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Purpose: The purpose of this American Urological Association (AUA) Guideline amendment is to provide a useful reference on the effective evidence-based management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH)., Materials and Methods: The Minnesota Evidence Review Team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality (AHRQ) database to identify studies relevant to the management of BPH. 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., Results: The BPH amendment resulted in changes to statements/supporting text on combination therapy, photoselective vaporization of the prostate (PVP), water vapor thermal therapy (WVTT), laser enucleation, and prostate artery embolization (PAE). A new statement on temporary implanted prostatic devices (TIPD) was added. In addition, statements on transurethral needle ablation (TUNA) and transurethral microwave thermotherapy (TUMT) were removed and information regarding these legacy technologies was added to the background section. References and the accompanying treatment algorithms were updated to align with the updated text., Conclusion: This guideline seeks to improve clinicians' ability to evaluate and treat patients with BPH/LUTS based on currently available evidence. Future studies will be essential to further support these statements to improve patient care.

Purpose: Benign prostatic hyperplasia (BPH) is a histologic diagnosis describing proliferation of smooth muscle and epithelial cells within the prostatic transition zone. The prevalence and severity of lower urinary tract symptoms (LUTS) in aging men are progressive and impact the health and welfare of society. This revised Guideline provides a useful reference on effective evidence-based management of male LUTS/BPH. See the accompanying algorithm for a summary of the procedures detailed in the Guideline (figures 1 and 2[Figure: see text][Figure: see text])., Materials and Methods: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible English language studies published between January 2008 and April 2019, then updated through December 2020. Search terms included Medical Subject Headings (MeSH) and keywords for pharmacological therapies, drug classes, and terms related to LUTS or BPH. 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, information is provided as Clinical Principles and Expert Opinions (table 1[Table: see text])., Results: Nineteen guideline statements pertinent to evaluation, work-up, and medical management were developed. Appropriate levels of evidence and supporting text were created to direct both primary care and urologic providers towards streamlined and suitable practices., Conclusions: The work up and medical management of BPH requires attention to individual patient characteristics, while also respecting common principles. Clinicians should adhere to recommendations and familiarize themselves with standards of BPH management.

Purpose: Surgical therapies for symptomatic bladder outlet obstruction (BOO) due to benign prostatic hyperplasia (BPH) are many, and vary from minimally invasive office based to high-cost operative approaches. This Guideline presents effective evidence-based surgical management of male lower urinary tract symptoms secondary/attributed to BPH (LUTS/BPH). See accompanying algorithm for a detailed summary of procedures (figure[Figure: see text])., Materials/methods: The Minnesota Evidence Review Team searched Ovid MEDLINE, Embase, Cochrane Library, and AHRQ databases to identify eligible studies published between January 2007 and September 2020, which includes the initial publication (2018) and amendments (2019, 2020). The Team also reviewed articles identified by Guideline Panel Members. 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, information is provided as Clinical Principles and Expert Opinions (table[Table: see text])., Results: Twenty-four guideline statements pertinent to pre-operative and surgical management were developed. Appropriate levels of evidence and supporting text were created to direct urologic providers towards suitable and safe operative interventions for individual patient characteristics. A re-treatment section was created to direct attention to longevity and outcomes with individual approaches to help guide patient counselling and therapeutic decisions., Conclusion: Pre-operative and surgical management of BPH requires attention to individual patient characteristics and procedural risk. Clinicians should adhere to recommendations and familiarize themselves with criteria that yields the highest likelihood of surgical success when choosing a particular approach for a particular patient.

Purpose: The AUA Guideline panel provides evidence-based recommendations for the surgical management of male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH)., Materials and Methods: The Panel amended the Guideline in 2020 to reflect additional literature published through September 2019. When sufficient evidence existed, the Panel assigned the body of evidence 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, the Panel provided additional information as Clinical Principles and Expert Opinions (See table 1[Table: see text])., Results: Amendments to these Guidelines include: 1) an amended statement (Guideline 1) to include conducting a physical examination; 2) a new statement (Guideline 6) discussing concepts of treatment failure and retreatment; 3) an amended statement (Guideline 15) with updated supporting text for prostatic urethral lift (PUL); 4) an amended statement (Guideline 16) for PUL; 5) an amended statement (Guideline 17) with updated supporting text for transurethral microwave therapy (TUMT); 6) an amended statement (Guideline 18) with updated supporting text for water vapor thermal therapy; 7) updated supporting text for water vapor thermal therapy (Guideline 19); 8) an amended statement (Guideline 21) with updated supporting text for laser enucleation; 9) an amended statement (Guideline 22) with updated supporting text for Aquablation; and 10) an amended statement (Guideline 23) with updated supporting text for Prostate Artery Embolization (PAE)., Conclusions: These evidence-based updates to the AUA Guidelines further inform the surgical management of LUTS/BPH.

Purpose: Male lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) is common in men and can have negative effects on quality of life (QoL). It is the hope that this Guideline becomes a reference for effective evidence-based surgical management of LUTS/BPH., Materials and Methods: The evidence team searched Ovid MEDLINE, the Cochrane Library, and the Agency for Healthcare Research and Quality database to identify studies indexed between January 2007-September 2017. Following initial publication, this guideline was amended in 2019 and reflects relevant literature published through January 2019. 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 (table 1 in supplementary unabridged guideline, https://www.jurology.com)., Results: This Guideline provides evidence-based recommendations regarding management of LUTS/BPH utilizing surgery and minimally invasive surgical therapies (MIST). Additional statements are made regarding diagnostic and pre-operative tests. Clinical statements are made in comparison to what is generally accepted as the gold standard (i.e. transurethral resection of the prostate [TURP] monopolar and/or bipolar). This guideline is designed to be used in conjunction with the associated treatment algorithm (see figure).[Figure: see text]Conclusions:The prevalence and the severity of LUTS increases as men age and is an important diagnosis in the healthcare of patients and the welfare of society. This document will undergo updating as knowledge regarding treatments and future surgical options continues to expand.

Context: Alpha-blockers (ABs) and 5-alpha reductase inhibitors have an established role in treating male lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH). Recently, newer drugs have shown promise for this indication., Objective: To assess the comparative effectiveness and adverse effects (AEs) of newer drugs to treat LUTS attributed to BPH through a systematic review and meta-analysis., Evidence Acquisition: Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases (through June 2016) were hand searches for references of relevant studies. Eligible studies included randomized controlled trials published in English of newer ABs, antimuscarinics, a beta-3 adrenoceptor agonist, phosphodiesterase type-5 inhibitors, or combination therapy with one of these medications as an active comparator. Observational studies of the same agents with a duration ≥1 yr that reported AEs were also included., Evidence Synthesis: We synthesized evidence from 43 randomized controlled trials as well as five observational studies. Based on improvement of mean International Prostate Symptom Score and quality of life scores, the effectiveness of the newer ABs was not different from the older ABs (moderate strength of evidence [SOE]), but had more AEs (low SOE). Antimuscarinics/AB combination therapy had similar outcomes as AB monotherapy (all moderate SOE), but often had more AEs. Phosphodiesterase type-5 inhibitors alone or in combination with ABs had similar or inferior outcomes than ABs alone. Evidence was insufficient for the beta-3 adrenoceptor agonist. For all newer agents, the evidence was generally insufficient to assess long-term efficacy, prevention of symptom progression, or AEs., Conclusions: None of the drugs or drug combinations newly used to treat LUTS attributed to BPH showed outcomes superior to traditional AB treatment. Given the lack of superior outcomes, the studies' short time-horizon, and less assurance of their safety, their current value in treating LUTS attributable to BPH appears low., Patient Summary: In this paper, we reviewed the evidence of newer drugs to treat men with urinary problems attributable to an enlarged prostate. We found none of the new drugs to be better but there was more concern about side effects., (Copyright © 2016 European Association of Urology. All rights reserved.)

