The Management of Non-neurogenic Male LUTS (Lower Urinary Tract Symptoms)

A special issue of Uro (ISSN 2673-4397).

Deadline for manuscript submissions: closed (15 April 2022) | Viewed by 22549

Special Issue Editor

Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi University Hospital (AOUC), University of Florence, Florence, Italy
Interests: prostate; benign prostatic hyperplasia; male lower urinary tract symptoms; prostate cancer; kidney cancer; robotic surgery

Special Issue Information

Dear Colleagues,

The latest report on “World Population Ageing 2019” by United Nations reported that population aging is a global phenomenon, with 703 million persons aged 65 years or over around the world in 2019. The number of older persons is projected to double to 1.5 billion in 2050. It is well known that aging is one of the most important risk factors for the development of benign prostatic hyperplasia (BPH) and benign prostatic obstruction (BPO), which can lead to lower urinary tract symptoms (LUTS) and worsen quality of life: about a quarter of middle-aged and elderly men reported clinically relevant LUTS. A number of medical and surgical treatments for LUTS/BPH exist, from phytotherapy to combination therapies, from mini-invasive robot-assisted surgery to open prostatectomy. Recent insights into the pathophysiology and management of male non-neurogenic LUTS have led to the introduction of new concepts such as the patient’s perspective, patient’s quality of life, and focus on treatment-related adverse effects. In this sense, the management of male non-neurogenic LUTS is an intriguing and challenging field in everyday clinical practice that requires continuous updates. In this Special Issue about the management of male non-neurogenic LUTS, we aim to discuss the newest findings concerning the medical and surgical treatment of LUTS, also taking into account the patient’s perspective and quality of life.

Key areas of this Special Issue include but are not limited to prostate, benign prostatic hyperplasia, benign prostatic obstruction, male lower urinary tract symptoms, mini-invasive surgery, phytotherapy, and medical treatment.

We hope to provide readers with an interesting tool for use in everyday clinical practice and invite many colleagues to focus part of their clinical research in the male non-neurogenic LUTS management field.

Prof. Dr. Mauro Gacci
Guest Editor

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Keywords

  • prostate
  • benign prostatic hyperplasia
  • benign prostatic obstruction
  • lower urinary tract symptoms
  • mini-invasive surgery
  • phytotherapy
  • alpha blockers
  • laser surgery
  • 5-alpha-reductase inhibitors
  • quality of life

Published Papers (4 papers)

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Research

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14 pages, 1861 KiB  
Article
Rethinking the Role of Saw Palmetto Extract for Men with Lower Urinary Tract Symptoms in North America
Uro 2022, 2(3), 137-150; https://doi.org/10.3390/uro2030017 - 21 Jun 2022
Cited by 5 | Viewed by 8856
Abstract
Introduction: The effect of the lipidosterolic extract derived from Serenoa repens (commonly known as “saw palmetto extract” or LSESr) berries on benign prostatic hyperplasia (BPH) and male lower urinary tract symptoms (LUTS) has been extensively studied in the global literature. However, a [...] Read more.
Introduction: The effect of the lipidosterolic extract derived from Serenoa repens (commonly known as “saw palmetto extract” or LSESr) berries on benign prostatic hyperplasia (BPH) and male lower urinary tract symptoms (LUTS) has been extensively studied in the global literature. However, a lack of global consensus with regard to its effectiveness remains, resulting in differing recommendations on the role of LSESr in the BPH/LUTS treatment paradigm. Here, we describe the consensus reached by an international panel of urology experts. Methods: In an independent meeting on 24 April 2021, an international panel of urology experts convened with the goal of developing consensus statements to address the following: the differences between the AUA and EAU guidance regarding the use of LSESr for the treatment of BPH/LUTS, the proposed mechanism of action of LSESr, and data examining the efficacy and safety of LSESr. These consensus statements were developed over the course of several months after an extensive review of the global literature and a discussion thereof. Results: A total of seven consensus statements were agreed upon by the panel. These statements addressed the proposed mechanism of action of LSESr, LSESr quality, and the results from clinical trials examining the efficacy and safety of various LSESrs. Conclusion: Based on the reviewed evidence, the panel recommends that LSESr should be considered as a treatment option for men with mild-to-moderate BPH/LUTS as an alternative to watchful waiting. Full article

