This news release was remarkably short on details and long on promise about an apparently new method to treat benign prostatic hyperplasia (BPH) in men. Sadly this was a missed opportunity to educate readers about how the surgery was studied and how it compares to the other common methods to treat enlarged prostates — including competing minimally invasive approaches. Promotional language describing this procedure as a “breakthrough” and “first line option” isn’t backed up by evidence.
[Editors note: Our rating for the ‘harms’ criterion of this review has been changed to Not Satisfactory and the star score decreased from two stars to one star. See below for an explanation.]
If this minimally invasive surgery to relieve the symptoms of BPH was supported by solid comparative evidence of the procedure’s benefits and harms, it could indeed be an advance for men suffering from this condition. A lot of unanswered questions emerge from this news release: How was the procedure studied? How did it compare to alternative treatments? How did it compare in terms of benefits and harms? And how much does it cost?
There was no discussion of the costs of the procedure or the patented system used, nor of the downstream costs associated with recovery from the procedure. There was also no data on how long patients were followed and how many required a repeat intervention–either repeat UroLift or other invasive treatment. This outcome has implications for both costs and effectiveness.
We learn that “data from clinical trials showed that patients receiving UroLift implants reported rapid symptomatic improvement, improved urinary flow rates, and sustained sexual function. Patients also experienced a significant improvement in quality of life.” All is good, but what was the magnitude of benefits and, more importantly, “compared to what”?
We learn about a range of adverse effects ranging from blood in the urine to incontinence. “Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure,” we are told.
We’ll award a satisfactory grade here because the release at least mentions some adverse effects associated with the procedure. But as with the benefits description, we again receive no sense of what this is compared to (drugs? surgery? watchful waiting?), how common these problems were, or what the release means when it describes them as “mild to moderate in severity.”
Update: This rating has been changed to Not Satisfactory in order to be consistent with how this criterion has been applied in the past. As stated in the description of our review criteria, a news release or story may be rated Not Satisfactory if it:
This is not satisfactory because even though we are told the “UroLift System has an excellent safety profile and provides men suffering from an enlarged prostate a beneficial first-line treatment alternative to drug therapy or more invasive surgery,” we are left with a complete absence of information related to the quality of the research that underlies these assertions. If the UroLift System “provides fast and meaningful relief from BPH symptoms, improving overall quality of life for our patients,” we need more than ‘trust us, we’re experts’ assertions. We need to know long-term (at least 1 year) comparative effectiveness and safety data compared to medical therapy, “more” invasive surgery, and the numerous available minimally invasive procedures that treat this condition.
While the release doesn’t disease-monger, it could have been more informative — for example by accurately describing how severe/bothersome the symptoms were for patients treated with this device.
The release is silent on issues related to conflict of interest. The studies cited in the release were funded by the device manufacturer. The Northwestern urologist quoted in the release has received small payments (amounting to $121.50) from the manufacturer for food and beverages. These could have been acknowledged in a footnote.
We learn that there are some alternatives (drugs and surgery), but we aren’t told that there are numerous other minimally invasive procedures available–laser treatments, microwave thermotherapy, radiofrequency ablation, vaporization, etc. The release is overly dismissive of drug therapy, which has been shown to be effective, well tolerated, and safe. Pushing this treatment as a first line treatment is inappropriate–and the absence of data from head-to-head trials with either other minimally invasive procedures or the gold standard (transurethral resection of the prostate or TURP) means that the relative value of the new technology is quite uncertain.
The FDA “cleared” this surgical implant system in 2013 and it is available at Northwestern University, but there are no details about its general availability in other regions or health systems. We are left wondering.
The release offers some details on how this system is different from drugs and other surgical type treatments, so this merits a passing grade.
The description is mostly free of unjustified language, except for the headline, which uses one of the 7 words you shouldn’t use in medical news: “breakthrough.” Is it proper to call something a “new breakthrough” when it has apparently been on the market for four years? And when its effectiveness compared with other approaches hasn’t been properly established?