it’s really a minimally invasive outpatient procedure in the true sense of the word.
Q: You have described the advantages of the Urolift device as ease of mastery, a short learning curve, and the convenience of use in an office setting. Could you comment further on the ease of mastery of the procedure?
A: All of the procedures in urology and any other specialty require some training and some familiarity: there is no doubt about it. This one has been studied in several large series. One is the pivotal randomized trial in which over 200 patients were enrolled and treated in19 centers by 19 different investigators. Another one is a study in Europe where about a dozen investigators were using it. And then there were other clinical series.
What is remarkable is that in each of these studies, the investigators were new to the technology: they had not done it before. So, for each one, the patients who were treated on the study were their first patients—five patients or 10 patients, depending on how many they enrolled.
When you lay these improvement curves of symptoms upon each other and over each other, you realize that it doesn’t matter who did [the procedure], where it was done—what continent, what country—when it was done, the sequence: the patients all received the same improvement of symptoms. This suggests that most urologists familiar with endoscopic approaches to the urinary tract will rather quickly master the technique and apply it to its fullest benefit. That’s what these data suggest.
If somebody would ask me about the “learning curve”, I would say that just to master the technique, it’s probably less than 5 procedures.
There is a little bit more to the art of patient selection, to avoid pitfalls such as inappropriate gland sizes or shapes. But it is not a long learning curve, as these data suggest.
Q: What patients might be ruled out?
A: This device is uniquely suitable for patients who have lateral lobe hyperplasia of the prostate and obstruction as a result of this. It is less suitable for patients who have middle lobe, or intravesical lobe, or median lobe hyperplasia, or an intravesical protrusion. Those patients would not benefit from it.
Urologists will have to evaluate patients likely by way of cystoscopy or ultrasound to determine whether a patient is a proper candidate. This is very important to maintain good outcomes because if you administer this treatment to a poorly chosen prostate, the outcome is not as good.
It’s also important that the prostate is not too large. The FDA cleared the treatment for prostates up to 80 grams. I myself, in my practice, try to stay between a typical 30 and 80 gram prostate size, which happens to encompass between 80% of all the prostates we treat.
Q: Where do you think this option will ultimately fit within the landscape of treatments for BPH symptoms?
A: I think it fits in really well, because it is truly an alternative in every sense of the word. Patients can choose to ignore their symptoms, which many do. Patients can take medications: some like this and some hate to take medicines. Drugs also have some side effects and limited efficacy. And, patients can choose surgery to remove tissue: like laser, TURP, HOLEP. KTP laser…
In this sense it [PUL] is nice, because it is an alternative that is really quite in the middle because it is truly outpatient. It is not involving any energy, cautery, laser energy. It is [a]short [procedure], usually15-minutes or less, [with a] mechanical device that opens up the prostatic urethra, and allows for symptom improvement by that mechanism.
There is another reasons that it [PUL] fits in so well, because patients have different priorities. For some patients, it is important to get up less often during the night. For other patients, it is important to have less frequency. To some patients – many patients – it is important that their quality of life is undisturbed.
Many patients with BPH are concerned with erection and normal ejaculatory function, to which they are used. Men in their 50s in particular who have voiding symptoms due to their prostate are in general very interested in sexual abilities, including ejaculatory function. This treatment is unique in that it does not affect ejaculatory function. All men maintain normal antegrade with climax, ejaculatory function and normal erections. I think it fits in really well, because it is truly an alternative in every sense of the word.
We are used to saying that that the lowest risk [interventions] are the medications. Then come these minimally invasive treatments. And then comes surgery. As the risk increases, so does the efficacy. The Urolift is in the middle in terms of efficacy, but actually, if you take Flomax, or rapaflow, or dutasteride, or Avodart, you have a higher risk of incurring sexual side effects [than with Urolift].
This old idea of an increase in complications with an increase in efficacy does not completely work here. The Urolift actually prevents sexual complications, and has greater efficacy than the drugs. So, many patients find this an attractive solution, even without starting drugs.
Q: What may any shortcomings, or pushbacks, with the Urolift device that patients or clinicians cite?
A: [While] 5-Fu-data are good, after 5 years there are about 2-3% of patients per year who will require a retreatment. This is one substantial criticism of all of these treatments. The retreatment rate of a well-done TUR prostate should be about 1-2%. The retreatment rate here is more [in the neighborhood of] 2-3%. That is one pushback.
The other pushback with this device is its upfront cost. So, when you take a drug, the co-pay could be $10. You could try it for a month, then stop [if it doesn’t work]. The cost of the Urolift [is higher], and is all upfront. When we look at cost-effectiveness models, there is always a bit of a tradeoff. People make this point, and currently so.
And then, patients will have to set aside a half day to go to the doctor’s office for the procedure. Then, he can’t play tennis or golf, or go to the gym that week. With the Urolift, in studies that have been published with this device, the return to fully normal activities has been reported to range from 5 to 8 days.
Q: Are patients reporting that they are a bit afraid of a quasi-surgical procedure, versus just managing along with drug therapy?
A: I wouldn’t say that patients are afraid, in a sense, but it is clearly a greater hurdle. The easiest hurdle is for a man to say: “I get up three times at night, and maybe my treatment is not that good, and I have to pee frequently, but I just ignore it.” The second hurdle is: a man goes to a store and finds a prostate supplement for $20.
Or, a man may go to a doctor and report symptoms, and he may do things that are unpleasant. He may want to do testing or even a cystoscopy, and write a prescription. For men with this condition of BPH, the easiest thing to do is to ignore it. The second easiest is to go to a pharmacy or health food store for a supplement, despite the evidence that these things don’t do anything.