Review

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25 pages, 2538 KiB  
Review
Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part III
Uro 2021, 1(3), 155-179; https://doi.org/10.3390/uro1030017 - 06 Aug 2021
Cited by 3 | Viewed by 5033
Abstract
Parts I and II of this three-part series indicated how a global review of both English-language and non-English language papers, plus a focus on a lipidosterolic extract of Serenoa repens (LSESr) having a standardized fatty acid profile, have together engendered new insights about [...] Read more.
Parts I and II of this three-part series indicated how a global review of both English-language and non-English language papers, plus a focus on a lipidosterolic extract of Serenoa repens (LSESr) having a standardized fatty acid profile, have together engendered new insights about the biological activity of LSESr vs. LUTS. In this last part, data from the world literature is presented that confirms that LSESr efficacy is the predominant finding in clinical trials. Despite two placebo-controlled clinical trials performed in the U.S. that failed to confirm a benefit of LSESr vs. placebo in LUTS, the global body of the peer-reviewed literature attests not only to efficacy but also to safety. Results will be presented of important trials that compare LSESr to alpha-blockers such as tamsulosin (Flomax®) as well as to 5α-reductase inhibitors such as finasteride (Proscar®) that demonstrate consistent findings of near equivalency between LSESr and these pharmacologic agents. Studies relating data indicative of an additive effect or synergy between LSESr and tamsulosin will also be presented. The heightened effectiveness of LSESr in men with severe LUTS vs. moderate LUTS expands the importance of our scrutiny of the global literature concerning LSESr. Of great consequence are the contributions of non-English language peer-reviewed publications that have consistently provided evidence of LSESr efficacy in treating LUTS/BPH. These peer-reviewed articles have shown that the effect of LSESr is not that of a placebo. Finally, a comparison of the LSESr extraction products used in the treatment of LUTS, and a discussion of the milieu factors that affect the natural history of LUTS and influence the outcome of clinical trials, complete this detailed analysis of LSESr vs. LUTS. Full article
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16 pages, 1814 KiB  
Review
Serenoa Repens (Saw Palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part II
Uro 2021, 1(3), 139-154; https://doi.org/10.3390/uro1030016 - 02 Aug 2021
Cited by 3 | Viewed by 3842
Abstract
Part I of this 3-part series provided the groundwork for understanding the role of a standardized lipidosterolic extract of Serenoa repens (LSESr) in the treatment of LUTS. It documented that a treatment having a high therapeutic index (i.e., a ratio of benefit to [...] Read more.
Part I of this 3-part series provided the groundwork for understanding the role of a standardized lipidosterolic extract of Serenoa repens (LSESr) in the treatment of LUTS. It documented that a treatment having a high therapeutic index (i.e., a ratio of benefit to adverse reactions) is a critical need in the demographic context of a rapidly growing elder population. Part I described the clinical symptomatology of LUTS and how it is quantified. A critique of the reports from four authoritative bodies: the European Scientific Cooperative on Phytotherapy (ESCOP), Cochrane 2012, the European Medicines Agency (EMA), and the AUA (American Urological Association) was presented. The foundation above then fine-tuned our search to require (a) consistent evaluability criteria, (b) the quantification of clinical findings, (c) the need to focus on studies employing a standardized LSESr product meeting the fatty acid profile set forth by the European Medicines Agency (EMA) and the US Pharmacopeia and (d) a global assessment of scientific investigations published in all languages and not limited to only English. With the above four constraints, “new” findings about LSESr vs. LUTS are presented. How did the search strategy and selection criteria lead to new understandings about the role of LSESr vs. LUTS? How safe is LSESr in contrast to its counterpart prescription drugs? Of the proposed major mechanisms of action of LSESr (e.g., 5-alpha reductase inhibition and anti-inflammatory activity), what are the key points? After initiating treatment with LSESr, when is clinical improvement seen? How durable is LSESr in ameliorating LUTS? Can LSESr prevent the progression of BPH? Full article