Benign prostatic hyperplasia (BPH) is a highly prevalent and costly condition that affects older men worldwide. Many affected men develop lower urinary tract symptoms, which can have a negative impact on their quality of life. In the past, transurethral resection of the prostate (TURP) was the mainstay of treatment. However, several efficacious drug treatments have been developed, which have transformed BPH from an acute surgical entity to a chronic medical condition. Specifically, multiple clinical trials have shown that α adrenoceptor antagonists can significantly ameliorate lower urinary tract symptoms. Moreover, 5α reductase inhibitors, alone or combined with an α adrenoceptor antagonist, can reverse the natural course of BPH, reducing the risk of urinary retention and the need for surgical intervention. Newer medical regimens including the use of antimuscarinic agents or phosphodiesterase type 5 inhibitors, have shown promise in men with predominantly storage symptoms and concomitant erectile dysfunction, respectively. For men who do not adequately respond to conservative measures or pharmacotherapy, minimally invasive surgical techniques (such as transurethral needle ablation, microwave thermotherapy, and prostatic urethral lift) may be of benefit, although they lack the durability of TURP. A variety of laser procedures have also been introduced, whose improved hemostatic properties abrogate many of the complications associated with traditional surgery., (© BMJ Publishing Group Ltd 2014.)

Background: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate, which can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (SR), which is also known by its botanical name of Sabal serrulatum, is one of several phytotherapeutic agents available for the treatment of BPH., Objectives: This systematic review aimed to assess the effects and harms of Serenoa repens in the treatment of men with LUTS consistent with BPH., Search Methods: We searched for trials in general and in specialized databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE®, EMBASE, CINAHL®, Web of Science, SCOPUS, BIOSIS Previews®, LILACS, ClinicalTrials.gov, Controlled-Trials.com, World Health Organization (WHO), and Google Scholar. We also handsearched systematic reviews, references, and clinical practice guidelines. There were no language restrictions., Selection Criteria: Trials were eligible if they randomized men with symptomatic BPH to receive preparations of SR (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and included clinical outcomes, such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers (JT, RM)., Data Collection and Analysis: One review author (JT) extracted Information on patients, interventions, and outcomes which was then checked by another review author (RM). The main outcome measure for comparing the effectiveness of SR with active or inert controls was change in urologic symptom-scale scores, with validated scores taking precedence over non validated ones. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for harms was the number of men reporting side effects., Main Results: In a meta-analysis of two high quality long-term trials (n = 582), Serenoa repens therapy was not superior to placebo in reducing LUTS based on the AUA (mean difference (MD) 0.25 points, 95% confidence interval (CI) -0.58 to 1.07). A 72 week trial with high quality evidence, using the American Urological Association Symptom Score Index, reported that SR was not superior to placebo at double and triple doses. In the same trial the proportions of clinical responders (≥ three-point improvement) were nearly identical (42.6% and 44.2% for SR and placebo, respectively), and not significant (RR 0.96, 95% CI 0.76 to 1.22).This update, which did not change our previous conclusions, included two new trials with 444 additional men, an 8.5% (5666/5222) increase from our 2009 updated review, and a 28.8% (1988/1544) increase for our main comparison, SR monotherapy versus placebo control (17 trials). Overall, 5666 men were assessed from 32 randomized, controlled trials, with trial lengths from four to 72 weeks. Twenty-seven trials were double blinded and treatment allocation concealment was adequate in 14.In a trial of high quality evidence (N = 369), versus placebo, SR did not significantly decrease nightly urination on the AUA Nocturia scale (range zero to five) at 72 weeks follow-up (one-sided P = 0.19).The three high quality, moderate-to-long term trials found peak urine flow was not improved with Serenoa repens compared with placebo (MD 0.40 mL/s, 95% CI -0.30 to 1.09).Comparing prostate size (mean change from baseline), one high quality 12-month trial (N = 225) reported no significant difference between SR and placebo (MD -1.22 cc, 95% CI -3.91 to 1.47)., Authors' Conclusions: Serenoa repens, at double and triple doses, did not improve urinary flow measures or prostate size in men with lower urinary tract symptoms consistent with BPH.

Background: Transurethral resection of the prostate (TURP) has been the gold-standard treatment for alleviating urinary symptoms and improving urinary flow in men with symptomatic benign prostatic hyperplasia (BPH). However, the morbidity of TURP approaches 20%, and less invasive techniques have been developed for treating BPH. Preliminary data suggest that microwave thermotherapy, which delivers microwave energy to produce coagulation necrosis in prostatic tissue, is a safe, effective treatment for BPH., Objectives: To assess the therapeutic efficacy and safety of microwave thermotherapy techniques for treating men with symptomatic benign prostatic obstruction., Search Methods: Randomized controlled trials were identified from The Cochrane Library, MEDLINE, EMBASE, bibliographies of retrieved articles, reviews, technical reports, and by contacting relevant expert trialists and microwave manufacturers., Selection Criteria: All randomized controlled trials evaluating transurethral microwave thermotherapy (TUMT) for men with symptomatic BPH were eligible for this review. Comparison groups could include transurethral resection of the prostate, minimally invasive prostatectomy techniques, sham thermotherapy procedures, and medications. Outcome measures included urinary symptoms, urinary function, prostate volume, mortality, morbidity, and retreatment. Two review authors independently identified potentially relevant abstracts and then assessed the full papers for inclusion., Data Collection and Analysis: Two review authors independently abstracted study design, baseline characteristics, and outcomes data and assessed methodological quality using a standard form. We attempted to obtain missing data from authors or sponsors, or both., Main Results: In this update, we identified no new randomized comparisons of TUMT that provided evaluable effectiveness data. Fifteen studies involving 1585 patients met the inclusion criteria, including six comparisons of microwave thermotherapy with TURP, eight comparisons with sham thermotherapy procedures, and one comparison with an alpha-blocker. Study durations ranged from 3 to 60 months. The mean age of participants was 66.8 years and the baseline symptom scores and urinary flow rates, which did not differ across treatment groups, demonstrated moderately severe lower urinary tract symptoms. The pooled mean urinary symptom scores decreased by 65% with TUMT and by 77% with TURP. The weighted mean difference (WMD) with 95% confidence interval (CI) for the International Prostate Symptom Score (IPSS) was -1.00 (95% CI -2.03 to -0.03), favoring TURP. The pooled mean peak urinary flow increased by 70% with TUMT and by 119% with TURP. The WMD for peak urinary flow was 5.08 mL/s (95% CI 3.88 to 6.28 mL/s), favoring TURP. Compared to TURP, TUMT was associated with decreased risks for retrograde ejaculation, treatment for strictures, hematuria, blood transfusions, and the transurethral resection syndrome, but increased risks for dysuria, urinary retention, and retreatment for BPH symptoms. Microwave thermotherapy improved IPSS symptom scores (WMD -5.15, 95% CI -4.26 to -6.04) and peak urinary flow (WMD 2.01 mL/s, 95% CI 0.85 to 3.16) compared with sham procedures. Microwave thermotherapy also improved IPSS symptom scores (WMD -4.20, 95% CI -3.15 to -5.25) and peak urinary flow (WMD 2.30 mL/s, 95% CI 1.47 to 3.13) in the one comparison with alpha-blockers. No studies evaluated the effects of symptom duration, patient characteristics, prostate-specific antigen levels, or prostate volume on treatment response., Authors' Conclusions: Microwave thermotherapy techniques are effective alternatives to TURP and alpha-blockers for treating symptomatic BPH in men with no history of urinary retention or previous prostate procedures and prostate volumes between 30 to 100 mL. However, TURP provided greater symptom score and urinary flow improvements and reduced the need for subsequent BPH treatments compared to TUMT. Small sample sizes and differences in study design limit comparisons between devices with different designs and energy levels. The effects of symptom duration, patient characteristics, or prostate volume on treatment response are unknown.

