Topic: BPH

Saw Palmetto for BPH, Prostate Cancer, or Prostatitis?

J. Curtis Nickel, MD, FRCSC, the Canada Research Chair in Urologic Pain and Inflammation and Professor of Urology at Queen’s University in Kingston, Ontario, discusses research on the herbal medicine saw palmetto and its efficacy as an alternative therapy for benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS), prostatitis, and prostate cancer. He relates the history of saw palmetto, explaining that it has been used to treat urinary problems for centuries, but fell out of widespread use in North America at the start of the the modern pharmaceutical era in the 1920s, though physicians in Europe continued prescribing it. Dr. Nickel notes that there are two primary forms of saw palmetto products in North America: saw palmetto extract, which is high in fatty acids; and saw palmetto ground berry powder, which is low in fatty acids. Dr. Nickel emphasizes that the presence of fatty acids is important since prostate cells preferentially take up fatty acids and sterols. He highlights the difference between the North American guidelines, which state that “the available data do not suggest that saw palmetto has a clinically meaningful effect on LUTS secondary to BPH,” and the European guidelines which recommend using saw palmetto on the “basis of its long-standing use.” Dr. Nickel then considers the evidence, explaining that a literature review of 1575 research publications on saw palmetto and LUTS indicates saw palmetto extracts are safe, improve symptoms, and improve quality of life. He then looks at the potential role of saw palmetto in treating prostatitis, a prevalent condition in North American men. Dr. Nickel explains that until recently, researchers could not find evidence from randomized placebo-controlled trials to substantiate findings that the hexanic extract of saw palmetto reduces prostate inflammation. However, he notes, a recent trial suggests saw palmetto extract is effective, safe, and clinically superior to placebo for the treatment of chronic prostatitis/chronic pelvic pain syndrome. Dr. Nickel then turns to the question of whether or not saw palmetto could have a role in managing prostate cancer. He explains that saw palmetto seems like it could have value in preventing or managing prostate cancer since it antagonizes 5ɑ-reductase to reduce DHT production, inhibits DHT binding to androgen receptors, inhibits the expression of Cox-2, inhibits prostate cell growth, etc. However, studies have not found any association between use of saw palmetto and risk of prostate cancer development, nor any correlation with increasing frequency or duration of use. Dr. Nickel concludes that saw palmetto extract is a valuable alternative therapy for men with mild to moderate LUTS/BPH, that it is potentially a useful alternative therapy for prostatitis, and that it does not play a role in prostate cancer prevention or treatment in 2022.

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Treating BPH: Comparing Treatment Modalities

Michael E. Albo, MD, Vice Chair of the Department of Urology at the University of California, San Diego, compares the efficacy, safety, and considerations for a variety of treatment options—both traditional surgical and newer, minimally-invasive therapies—for patients with benign prostatic hyperplasia (BPH) causing lower urinary tract symptoms (LUTS). He begins by outlining the surgical management of LUTS attributed to BPH before discussing the goals and selection of treatment. He explains the patient and urologist perspectives in terms of evaluating minimally invasive therapies before summarizing the various treatment options as a whole. The first are resection treatments, including transurethral resection of the prostate (TURP) (which Dr. Albo calls “the gold standard”) and transurethral incision of the prostate (TUIP). Next he describes enucleation technologies, including simple prostatectomy, laser enucleation of the prostate (using holmium [HoLEP] or thulium [ThuLEP] lasers), and bipolar enucleation. Dr. Albo explains that while simple prostatectomy should be considered only for patients with large to very large prostates, laser enucleation options are size-independent options for the treatment of LUTs/BPH; additionally, the HoLEP and ThuLEP options have more favorable perioperative safety and he advises these be considered as treatment options in patients at higher risk of bleeding. Dr. Albo then addresses vaporization procedures, including bipolar transurethral vaporization of the prostate (TUVP) and photoselective laser vaporization of the prostate (PVP), explaining that PVP is likely safe for patients on anticoagulants. At this juncture he turns to the minimally-invasive prostatic urethral lift (PUL), citing studies showing this is less effective than TURP but with similar quality of life improvements. Dr. Albo makes the point that trials need to better evaluate minimally invasive interventions in terms of whether patients are able to discontinue medication and therefore whether that intervention can be considered successful. He discusses water vapor thermal therapy (WVTT), citing data supporting the preservation of erectile and ejaculatory function and five-year data showing sustained changes in International Prostate Symptom Score (IPSS) and Qmax. Robotic waterjet treatment (RWT) has been shown to be effective and safe, with the main drawback being bleeding; Dr. Albo predicts that, while more needs to be learned as far as RWT for larger prostates, this procedure could be game-changing. He mentions two additional procedures, transurethral microwave therapy (TUMT) and prostate artery embolization (PAE) (which currently is not recommended outside the context of clinical trials) as well as an investigational treatment with nitinol struts to remodel the bladder neck. He concludes by asserting that the field has come a long way in terms of the sophistication of the surgical treatment algorithm, emphasizing the importance of a discussion with the patient in terms of side effects, the availability of technology at the institution, and the surgeon’s skill level in the decision-making process.

