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The goal of this revised guideline is to provide a useful reference on the effective evidence-based surgical management of male lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH).
Benign prostatic hyperplasia (BPH) is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and the severity of lower urinary tract symptoms (LUTS) in the aging male can be progressive and is an important diagnosis in the healthcare of patients and the welfare of society. In the management of bothersome LUTS, it is important that healthcare providers recognize the complex dynamics of the bladder, bladder neck, prostate, and urethra. Further, symptoms may result from interactions of these organs as well as with the central nervous system or other systemic diseases (e.g., metabolic syndrome, congestive heart failure). Despite the more prevalent (and generally first line) use of medical therapy for men suffering from LUTS attributed to BPH (LUTS/BPH), there remain clinical scenarios where surgery is indicated as the initial intervention for LUTS/BPH and should be recommended, providing other medical comorbidities do not preclude this approach. It is the hope that this revised Guideline will provide a useful reference on the effective evidence-based management of male LUTS/BPH. Please see the accompanying algorithm for a summary of the procedures detailed in the Guideline.
For the surgical management of BPH, the Minnesota Evidence Review Team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies indexed between January 2007 and September 2017. Following initial publication in 2018, this Guideline underwent an amendment in 2019 that included literature published through January 2019. An additional literature search was conducted through September 2019 and serves as the basis for a 2020 amendment. The Guideline underwent an additional amendment in 2021 to capture eligible literature published between September 2019 and September 2020.
For the medical management of BPH, the Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, the Cochrane Library, and the AHRQ databases to identify eligible studies published and indexed between January 2008 and April 2019. An updated search was completed to capture studies published between April 2019 and December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. Limits were used to restrict the search to English language publications. The review team also reviewed articles for inclusion identified by Guideline Panel Members. The guideline was updated in 2023 to capture eligible literature published between September 2020 and October 2022.
When sufficient evidence existed, the body of evidence was assigned a strength rating of A (high), B (moderate), or C (low) for support of Strong, Moderate, or Conditional Recommendations. In the absence of sufficient evidence, additional information is provided as Clinical Principles and Expert Opinions.
BPH is a histologic diagnosis that refers to the proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and the severity of LUTS in the aging male can be progressive and is an important diagnosis in the healthcare of patients and the welfare of society. In the management of bothersome LUTS, it is important that healthcare providers recognize the complex dynamics of the bladder, bladder neck, prostate, and urethra. Further, symptoms may result from interactions of these organs as well as with the central nervous system or other systemic diseases (e.g., metabolic syndrome, congestive heart failure). Despite the more prevalent (and often first line) use of medical therapy for men suffering from LUTS/BPH, there remain clinical scenarios where surgery is indicated as the initial intervention for LUTS/BPH and should be recommended, providing other medical comorbidities do not preclude this approach.
It is the hope that this revised Guideline will provide a useful reference on the effective evidence-based management of LUTS/BPH. Please see the accompanying algorithm for a summary of the statements detailed in the Guideline.
In preparation for an update of the Guideline, the Panel provided the Minnesota Evidence-based Practice Center with key questions, interventions, comparators, and outcomes to be addressed. The review team worked closely with the Panel to refine the scope, key questions, and inclusion/exclusion criteria.
The key questions were divided into three topics for surgical management of LUTS/BPH: 1. Preoperative parameters that are necessary before surgical intervention is instituted; 2. Surgical management of BOO attributed to BPH; and 3. AUR.
The key questions were divided into two topics for medical management of BPH: 1. Pharmacological management for LUTS/BPH; and 2. Pharmacological management of AUR attributed to BPH. Select newer medications and the long-term side effects of 5-ARIs were the focus of this report.
The Surgical BPH Panel was created in 2016 by the American Urological Association Education and Research, Inc. The Practice Guidelines Committee (PGC) of the AUA selected the Panel Chairs who in turn appointed the additional panel members with specific expertise in this area. In 2019 and 2022, additional panel members were added to help aid in the combination of the Surgical and Medical BPH Guidelines. Funding of the Guideline was provided by the AUA; panel members received no remuneration for their work.
The AUA conducted a thorough peer review process. In 2018, the draft Guideline focusing on surgical management was distributed to 130 peer reviewers of which 58 returned comments. In 2019, the draft Guideline focusing on surgical management was distributed to 74 peer reviewers of which 13 returned comments. In 2020, the draft Guideline focusing on surgical management was distributed to 54 peer reviewers of which nine returned comments. The Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the Guideline was submitted for approval to the PGC and Science and Quality Council (SQC) and, subsequently, to the AUA Board of Directors for final approval.
In 2021, the draft Guideline inclusive of both medical and surgical management options was distributed to 91 peer reviewers of which 43 returned comments. The Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the Guideline was submitted for approval to the PGC and SQC and, subsequently, to the AUA Board of Directors for final approval.
In 2023, as a part of the amendment process, the AUA conducted a thorough peer review process. A call for peer reviewers was posted in April 2023 and the draft guideline document was distributed to 66 peer reviewers, 13 of which submitted comments. The Amendment Panel reviewed and discussed all submitted comments and revised the draft as needed. Once finalized, the guideline was submitted for approval to the original guideline panel, the PGC and SQC. It was then submitted to AUA BODs for final approval. Panel members received no renumeration for their work.
For medical management of BPH, the Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, the Cochrane Library, and the AHRQ databases to identify eligible studies published and indexed between January 2008 and April 2019. An additional search was conducted to obtain studies published from April 2019 to December 2020.
Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. Limits were used to restrict the search to English language publications. The review team also reviewed articles for inclusion identified by the Panel. Limits were used to restrict the search to English language publications.
Abstract review was completed independently by two investigators to determine if citations were eligible for full text review. Two investigators independently reviewed full text articles to identify studies that met inclusion criteria. Conflicts between investigators on inclusion status were resolved through discussion or by a third investigator when necessary. Note, additional studies published outside of search date ranges may have been included to inform background sections or provide historical context.
Overall quality of evidence for the primary outcomes within each comparison was evaluated using GRADEpro4 based on five assessed domains.5, 6 The quality of evidence levels range from high to very low. The five domains include the following: 1. Study limitations (ROB); 2. Directness (single, direct link between intervention and outcome); 3. Consistency (similarity of effect direction and size among studies); 4. Precision (degree of certainty around an estimate assessed in relationship to MDD); and 5. Reporting bias.
The categorization of evidence strength is conceptually distinct from the quality of individual studies. Evidence strength refers to the body of evidence available for a particular question and includes not only individual study quality but consideration of study design, consistency of findings across studies, adequacy of sample sizes, and generalizability of samples, settings, and treatments for the purposes of the Guideline. The AUA categorizes body of evidence strength as Grade A (well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings), Grade B (RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings), or Grade C (RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data). By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty (Table 1).
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