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21 pages, 1880 KiB  
Review
Serenoa repens (Saw palmetto) for Lower Urinary Tract Symptoms (LUTS): The Evidence for Efficacy and Safety of Lipidosterolic Extracts. Part I
Uro 2021, 1(3), 118-138; https://doi.org/10.3390/uro1030015 - 28 Jul 2021
Cited by 3 | Viewed by 4087
Abstract
Lower urinary tract symptoms (LUTS) are classically characterized as being related to storage (e.g., frequency, urgency, and nocturia) or flow (e.g., weak stream, intermittency, straining, and incomplete emptying). Conventional prescription medications such as α1-blockers and 5α-reductase inhibitors are used to treat progressive LUTS [...] Read more.
Lower urinary tract symptoms (LUTS) are classically characterized as being related to storage (e.g., frequency, urgency, and nocturia) or flow (e.g., weak stream, intermittency, straining, and incomplete emptying). Conventional prescription medications such as α1-blockers and 5α-reductase inhibitors are used to treat progressive LUTS in men. Due to the adverse events associated with these prescription drugs, many patients with mild-to-moderate LUTS may decide to initiate treatment with non-prescription medications and/or dietary supplements. The lipidosterolic extract of Serenoa repens (LSESr), at a recommended daily dose of 320 mg/day, has been the focus of numerous peer-reviewed studies and review articles concerning the treatment of LUTS, from the first publication in 1983 by Boccafoschi to the most recent publication in 2021 by Russo. Although it seems improbable that the beneficial effect of LSESr reflects a placebo effect given the consistent degree of efficacy comparing various studies published in different countries over a span of almost 40 years, this has been the prevailing impression stemming from essentially three publications in the Western medical literature. In addition, despite publications reporting findings of almost identical efficacy using LUTS endpoints such as the International Prostate Symptom Score (IPSS), the quality of life score (QoL), and the peak urinary flow (Qmax) in comparing LSESr with the α-blocker tamsulosin or the 5α-reductase inhibitor finasteride, and despite the recognized acceptance of the hexane lipidosterolic extract product (Permixon®) as an herbal medicine in Europe showing value in the treatment of LUTS, the use of LSESr remains controversial in the US. Contributing to such an opposing view in the US are the wide variability in quality, composition, and dosage of Serenoa products, the commercial prevalence of dried berry powder supplements, and the lack of awareness of a standardized Serenoa phytotherapy lipidosterolic profile. Can the controversy over the efficacy of LSESr in the context of LUTS be resolved? By understanding the main literature that has led to clinical practice guidelines for Serenoa repens for LUTS in Europe and the US, and by an in-depth analysis of the totality of the clinical literature concerning dose, extraction method, and quality of the Serenoa product used, it should be possible to answer this question. Given the extent of this global analysis, this report is presented in three sections. Part I introduces LUTS. What are the demographics of LUTS? What symptoms are assessed by LUTS, and how do we quantify LUTS? Why would a non-prescription item be a valuable consideration in LUTS treatment versus other treatment options? What is basic information about Serenoa repens, and what defines a standardized LSESr product? What are the published trials that have affected the acceptability of Serenoa repens in the treatment of LUTS? Finally, a major portion of Part I discusses the four major reviews of Serenoa repens versus LUTS that have influenced how it is accepted in the USA, in Europe, and in other parts of the world. Part I, therefore, lays the groundwork and is foundational for the important findings relating to LUTS and Serenoa repens that will be presented as Parts II and III in subsequent review articles. Full article
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