Objective: To determine the impact of evaluative care guideline compliance on surgical intervention for benign prostatic hyperplasia (BPH)., Methods: From Medicare claims data, we developed a cohort of men new to a urologist with a diagnosis of BPH. We determined urologists' compliance with guideline recommended care (3 months) and their time- and geography-standardized average monthly Medicare expenditures (1 year). At the level of the urologist, we assessed the impact of these measures on the use of surgical therapy within 1 year of the new patient visit., Results: Of 10 248 patients in the cohort, 675 received surgical intervention (6.7%). Guideline compliance (2% received surgery in highest quintile; 11% lowest quintile) was associated with surgical intervention. The results were robust to adjustment for patient and surgeon factors (Guideline Compliance, odds ratio = 0.09; 95% confidence interval = 0.06-0.15, highest to lowest adherence)., Conclusion: Urologists who tend to follow the AUA best practice guidelines for BPH evaluation perform surgical interventions on their BPH patients less frequently than urologists who do not follow these guidelines., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Unlabelled: What's known on the subject? and What does the study add? For the past 30 years Serenoa repens has become a widely used phytotherapy in the USA and in Europe, mostly because of positive comparisons to α-blockers and 5α-reductase inhibitors. During the last 4 years we have seen two very high quality trials comparing Serenoa repens to placebo and up to 72 weeks' duration. These trials found Serenoa repens no better than placebo, even (in one trial) at escalating doses., Objective: • To estimate the effectiveness and harms of Serenoa repens monotherapy in the treatment of lower urinary tract symptoms (LUTS) consistent with benign prostatic hyperplasia (BPH)., Materials and Methods: • We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and other sources through to January 2012 to identify randomised trials. • Trials were eligible if they randomised men with symptomatic BPH to receive Serenoa repens extract monotherapy for at least 4 weeks in comparison with placebo, and assessed clinical outcomes and urodynamic measurements. • Our primary outcome was improvement in LUTS, based on change in urological symptom-scale scores., Results: • In all, 17 randomised controlled trials (N= 2008) assessing Serenoa repens monotherapy (typically 320 mg/day) vs placebo met inclusion criteria, although only five reported American Urological Association Symptom Index (AUASI) or International Prostate Symptom Scores (IPSS). Trial lengths ranged from 4 to 72 weeks. The mean age of all enrolees was 64.3 years and most participants were of White race. The mean baseline total score was 14 points, indicating moderately severe symptoms. In all, 16 trials were double blinded and adequate treatment allocation concealment was reported in six trials. • In a meta-analysis of three high quality long-to-moderate term trials (n= 661), Serenoa repens therapy was no better than placebo in reducing LUTS based on the AUASI/IPSS (weighted mean difference [WMD]-0.16 points, 95% confidence interval [CI]-1.45 to 1.14) or maximum urinary flow rate (Q(max) ; WMD 0.40 mL/s, 95% CI -0.30 to 1.09). Based on mostly short-term studies, Q(max) measured at study endpoint were also not significantly different between treatment groups (WMD 1.15 mL/s, 95% CI -0.23 to 2.53) with evidence of substantial heterogeneity (I(2) 58%). • One long-term dose escalation trial (72 weeks) found double and triple doses of Serenoa repens extract did not improve AUASI compared with placebo and the proportions of clinical responders (≥ 3 point decrease in the AUASI) were nearly identical (43% vs 44% for Serenoa repens and placebo, respectively) with a corresponding risk ratio of 0.96 (95% CI 0.76-1.22). • Long-term, Serenoa repens therapy was no better than placebo in improving nocturia in one high-quality study (P= 0.19). Pooled analysis of nine short-term Permixon® trials showed a reduction in the frequency of nocturia (WMD -0.79 times/night, 95% CI-1.28 to -0.29), although there was evidence of heterogeneity (I(2) 76%) • Adverse events of Serenoa repens extracts were few and mild, and incidences were not statistically significantly different vs placebo. Study withdrawals occurred in ≈ 10% and did not differ between Serenoa repens and placebo., Conclusions: • Serenoa repens therapy does not improve LUTS or Q(max ) compared with placebo in men with BPH, even at double and triple the usual dose. • Adverse events were generally mild and comparable to placebo., (© 2012 BJU INTERNATIONAL. NO CLAIM TO ORIGINAL US GOVERNMENT WORKS.)

Purpose: Benign prostatic hyperplasia creates significant expenses for the Medicare program. We determined expenditure trends for benign prostatic hyperplasia evaluative testing after urologist consultation and placed these trends in the context of overall Medicare expenditures., Materials and Methods: Using a 5% national sample of Medicare beneficiaries from 2000 to 2007 we developed a cohort of 40,253 with claims for new visits to urologists for diagnoses consistent with symptomatic benign prostatic hyperplasia. We assessed trends in initial inflation and geography adjusted expenditures within 12 months of diagnosis by evaluative test categories derived from the 2003 American Urological Association guideline on the management of benign prostatic hyperplasia. Using governmental reports on Medicare expenditure trends for benign prostatic hyperplasia we compared expenditures to overall and imaging specific Medicare expenditures. Comparisons were assessed by the Z-test and regression analysis for linear trends, as appropriate., Results: Between 2000 and 2007 inflation adjusted total Medicare expenditures per patient for the initial evaluation of patients with benign prostatic hyperplasia seen by urologists increased from $255.44 to $343.98 (p <0.0001). Benign prostatic hyperplasia related imaging increases were significantly less than overall Medicare imaging expenditure increases (55% vs 104%, p <0.001). The increase in per patient expenditures for benign prostatic hyperplasia was significantly lower than the increase in overall Medicare expenditures per enrollee (35% vs 45%, p = 0.0015)., Conclusions: From 2000 to 2007 inflation adjusted expenditures increased for benign prostatic hyperplasia related evaluations. This growth was slower than the overall growth in Medicare expenditures. The increase in BPH related imaging expenditures was restrained compared to that of the Medicare program as a whole., (Copyright © 2012 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Lower urinary tract symptoms associated with benign prostatic obstruction (BPO) occur in up to 70% of men over the age of 60 years. To relieve these bothersome symptoms, treatment options include alpha-antagonists, also know as alpha-blockers., Objectives: We conducted a systematic review to evaluate the effectiveness and adverse effects of the alpha-blocker, terazosin, for treatment of urinary symptoms associated with BPO., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers., Selection Criteria: Studies were included if they (1) were randomized trials of at least 1 month duration, and (2) included men with symptomatic BPO and compared terazosin with placebo or active controls., Data Collection and Analysis: Study, patient characteristics and outcomes data were extracted in duplicate onto standardized forms utilizing a prospectively developed protocol. The main outcome measure for comparing the effectiveness of terazosin with placebo or other BPO medications was change in urological symptoms as measured by validated symptom scores. Secondary outcomes included urodynamic measures. The main outcome measure for adverse effects was the number of men reporting side effects. We also evaluated the number of men withdrawing from treatment and the number withdrawing due to adverse effects., Main Results: Seventeen studies involving 5151 subjects met inclusion criteria (placebo-controlled (n = 10); alpha-blockers (n = 7); finasteride alone or in combination with terazosin as well as placebo (1); microwave therapy (TUMT) (1). Study duration ranged from 4 to 52 weeks. Mean age was 65 years and 82% of men were white. Baseline urologic symptom scale scores and flow rates demonstrated that men had moderate BPO. Efficacy outcomes were rarely reported in a fashion that allowed for data pooling but indicated that terazosin improved symptom scores and flow rates more than placebo or finasteride and similarly to other alpha antagonists. The pooled mean percentage improvements for the Boyarsky symptom score was 37% for terazosin versus 15% for placebo (n = 4 studies). The mean percentage improvement for the American Urological Association symptom score (AUA) was 38% compared to 17% and 20% for placebo and finasteride, respectively (n = 2 studies). The pooled mean improvement in the International Prostate Symptom Score (IPSS) (40%) was similar to tamsulosin (43%). Peak urine flow rates improved greater with terazosin (22%), than placebo (11%) and finasteride (15%) but did not differ significantly from the other alpha-blockers. The percentage of men discontinuing terazosin was comparable to men receiving placebo and finasteride but was greater then with other alpha-antagonists. Adverse effects were greater than placebo and included dizziness, asthenia, headache, and postural hypotension., Authors' Conclusions: The available evidence suggests that terazosin improves urinary symptoms and flow measures associated with BPO. Effectiveness is superior to placebo or finasteride, similar to other alpha-blockers but less than TUMT. Adverse effects were generally mild but more frequent than other alpha-blockers and associated with between a two-to-four fold increase in treatment discontinuation.

