Letter: BPH guidelines may ignore FDA, insurance criteria
"As we seek to understand MIST retreatment rates, as Houlihan and Köhler suggest, we must rely upon real-world population data," writes Gregg Eure, MD, in a letter to the editor.
To the editor:
In the March 2020 Urology Times®, Houlihan and Köhler present an excellent review of key aspects of the 2019 AUA BPH guidelines update (“Updated AUA BPH guidelines: What you need to know about pre-procedure evaluation, novel surgical enhancements,” March 2020, page 1). Badlani further emphasizes that the guidelines point to the need for a more thorough understanding of each individual patient’s desires and values when reaching the best shared decision on treatment of choice (“Alternatives to TURP: Consider these variables,” March 2020, page 5). Treatment options indeed offer different levels of trade-off between effectiveness and adverse effects.
When considering the AUA guidelines, it is important to realize where they fit in the available evidence for treatments. This recent AUA guidelines update required that all evidence be from randomized controlled trials, ideally comparing new treatments to TURP, the presumptive gold standard. This methodology certainly assures that only the highest level of evidence is considered, but it also can cause the guidelines to ignore important evidence of lower scientific quality that often supports FDA indications and insurance criteria. In the Urology Times® article “De-MISTifying less-invasive solutions for BPH” (March 2020, page 22), Kaplan discusses the importance of weighing not only efficacy (high-level evidence in highly controlled populations, e.g. guidelines) but also effectiveness (lower level evidence in the larger, real-life clinical populations). The former tells us if a treatment option can work in controlled conditions, while the latter tells us if it works in the real world.
Focusing solely on efficacy can lead to discrepancies between guidelines and regulatory bodies. For instance, Houlihan and Köhler state that the AUA guidelines recommend the Prostatic Urethral Lift (PUL) procedure for prostates no larger than 80 grams [they actually misquote the guidelines as “30-80 grams”; there is no lower limit on prostate volume] and absence of a median lobe. Importantly, the current FDA indication for PUL is for prostates up to 100 grams with no volume lower limit. In addition, the FDA indication includes treatment of median lobe hyperplasia. The evidence that convinced the FDA to broaden the indication is based on nonrandomized studies1,2 that did not meet the BPH guidelines rubric for assessment.
A perhaps more alarming example is the guidelines recommendation for RezÅ«m steam treatment “for prostates <80 grams [no volume lower limit],” while the FDA and many insurers explicitly contraindicate prostates below 30 grams. With regard to upper limits of prostate volume, the WATER II study reported on Aquabeam for prostates 80-150 grams; this too will not meet the guidelines rubric for assessment,3 though it provides important information on efficacy and safety for these patients.
As mentioned by Houlihan and Köhler and later emphasized by Badlani, preservation of sexual function can be an important driver in treatment choice for our patients. With ejaculatory dysfunction ranging from 4%-24% for tamsulosin and up to 28% for silodosin, there are many men who might consider minimally invasive surgical therapy (MIST) over alpha-blockers. It is therefore imperative that we dive a bit deeper than “sexual function preserving” as a tag line and distinguish to what level sexual function is preserved.
The randomized evidence for Aquabeam showed preservation of ejaculatory function that was better than transurethral resection of the prostate (TURP), but not ideal. Sustained anejaculation was 11.3% vs 36.4% for TURP. Transurethral incision of the prostate (TUIP) is efficacious for prostates under 30 grams but is associated with up to a 20% anejaculation rate. Rezūm showed no meaningful reduction in overall mean MSHQ-EjD score but did have a 3.1% incidence of anejaculation, and larger nonrandomized studies showed this as high as 20%.4 Only PUL has shown in two randomized studies 0% new-onset, sustained anejaculation, further corroborated by effectiveness real-world data.
It is particularly important as we evaluate MIST options with our patients that we understand not only how each treats lower urinary tract symptoms but also how they address MIST goals: preserving sexual function, avoiding postoperative catheter and associated infection, and whether the procedure can be delivered in an office.
Surgical retreatment rates are specifically available in efficacy studies, yet reporting on postoperative BPH medication usage is unreliable, and loss to follow-up can be high. For true overall retreatment rates, we must rely upon population studies, rather than prospective studies, as has been done with TURP. While Houlihan and Köhler give a guidelines update, they rely upon a Canadian population effectiveness study, which by its very nature would be outside of the guidelines update, to discuss how modern-day TURP performs, namely with lower transfusion rate, higher stricture rate, and higher retreatment than in past studies.
These same authors, in a different publication, report post-TURP usage of alpha-blockers and 5-alpha-reductase inhibitors at 27% and 20%, similar to the high rates found in other population studies conducted in the United States and France.5 As we seek to understand MIST retreatment rates, as Houlihan and Köhler suggest, we must rely upon real-world population data.
Gregg Eure, MD
Virginia Beach, Virginia
1. Rukstalis D, Grier D, Stroup SP, et al. Prostatic Urethral Lift (PUL) for obstructive median lobes: 12 month results of the MedLift Study.Prostate Cancer Prostatic Dis. 2019:22(3):411-419. doi: 10.1038/s41391-018-0118-x.
2. Eure G, Gange S, Walter P, et al. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study.J Endourol 2019;33(7):576-584. doi: 10.1089/end.2019.0167.
3. Desai M, Bidair M, Zorn KC, et al. Aquablation for benign prostatic hyperplasia in large prostates (80-150 mL): 6-month results from the WATER II trial.BJU Int 2019;124(2):321-328. doi: 10.1111/bju.14703.
4. Avant RA, Gopalakrishna A, Helo S, et al. Prevalence of Ejaculatory Dysfunction Following Rezūm Prostate Ablation. World Congress of Endourology proceedings 2018, abstract, UP3-33. Accessed May 11, 2020. https://www.eventscribe.com/2018/WCE2018/PosterTitles.asp?goToLetter=P&h=Browse%20By%20Title&BCFO=US.
5. Campbell J, Reid J, Ordon M, Welk B. The Utilization of Benign Prostatic Hyperplasia and Bladder-Related Medications After a Transurethral Prostatectomy. Urology. 2019;130:126-131. doi: 10.1016/j.urology.2019.05.003.
The authors respond:
The authors regret misquoting the AUA guidelines pertaining to Prostatic Urethral Lift as being for use in prostates 30-80 grams when in fact there is no lower prostate volume limit for this procedure.
Matthew D. Houlihan, DO, and Tobias S. Köhler, MD, MPH
Rochester, Minnesota
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