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Saw Palmetto and BPH – Past, Present, and Future

After an introduction from E. David Crawford, MD, Professor of Urology at the University of California, San Diego, and Editor-in Chief of Grand Rounds in Urology, Mark A. Moyad, MD, MPH, the Jenkins/Pokempner Director of Preventive/Complementary and Alternative Medicine (CAM) at the University of Michigan Medical Center in the Department of Urology in Ann Arbor, Michigan, interviews J. Curtis Nickel, MD, FRCSC, the Canada Research Chair in Urologic Pain and Inflammation and Professor of Urology at Queen’s University in Kingston, Ontario, on the history of the herbal medicine saw palmetto and its efficacy as alternative medicine for benign prostatic hyperplasia (BPH). Dr. Moyad observes that in the early 2000s, saw palmetto was widely discussed in North America, but seems to have disappeared from the conversation in recent years. Dr. Nickel explains that while this is true, saw palmetto continues to be developed as a treatment option in Europe. He then notes that the STEP and CAMUS trials were some of the main contributors to North American loss of interest. The 2006 STEP trial failed to prove that saw palmetto had greater efficacy than placebo in BPH by North American medical standards, which Dr. Nickel believes was due to there being different forms and sources of saw palmetto extract and it being difficult to control for which would be used in a study at the time in North America. Dr. Moyad highlights that while this trial may not have found a benefit to saw palmetto, it also found it to be as safe as placebo. Dr. Nickel then goes into further detail about the CAMUS trial, which he worked on, and which was initially based heavily on European studies. However, due to the negative results of the STEP trial, CAMUS was redesigned, and ultimately it too found little difference between saw palmetto and placebo. Dr. Nickel notes that he feels that he and his fellow researchers may have missed something critical in that trial, and ponders why the two North American studies had negative results while so many other trials had positive ones. He also notes that he continues to recommend saw palmetto as an adjunct therapy to many of his patients based on the international literature. Drs. Moyad and Nickel then discuss some of the sourcing difficulties related to saw palmetto, as well as different extraction methods. Dr. Moyad then references Permixon, a European medicinal product derived from saw palmetto, and Dr. Nickel discusses how the way that it is regulated and processed differs from how saw palmetto is handled in North America. Dr. Nickel clarifies that he thinks that saw palmetto is a good alternative treatment for BPH patients looking for less invasive disease management options as long as a USP (US Pharmacopeial Convention)-approved product that is analyzed thoroughly is used.

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Saw Palmetto and BPH – Past, Present, and Future

After an introduction from E. David Crawford, MD, Professor of Urology at the University of California, San Diego, and Editor-in Chief of Grand Rounds in Urology, Mark A. Moyad, MD, MPH, the Jenkins/Pokempner Director of Preventive/Complementary and Alternative Medicine (CAM) at the University of Michigan Medical Center in the Department of Urology in Ann Arbor, Michigan, interviews J. Curtis Nickel, MD, FRCSC, the Canada Research Chair in Urologic Pain and Inflammation and Professor of Urology at Queen’s University in Kingston, Ontario, on the history of the herbal medicine saw palmetto and its efficacy as alternative medicine for benign prostatic hyperplasia (BPH). Dr. Moyad observes that in the early 2000s, saw palmetto was widely discussed in North America, but seems to have disappeared from the conversation in recent years. Dr. Nickel explains that while this is true, saw palmetto continues to be developed as a treatment option in Europe. He then notes that the STEP and CAMUS trials were some of the main contributors to North American loss of interest. The 2006 STEP trial failed to prove that saw palmetto had greater efficacy than placebo in BPH by North American medical standards, which Dr. Nickel believes was due to there being different forms and sources of saw palmetto extract and it being difficult to control for which would be used in a study at the time in North America. Dr. Moyad highlights that while this trial may not have found a benefit to saw palmetto, it also found it to be as safe as placebo. Dr. Nickel then goes into further detail about the CAMUS trial, which he worked on, and which was initially based heavily on European studies. However, due to the negative results of the STEP trial, CAMUS was redesigned, and ultimately it too found little difference between saw palmetto and placebo. Dr. Nickel notes that he feels that he and his fellow researchers may have missed something critical in that trial, and ponders why the two North American studies had negative results while so many other trials had positive ones. He also notes that he continues to recommend saw palmetto as an adjunct therapy to many of his patients based on the international literature. Drs. Moyad and Nickel then discuss some of the sourcing difficulties related to saw palmetto, as well as different extraction methods. Dr. Moyad then references Permixon, a European medicinal product derived from saw palmetto, and Dr. Nickel discusses how the way that it is regulated and processed differs from how saw palmetto is handled in North America. Dr. Nickel clarifies that he thinks that saw palmetto is a good alternative treatment for BPH patients looking for less invasive disease management options as long as a USP (US Pharmacopeial Convention)-approved product that is analyzed thoroughly is used.