Background: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate which can result in bothersome lower urinary tract symptoms. The treatment goal for men with BPH is to relieve these bothersome symptoms., Objectives: This systematic review assessed the effects of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) compatible with BPH., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers., Selection Criteria: Trials were eligible if they (1) randomized men with BPH to receive tamsulosin in comparison with placebo, other BPH medications or surgical interventions and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements, and (3) had a treatment duration of 30 days or longer. Eligibility was assessed by at least two independent observers., Data Collection and Analysis: Information on patients, interventions, and outcomes were extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of tamsulosin with placebo, medical or surgical interventions was the change in urologic symptom scale scores. Secondary outcomes included changes in urinary flow measures (peak urine flow rate). The main outcome measure for adverse effects was the number of men reporting adverse effects., Main Results: Fourteen studies involving 4122 subjects met inclusion criteria. Study duration ranged from 4 to 26 weeks, and no placebo-controlled study lasted longer than 13 weeks. The mean age of subjects was 64 years. Baseline symptom scores and urine flow rates demonstrated that men had moderate LUTS. Tamsulosin improved symptoms and peak urine flow relative to placebo. The weighted mean differences (WMD) for mean change from baseline for the Boyarsky symptom score for 0.4 mg and 0.8 mg doses of tamsulosin relative to placebo were -1.1 points (95% CI = -1.49 to -0.72; 12% improvement) and -1.6 points (95% CI = -2.3 to -1.0; 16% improvement), respectively. The WMD for mean change from baseline in peak urine flow were 1.1 mL/sec (95% CI = 0.59 to 1.51) and 1.1 mL/sec (95% CI= 0.65 to 1.48) for 0.4 mg and 0.8 mg, respectively. Tamsulosin (0.2 mg to 0.4 mg) was as effective as other alpha antagonists and the phytotherapeutic agent Permixon® in improving symptoms and flow rates though the doses of all alpha-antagonists studied may not have been optimal. Discontinuations from treatment for any reason and discontinuations "due to adverse events" were similar in the low dose tamsulosin (0.2 mg) and placebo groups but increased to 16% in trials utilizing a 0.8 mg dose of tamsulosin. Low dose tamsulosin was generally well tolerated although not all the trials reported specific adverse events. The most frequently reported adverse events that were significantly greater than placebo included dizziness, rhinitis and abnormal ejaculation. Adverse effects increased markedly as tamsulosin dosing increased, and were reported in 75% of men receiving the 0.8 mg dose. Men receiving a 0.2 mg dose tamsulosin were less likely to discontinue treatment compared to men receiving terazosin., Authors' Conclusions: Tamsulosin provided a small to moderate improvement in urinary symptoms and flow compared to men receiving placebo in men with BPH. Effectiveness was similar to other alpha antagonists and increased only slightly with higher doses. Long term effectiveness and ability to reduce complications due to BPH progression could not be determined. Adverse effects were generally mild but their frequency, including withdrawals, increased substantially with the higher doses that are generally available for treatment.

Objectives: To improve benign prostatic hyperplasia (BPH) care, the American Urological Association created the best practice guidelines for BPH management. We evaluated the trends in use of BPH-related evaluative tests and the extent to which urologists comply with the guidelines for these evaluative tests., Methods: From a 5% random sample of Medicare claims from 1999 to 2007, we created a cohort of 10,248 patients with new visits for BPH to 748 urologists. The trends in use of BPH-related testing were determined. After classifying urologists by compliance with the best practice guidelines, the models were fit to determine the differences in the use of BPH-related testing among urologists. Additional models were used to define the extent to which individual BPH-related tests influenced guideline compliance., Results: The use of most BPH testing increased with time (P<.001) except for prostate-specific antigen (declined; P<.001) and ultrasonography (P=.416). Northeastern and Midwestern urologists were more likely to be in the lowest compliance group compared with Southern and Western urologists (29%, 27%, 13%, and 19%, respectively; P=.01). The testing associated with high guideline compliance included urinalysis and prostate-specific antigen measurement (P<.01 for both). Prostate ultrasonography (P=.03), cystoscopy (P<.01), uroflow (P<.01), and postvoid residual urine volume determination (P=.02) were associated with low guideline compliance. Urodynamics, postvoid residual urine volume, cytology, serum creatinine, and upper tract imaging were not strongly associated with guideline compliance., Conclusions: Despite the American Urological Association guidelines for BPH care, wide variations in the evaluation and treatment were seen. Improving guideline adherence and reducing variation could improve BPH care quality., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Benign prostatic hyperplasia (BPH), nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH has been growing steadily. Cernilton, prepared from the rye-grass pollen Secale cereale, is one of the several phytotherapeutic agents available for the treatment of BPH., Objectives: This systematic review aims to assess the effects of Cernilton on urinary symptoms and flow measures in men with benign prostatic hyperplasia (BPH)., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library, Phytodok), by checking bibliographies, and by contacting manufacturers and researchers., Selection Criteria: Trials were eligible if they were: (1) randomized controlled trials or controlled clinical trials comparing Cernilton with placebo or other BPH medications in men with BPH; and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements., Data Collection and Analysis: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. Main outcome measure for comparing the effects of Cernilton with placebo and standard BPH medications were the change in urologic symptoms scales. Secondary outcomes included changes in nocturia as well as urodynamic measures (peak and mean urine flow, residual volume, prostate size). Main outcome measure for side effects was the number of men reporting side effects., Main Results: Four hundred forty-four men were enrolled in two placebo-controlled and two comparative trials lasting from 12 to 24 weeks. Three studies used a double-blind method although treatment allocation concealment was unclear in all. Cernilton improved "self rated urinary symptoms" (percent reporting satisfactory or improving symptoms) versus placebo and Tadenan. The weighted risk ratio (RR) for self-rated improvement versus placebo was 2.40 (95% CI = 1.21 to 4.75), and the weighted RR versus Tadenan was 1.42 (95% CI = 1.21 to 4.75). Cernilton reduced nocturia compared with placebo and Paraprost. Versus placebo, the weighted RR was 2.05 (95% CI = 1.41 to 3.00), and versus Paraprost, the WMD was -0.40 times per evening (95% CI = -0.73 to -0.07). Cernilton was not more effective than placebo or the comparative study agents in improving urinary flow rates, residual volume or prostate size. Adverse events were rare and mild. The withdrawal rate for Cernilton was 4.8% compared to 2.7% for placebo and 5.2% for Paraprost., Authors' Conclusions: The Cernilton trials analyzed were limited by short duration, limited number of enrollees, gaps in reported outcomes, and unknown quality of the preparations utilized. The comparative trials lacked a proven active control. The available evidence suggests Cernilton is well tolerated and modestly improves overall urologic symptoms including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.

Objectives: To investigate the degree to which expenditures on symptom evaluations vary among urologists and the factors associated with such variation. As the medical and surgical specialists for men with lower urinary tract symptoms (LUTS), urologists provide testing to evaluate symptoms and determine therapy., Methods: We developed a cohort of men with an initial urologist visit for benign prostatic hyperplasia (BPH) from a 5% sample of Medicare patients (1999-2007) and established a physician level factor, practice style, as a function of average per patient expenditures. We then determined which AUA BPH guideline elements explained variation in quantity and expenditures for BPH testing, and also examined the impact of patient and physician factors on practice style., Results: A nearly 15-fold variation in urologists' average per-patient expenditures existed ($35 to $527 per month; Median $92). Practice styles were associated with physician (P < .01 all examined variables) and patient (P < .01 for comorbidity, race/ethnicity, and socioeconomic status) factors. Guideline recommended care was provided at lower rates by the lowest expenditure urologists compared with middle- to highest-intensity urologists (P < .01). Practice style variations were attributable mainly to differences in tests characterized by the guidelines as optional and not-recommended (P < .01)., Conclusions: Expenditures for BPH evaluations vary substantially by geography, practice setting, and experience and are accounted for largely by differences in the use of optional and not-routinely recommended tests. Greater standardization could enhance patient care and reduce health care costs., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Benign prostatic hyperplasia (BPH), a non-malignant enlargement of the prostate in aging men, can cause bothersome urinary symptoms (intermittency, weak stream, straining, urgency, frequency, incomplete emptying). Finasteride, a five-alpha reductase inhibitor (5ARI), blocks the conversion of testosterone to dihydrotestosterone, reduces prostate size, and is commonly used to treat symptoms associated with BPH., Objectives: To compare the clinical effectiveness and harms of finasteride versus placebo and active controls in the treatment of lower urinary tract symptoms (LUTS)., Search Strategy: We searched The Cochrane Library (which includes CDSR (Cochrane Database of Systematic Reviews), DARE (Database of Abstracts of Reviews of Effects), HTA (Heath Technology Assessments), and CENTRAL (Cochrane Central Register of Controlled Trials, and which includes EMBASE and MEDLINE), LILACS (Latin American and Caribbean Center on Health Sciences Information) and Google Scholar for randomized, controlled trials (RCTs). We also handsearched systematic reviews, references, and clinical-practice guidelines., Selection Criteria: Randomized trials in the English language with placebo and/or active arms with a duration of at least 6 months., Data Collection and Analysis: JT extracted the data, which included patient characteristics, outcomes, and harms. Our primary outcome was change in a validated, urinary symptom-scale score, such as the AUA/IPSS. A clinically meaningful change was defined as 4 points. We also categorized outcomes by trial lengths of ≤ 1 year (short term) and > 1 year (long term)., Main Results: Finasteride consistently improved urinary symptom scores more than placebo in trials of > 1 year duration, and significantly lowered the risk of BPH progression (acute urinary retention, risk of surgical intervention, ≥ 4 point increase in the AUASI/IPSS). In comparison to alpha-blocker monotherapy, finasteride was less effective than either doxazosin or terazosin, but equally effective compared to tamsulosin. Both doxazosin and terazosin were significantly more likely than finasteride to improve peak urine flow and nocturia, versus finasteride. Versus tamsulosin, peak urine flow and QoL improved equally well versus finasteride. However, finasteride was associated with a lower risk of surgical intervention compared to doxazosin, but not to terazosin, while finasteride and doxazosin were no different for risk of acute urinary retention. Two small trials reported no difference in urinary symptom scores between finasteride and tamsulosin. Finasteride + doxazosin and doxazosin monotherapy improved urinary symptoms equally well (≥ 4 point improvement).For finasteride, there was an increased risk of ejaculation disorder, impotence, and lowered libido, versus placebo. Versus doxazosin, finasteride had a lower risk of asthenia, dizziness, and postural hypotension, and versus terazosin, finasteride had a significant, lower risk of asthenia, dizziness, and postural hypotension., Authors' Conclusions: Finasteride improves long-term urinary symptoms versus placebo, but is less effective than doxazosin. Long-term combination therapy with alpha blockers (doxazosin, terazosin) improves symptoms significantly better than finasteride monotherapy. Finasteride + doxazosin improves symptoms equally - and clinically - to doxazosin alone. In comparison to doxazosin, finasteride + doxazosin appears to improve urinary symptoms only in men with medium (25 to < 40 mL) or large prostates (≥ 40 mL), but not in men with small prostates (25 mL).Comparing short to long-term therapy, finasteride does not improve symptoms significantly better than placebo at the short term, but in the long term it does, although the magnitude of differences was very small (from < 1.0 point to 2.2 points). Doxazosin improves symptoms better than finasteride both short and long term, with the magnitude of differences ∼2.0 points and 1.0 point, respectively. Finasteride + doxazosin improves scores versus finasteride alone at both short and long term, with mean differences ∼2.0 points for both time points. Finasteride + doxazosin versus doxazosin improves scores equally for short and long term.Drug-related adverse effects for finasteride are rare; nevertheless, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder, versus placebo. Versus doxazosin, which has higher rates of dizziness, postural hypotension, and asthenia, men taking finasteride are at increased risk for impotence, erectile dysfunction, decreased libido, and ejaculation disorder. Finasteride significantly reduces asthenia, postural hypotension, and dizziness versus terazosin. Finasteride significantly lowers the risk of asthenia, dizziness, ejaculation disorder, and postural hypotension, versus finasteride + terazosin.