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Minimally-Invasive BPH Therapies

Christopher P. Smith, MD, MBA, MSS, Associate Professor of Urology at Baylor College of Medicine in Houston, Texas, considers data on prostatic urethral lift (PUL) and water vapor therapy for benign prostatic hypertrophy (BPH), and analyzes three case studies using the treatments. He begins with an overview of his case studies of men with BPH who all have an International Prostate Symptom Score (IPSS) above 19 and are on tamsulosin but are struggling with the lack of full relief and side effects of the medication. Dr. Smith then discusses the 2021 AUA guidelines for BPH treatment supporting the use of the IPSS at each patient visit to track symptoms and engage patients in early discussions of surgical options in the case of inadequate medications. He continues by summarizing data on the use and efficacy of PUL and water vapor therapy for BPH: a study on the adoption, safety, and retreatment rates of prostatic urethral lift found an increase in the use of the treatment of 10.4% from 2014 to 2018; PUL has passed GreenLight as a preferred procedure as of 2019, accounting for 30% of all BPH procedures; the L.I.F.T. trial and REZUM II trial found that PUL produced significant improvement in symptom scores, quality of life and flow rate when compared to a control; a prospective, randomized, multinational study of PUL versus transurethral resection (TUR) of the prostate found that PUL patients had a more rapid return to baseline activities than TUR patients by 6 days; the MedLift study showed that PUL patients experienced a 75% improvement in IPSS compared to a 34% improvement in control patients; PUL has also been found to have the lowest complications compared to Rezum, TURP, and GreenLight; a study comparing durability predictors after PUL found that men with worse disease states were found to need retreatment at higher rates; PUL is capable of improving ejaculatory function following treatment, while water vapor therapy reduces it; and there has been no recorded difference in outcomes between groups with or without prior prostate surgery. Dr. Smith concludes by stating that all three of his cases were treated with PUL, leading to their IPSS dropping to below 5 and them being taken off of medication.

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Sphincter-Saving Technique in HoLEP Surgery

As part of Grand Rounds in Urology’s ongoing series highlighting urologists working in Asia, Seung-June Oh, MD, PhD, Professor of Urology at Seoul National University in Seoul, South Korea, explains and demonstrates his sphincter-saving technique for holmium laser enucleation of the prostate (HoLEP) surgery. After an introduction by Peter K.F. Chiu, MD, PhD, FRCSEd, Dr. Oh goes over the benefits and difficulties of HoLEP for benign prostatic hyperplasia, emphasizing the problems of post-operative urinary incontinence. He then goes over strategies for maximally preserving the continence mechanism during HoLEP and introduces his Early Inverted V-shaped Apical Mucosal (EVAMI) Technique before showing footage of a routine HoLEP surgery. The presentation concludes with a question and answer session led by Dr. Chiu.

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When All Else Fails: Holmium Laser Enucleation of the Prostate as Retreatment for BPH

Nicole L. Miller, MD, FACS, Associate Professor of Urology at Vanderbilt University Medical Center, discusses Holmium laser enucleation of the prostate (HoLEP), particularly focusing on the retreatment setting. AUA guidelines have recently been updated and now mirror EAU guidelines which suggest sizing a prostate before determining treatment options. Dr. Miller examines case studies that underscore the effectiveness of HoLEP in removing large prostates after the patients had previously undergone unsuccessful treatments, including transurethral resection of the prostate (TURP) and prostatic urethral lift. She then analyzes outcomes of a study that compared primary HoLEP (pHoLEP) to retreatment (rHoLEP) observing that the retreatment setting patients experienced shorter operative times, shorter length of stay, had less tissue resected, and had a higher rate of urethral stricture and clot retention. In spite of its utility, HoLEP has not been widely adopted and represents 4% of procedures, which Dr. Miller attributes to the steep learning curve associated with HoLEP. Lastly, she enumerates the barriers within the US medical system to physicians undertaking the HoLEP learning process and concludes that while Europe has numerous options for physicians to learn the technique, the American focus on robotic surgery means that fewer students learn open orifices surgical procedures.

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Treating BPH: Comparing HoLEP, Rezum, and Urolift

Scott M. Cheney, MD, reviews the background and practical application of minimally-invasive surgical therapies and definitive therapies for benign prostatic hyperplasia (BPH). He then discusses patient selection for these therapy options based on recommendations, level of evidence, and comparative outcomes.

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