Background: Benign prostatic hyperplasia (BPH) is a common condition in aging men causing lower urinary tract symptoms (LUTS). Treatment aims are to relieve symptoms and prevent disease progression. Of the different alpha-1 adrenergic receptors (ARs) in the prostate, alpha-1a receptors are known to be central to prostatic smooth-muscle contraction. Recent studies have shown that patients with BPH may also have a predominance of alpha-1d receptors., Objectives: To evaluate the efficacy and adverse effects of naftopidil, a selective alpha-1d oral alpha-blocking agent for the treatment of LUTS associated with BPH., Search Strategy: Systematic review of trials published January 1950 to January 2009. Sources included MEDLINE and bibliographies of retrieved articles and review articles., Selection Criteria: Eligible trials included: men diagnosed with symptomatic BPH; compared Naftopidil to placebo, control, or combination therapy; evaluated clinically relevant outcomes between randomized groups; had at least 4-weeks follow up; and were published in English language., Data Collection and Analysis: Participant demographics and comorbidities, enrollment criteria, outcomes, adverse events, numbers and reasons for dropouts were extracted onto standardized extraction forms by one reviewer. The mean change and per cent improvement from baseline in AUA (American Urological Association Symptom Score) and IPSS (International Prostate Symptom Score) scores and other efficacy outcomes for treatment and control groups were calculated. If feasible, the efficacy outcomes and adverse events data were pooled., Main Results: Eight trials were eligible (N = 744 participants). All trials were conducted in Japan. Study duration ranged from 4 to 17 weeks. The mean age of participants was 68 years; pretreatment mean IPSS = 17.8 and mean peak urine flow (Qmax) = 9.5 mL/s (milliliters/second). No trials compared naftopidil to placebo. In 5 trials (N = 419), naftopidil in doses of 25 to 75 mg/d (milligrams/day) showed a mean IPSS improvement similar to low-dose tamsulosin (0.2 mg/d) (8.4 versus 8.9 points). Compared to a phytotherapy preparation (eviprostat), naftopidil significantly improved total IPSS (-5.9 versus 0.4; P < 0.0002). In one trial, the addition of anticholinergic drugs (oxybutynin or propiverine hydrochloride) to naftopidil did not offer any significant improvement for IPSS or Qmax in comparison to treatment with naftopidil alone. Although IPSS did not significantly differ between high- (75 mg/d) and low-dose (25mg/d) naftopidil, high dose significantly improved Qmax compared to low dose (1.2 mL/s versus 0.2 mL/s). Adverse events reported were few, mild and similar to those seen with 0.2 mg/d tamsulosin., Authors' Conclusions: There are no data from placebo controlled trials regarding the efficacy of naftopidil in men with symptomatic BPH. Limited information suggests that treatment with naftopidil provides short-term improvement in urinary symptom-scale scores (total IPSS/AUA), QoL (quality of life) score, and urinary symptoms from baseline comparable to low-dose tamsulosin. Adverse effects due to naftopidil were few and usually mild.

Background: Benign prostatic hyperplasia (BPH), a nonmalignant enlargement of the prostate, can lead to obstructive and irritative lower urinary tract symptoms (LUTS). The pharmacologic use of plants and herbs (phytotherapy) for the treatment of LUTS associated with BPH is common. The extract of the berry of the American saw palmetto, or dwarf palm plant, Serenoa repens (also known by its botanical name of Sabal serrulatum), is one of several phytotherapeutic agents available for the treatment of BPH., Objectives: This systematic review aimed to assess the effects of Serenoa repens in the treatment of LUTS consistent with BPH., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, and The Cochrane Library), by checking bibliographies, and by handsearching the relevant literature., Selection Criteria: Trials were eligible if they (1) randomized men with symptomatic BPH to receive preparations of Serenoa repens (alone or in combination) for at least four weeks in comparison with placebo or other interventions, and (2) included clinical outcomes such as urologic symptom scales, symptoms, and urodynamic measurements. Eligibility was assessed by at least two independent observers., Data Collection and Analysis: Information on patients, interventions, and outcomes was extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of Serenoa repens with placebo or other interventions was the change in urologic symptom-scale scores. Secondary outcomes included changes in nocturia and urodynamic measures. The main outcome measure for side effects or adverse events was the number of men reporting side effects., Main Results: In this update 9 new trials involving 2053 additional men (a 64.8% increase) have been included. For the main comparison - Serenoa repens versus placebo - 3 trials were added with 419 subjects and 3 endpoints (IPSS, peak urine flow, prostate size). Overall, 5222 subjects from 30 randomized trials lasting from 4 to 60 weeks were assessed. Twenty-six trials were double blinded and treatment allocation concealment was adequate in eighteen studies.Serenoa repens was not superior to placebo in improving IPSS urinary symptom scores, (WMD (weighted mean difference) -0.77 points, 95% CI -2.88 to 1.34, P > 0.05; 2 trials), finasteride (MD (mean difference) 0.40 points, 95% CI -0.57 to 1.37, P > 0.05; 1 trial), or tamsulosin (WMD -0.52 points, 95% CI -1.91 to 0.88, P > 0.05; 2 trials).For nocturia, Serenoa repens was significantly better than placebo (WMD -0.78 nocturnal visits, 95% CI -1.34 to -0.22, P < 0.05; 9 trials), but with the caveat of significant heterogeneity (I(2) = 66%). A sensitivity analysis, utilizing higher quality, larger trials (>/= 40 subjects), demonstrated no significant difference (WMD -0.31 nocturnal visits, 95% CI -0.70 to 0.08, P > 0.05; 5 trials) (I(2) = 11%). Serenoa repens was not superior to finasteride (MD -0.05 nocturnal visits, 95% CI -0.49 to 0.39, P > 0.05; 1 trial), or to tamsulosin (per cent improvement) (RR) (risk ratio) 0.91, 95% CI 0.66 to 1.27, P > 0.05; 1 trial).Comparing peak urine flow, Serenoa repens was not superior to placebo at trial endpoint (WMD 1.02 mL/s, 95% CI -0.14 to 2.19, P > 0.05; 10 trials), or by comparing mean change (WMD 0.31 mL/s, 95% CI -0.56 to 1.17, P > 0.05; 2 trials).Comparing prostate size at endpoint, there was no significant difference between Serenoa repens and placebo (MD -1.05 cc, 95% CI -8.84 to 6.75, P > 0.05; 2 trials), or by comparing mean change (MD -1.22 cc, 95% CI -3.91 to 1.47, P > 0.05; 1 trial)., Authors' Conclusions: Serenoa repens was not more effective than placebo for treatment of urinary symptoms consistent with BPH.

Purpose: We describe the trends in transurethral prostatectomy and minimally invasive surgical treatments for benign prostate hyperplasia from 1999 through 2005 among elderly male Medicare beneficiaries., Materials and Methods: Benign prostatic hyperplasia surgeries were identified using the annual 100% Medicare carrier files which contain physician claims for services reimbursed under Medicare Part B. The annual age group specific procedure rates as well as the age adjusted rates by race and percent of each procedure performed in different clinical settings were calculated., Results: The total number of benign prostatic hyperplasia procedures increased 44% from 88,868 in 1999 to 127,786 in 2005. The minimally invasive surgical treatment procedure counts increased 529% from 11,582 to 72,887 and the rates increased 439% from 136 to 678 per 100,000 males during that period. The transurethral prostate resection rate decreased approximately 5% per year. By 2005 minimally invasive surgical treatment procedures accounted for 57% of total benign prostatic hyperplasia surgeries, while transurethral prostate resection accounted for only 39%. Almost all transurethral microwave thermotherapy, 86% of transurethral needle ablation and 54% of laser coagulation procedures were performed in office clinics, and 78% of laser vaporization procedures were performed in hospital outpatient clinics. Black beneficiaries were 17% less likely to receive minimally invasive surgical treatment than whites in 2005., Conclusions: The increase of total benign prostatic hyperplasia procedure rate was driven by a marked increase in minimally invasive surgical treatment and a continuing decrease of transurethral prostate resection. Differences in the use of minimally invasive surgical treatment across age and racial groups persisted. This dramatic change in the pattern of benign prostatic hyperplasia surgical treatment may have a profound impact on health care expenditures and outcomes, and requires further investigation.

Background: Transurethral resection of the prostate (TURP) has been the gold-standard treatment for alleviating urinary symptoms and improving urinary flow in men with symptomatic benign prostatic hyperplasia (BPH). However, the morbidity of TURP approaches 20%, and less invasive techniques have been developed for treating BPH. Preliminary data suggest that microwave thermotherapy, which delivers microwave energy to produce coagulation necrosis in prostatic tissue, is a safe, effective treatment for BPH., Objectives: To assess the therapeutic efficacy and safety of microwave thermotherapy techniques for treating men with symptomatic benign prostatic obstruction., Search Strategy: Randomized controlled trials were identified from the Cochrane Collaboration Library, MEDLINE, EMBASE, bibliographies of retrieved articles and reviews, and by contacting expert relevant trialists and microwave manufacturers., Selection Criteria: All randomized controlled trials evaluating transurethral microwave thermotherapy (TUMT) for men with symptomatic BPH were eligible for this review. Comparison groups could include transurethral resection of the prostate, minimally invasive prostatectomy techniques, sham thermotherapy procedures, and medications. Outcome measures included urinary symptoms, urinary function, prostate volume, mortality, morbidity, and retreatment. Two reviewers independently identified potentially relevant abstracts and then assessed the full papers for inclusion., Data Collection and Analysis: Two reviewers independently abstracted study design, baseline characteristics and outcomes data and assessed methodological quality using a standard form. We attempted to obtain missing data from authors and/or sponsors., Main Results: Fourteen studies involving 1493 patients met inclusion criteria, including six comparisons of microwave thermotherapy with TURP, seven comparisons with sham thermotherapy procedures, and one comparison with an alpha blocker. Study durations ranged from 3 to 60 months. The mean age of subjects was 66.8 years, and the baseline symptom scores and urinary flow rates, which did not differ across treatment groups, demonstrated moderately severe lower urinary tract symptoms. The pooled mean urinary symptom scores decreased by 65% with TUMT and by 77% with TURP. The weighted mean difference (WMD) (95% confidence interval) for the symptom score was -1.36 (-2.25 to -0.46), favoring TURP. The pooled mean peak urinary flow increased by 70% with TUMT and by 119% with TURP. The WMD for peak urinary flow was 5.08 (3.88 to 6.28) mL/s, favoring TURP. Compared to TURP, TUMT was associated with decreased risks for retrograde ejaculation, treatment for strictures, hematuria, blood transfusions, and the transurethral resection syndrome, but increased risks for dysuria, urinary retention, and retreatment for BPH symptoms. Microwave thermotherapy improved symptom scores (IPSS WMD -4.75, 95% CI -3.89 to -5.60) and peak urinary flow (WMD 1.67 mL/s, 95% CI 0.99 to 2.34) compared with sham procedures. Microwave thermotherapy also improved symptom scores (IPSS WMD -4.20, 95% CI -3.15 to -5.25) and peak urinary flow (WMD 2.30 mL/s, 95% CI 1.47 to 3.13) in the one comparison with alpha blockers. No studies evaluated the effects of symptom duration, patient characteristics, prostate-specific antigen levels, or prostate volume on treatment response., Authors' Conclusions: Microwave thermotherapy techniques are effective alternatives to TURP and alpha-blockers for treating symptomatic BPH for men with no history of urinary retention or previous prostate procedures and prostate volumes between 30 to 100 mL. However, TURP provided greater symptom score and urinary flow improvements and reduced the need for subsequent BPH treatments compared to TUMT. Small sample sizes and differences in study design limit comparison between devices with different designs and energy levels. The effects of symptom duration, patient characteristics, or prostate volume on treatment response are unknown.

We evaluated the efficacy and safety of alpha 1--blocker doxazosin for treatment of lower urinary tract symptoms (LUTS) compatible with benign prostatic hypertrophy (BPH). Fourteen randomized controlled trials enrolled 6261 men, average age 64 years, who had moderately severe LUTS and flow impairment. Compared with baseline measures and placebo effect, doxazosin resulted in a statistically significant improvement in both LUTS and flow. However, when compared with placebo, the average magnitude of symptom improvement (International Prostate Symptom Score [IPSS] improvement < 3 points) typically did not achieve a level detectable by patients. Combined doxazosin and finasteride therapy improved LUTS and reduced the risk of overall clinical progression of BPH compared to each drug separately in men followed over 4 years. Reported mean changes from baseline in the IPSS were -7.4, -6.6, -5.6, and -4.9 points for combination therapy, doxazosin, finasteride, and placebo, respectively. Combination therapy reduced the need for invasive treatment for BPH and the risk of long-term urinary retention. The absolute reductions compared with placebo were less than 4% and primarily seen in men with prostate gland volume > 40 mL or PSA levels > 4 ng/mL. Efficacy was comparable with other alpha 1--blockers. Withdrawals from treatment for any cause were comparable to placebo. Dizziness and fatigue occurred more frequently with doxazosin compared to placebo.

Objectives: To evaluate the efficacy and adverse effects of alfuzosin for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)., Methods: The included studies were randomized controlled trials involving men with symptomatic BPH treated with alfuzosin versus placebo or active control for at least 4 weeks., Results: The search strategy identified 11 trials involving 3901 men with a mean age of 64 years. Eight trials were placebo-controlled studies, two were alfuzosin versus alternative alpha-blockers, and one was alfuzosin versus finasteride and combination alfuzosin/finasteride therapy. The study durations were short term, 4 to 26 weeks. The mean baseline symptom scores and peak urinary flow rates were indicative of moderate BPH. Alfuzosin (7.5 or 10 mg) improved lower urinary tract symptoms assessed by the International Prostate Symptom Score compared with placebo. The mean absolute change from baseline was -5.4 points for alfuzosin compared with -3.6 points for placebo, a weighted mean difference of 1.8 points (three studies). Alfuzosin increased the peak urinary flow more than did placebo, although the improvement varied across the eight studies. Symptom and flow improvements were generally comparable to that with combination therapy and with other alpha1-blockers. Alfuzosin had good short-term tolerability, and the numbers of study withdrawals were comparable to those with placebo and controls. Efficacy and short-term safety were similar across the various (immediate-release, sustained, and once-daily) formulations., Conclusions: The results from short-term studies have indicated that alfuzosin improves lower urinary tract symptoms and urinary flow more than does placebo and is generally well tolerated in men with symptomatic BPH. Long-term efficacy and safety studies in combination with a 5-alpha-reductase inhibitor should be initiated.

Objective: To evaluate the efficacy and adverse effects of doxazosin for treating lower urinary tract symptoms (LUTS) compatible with benign prostatic obstruction (BPO)., Methods: Randomized controlled trials were included in the meta-analysis if: the study duration was > or = 1 month; the study involved men with symptomatic BPO; and doxazosin was compared with placebo or active controls. Study and patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol., Results: Thirteen studies involving 6033 men with (mean age 64 years) met the inclusion criteria; 10 were placebo-controlled, including two with combined doxazosin/finasteride therapy and finasteride monotherapy arms. Three trials were a comparison with other alpha-blockers. The study duration was 1-54 months. The mean baseline symptom scores and peak urinary flow (PUF) rates were indicative of moderate BPO. Doxazosin gave significant improvements in LUTS, assessed by symptom scores, vs placebo and finasteride in the short- to long-term. Two long-term studies (1 and 4 years) reported mean changes from baseline for the International Prostate Symptom Score of - 8.3 and - 6.6 points (-49% and - 39%) for doxazosin and - 5.7 and - 4.9 points (-33% and - 29%) for placebo, respectively. Doxazosin significantly increased PUF rates vs placebo. In pooled results from three studies, the weighted mean difference in the mean change from baseline vs placebo was 1.6 mL/s (95% confidence interval 1.2-2.1). Efficacy was comparable with other alpha1-blockers. In the long-term (>4 years) doxazosin was no better then finasteride in improving PUF. Combined doxazosin and finasteride significantly reduced the risk of overall clinical progression of BPO vs each drug separately in men followed for >4 years. Absolute risk reductions vs placebo were 11.3%, 6.9% and 6.4% for combined therapy, doxazosin and finasteride, respectively (P < 0.001). Improvements in symptom scores and PUF were also significantly greater with combined than monotherapy, and the former reduced the need for invasive treatment for BPO and the risk of long-term urinary retention, although the absolute reductions in risk vs placebo were small (<4%). Dizziness and fatigue were significantly more common with doxazosin than placebo (11% vs 7%, and 6% vs 3%, respectively). Adverse events reported for combined therapy were similar to those with each monotherapy., Conclusion: The evidence indicates that doxazosin is effective and generally well tolerated for improving LUTS and PUF in men with symptomatic BPO. Combined therapy was better than doxazosin alone in reducing the risk of clinical progression of BPO and other long-term complications related to BPO.

Objective: To conduct a systematic review of randomized controlled trials evaluating the efficacy and safety of transurethral microwave thermotherapy (TUMT) compared with transurethral resection of the prostate (TURP) in treating men with symptomatic benign prostatic hyperplasia (BPH)., Methods: We searched Medline, the Cochrane Library and reference lists of retrieved studies to identify randomized trials of >/= 6 months duration with >/= 10 patients in each treatment arm. Data were extracted on study design, patient and treatment characteristics, urinary symptoms, urinary flow, adverse events and repeat treatment for BPH., Results: Six studies were evaluated, involving 540 patients. The mean age (67.8 years), baseline symptom score (19.5), and peak urinary flow (PUF, 8.6 mL/s) did not differ by treatment group. The pooled mean urinary symptom score decreased by 65% with TUMT and 77% with TURP. The weighted mean (95% confidence interval) difference for the symptom score at the follow-up was -1.83 (-3.09 to -0.58) points, favouring TURP. The pooled mean PUF increased by 70% with TUMT and 119% with TURP. The weighted mean difference for the PUF at the follow-up was 5.37 (4.22-6.51) mL/s, favouring TURP. Retrograde ejaculation (57.6% vs 22.2%), transfusions (5.7% vs 0%) and re-treatment for strictures (relative hazard 9.76) were all significantly more common after TURP, but re-treatment for BPH was significantly more common after TUMT (relative hazard 10.0)., Conclusions: TUMT techniques are effective and safe short-term alternatives to TURP for treating BPH. However, TURP provided greater symptom and urinary flow improvements and fewer subsequent BPH treatments than TUMT.

Background: Symptomatic benign prostatic obstruction is a common problem for older men. The gold standard treatment, transurethral resection of the prostate (TURP), significantly improves urinary symptoms and urinary flow. However, TURP has up to a 20% morbidity. Currently, there are a number of minimally invasive procedures that may be safe, effective alternatives to TURP. One promising surgical technique is laser prostatectomy., Objectives: To assess the therapeutic efficacy and safety of laser prostatectomy techniques for treating men with symptomatic benign prostatic obstruction., Search Strategy: Randomized controlled trials were identified from the Cochrane Collaboration Library, MEDLINE, EMBASE, bibliographies of retrieved articles and reviews, and contacting expert relevant trialists and laser manufacturers., Selection Criteria: All randomized controlled trials evaluating laser prostatectomy treatment for men with symptomatic BPH. Trials were eligible if they (1) were randomized comparisons of a laser technique with TURP, (2) included at least 10 men with BPO in each treatment arm, (3) provided at least 6-months follow-up, and (4) included clinical outcomes such as urologic symptom scales or urodynamic measurements., Data Collection and Analysis: Data extraction and assessment of methodologic quality was performed independently by two reviewers. Information on study design, subject and treatment characteristics, adverse events, urinary symptoms, and urinary flow were extracted using a standard form., Main Results: 20 studies involving 1898 subjects were evaluated, including studies 4 with multiple comparisons. We found 8 comparisons of TURP with contact lasers, 8 with non-contact lasers, 4 with hybrid techniques, and one with interstitial laser coagulation (ILC). Two studies compared transurethral electrovaporization (TUVP) with contact lasers, one study compared interstitial laser coagulation with transurethral microwave thermotherapy (TUMT), and one study compared holmium contact lasers (HoLRP) with open prostatectomy. Among the studies comparing laser prostatectomy with TURP, follow-up duration ranged from 6 to 36 months. Mean age (67.2 yrs), mean baseline symptom score (20.2), and mean baseline peak urinary flow (9.2 ml/s) did not differ by treatment group. The pooled percentage improvements for mean urinary symptoms ranged from 59% to 68% with lasers and 63% to 77% with TURP. The improvements for mean peak urinary flow ranged from 56% to 119% with lasers and 96% to 127% with TURP. Overall, laser subjects were less likely to receive transfusions or develop strictures and their hospitalizations were shorter. Non-contact laser subjects were more likely to have dysuria, urinary tract infection, and retention. Re-operation occurred more often following laser procedures., Reviewer's Conclusions: Laser techniques are a useful alternative to TURP for treating BPO. Small sample sizes and differences in study design limit any definitive conclusions regarding the preferred type of laser technique. Data were insufficient to compare laser techniques with other minimally invasive procedures.

Background: Benign prostatic hyperplasia (BPH) is a nonmalignant enlargement of the prostate which can result in bothersome lower urinary tract symptoms. The treatment goal for men with BPH is to relieve these bothersome symptoms., Objectives: This systematic review assessed the effects of tamsulosin in the treatment of lower urinary tract symptoms (LUTS) compatible with BPH., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, EMBASE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers., Selection Criteria: Trials were eligible if they (1) randomized men with BPH to receive tamsulosin in comparison with placebo, other BPH medications or surgical interventions and (2) included clinical outcomes such as urologic symptom scales, symptoms, or urodynamic measurements, and (3) had a treatment duration of 30 days or longer. Eligibility was assessed by at least two independent observers., Data Collection and Analysis: Information on patients, interventions, and outcomes were extracted by at least two independent reviewers using a standard form. The main outcome measure for comparing the effectiveness of tamsulosin with placebo, medical or surgical interventions was the change in urologic symptom scale scores. Secondary outcomes included changes in urinary flow measures (peak urine flow rate). The main outcome measure for adverse effects was the number of men reporting adverse effects., Main Results: Fourteen studies involving 4,122 subjects met inclusion criteria. Study duration ranged from 4-26 weeks, and no placebo-controlled study lasted longer than 13 weeks. The mean age of subjects was 64 years. Baseline symptom scores and urine flow rates demonstrated that men had moderate LUTS. Tamsulosin improved symptoms and peak urine flow relative to placebo. The weighted mean differences (WMD) for mean change from baseline for the Boyarsky symptom score for 0.4 mg and 0.8 mg doses of tamsulosin relative to placebo were -1.1 points (95% CI = -1.49, -0.72; 12% improvement) and -1.6 points (95% CI = -2.3, -1.0; 16% improvement), respectively. The WMD for mean change from baseline in peak urine flow were 1.1 mL/sec (95% CI = 0.59, 1.51) and 1.1 mL/sec (95% CI= 0.65, 1.48) for 0.4 mg and 0.8 mg, respectively. Tamsulosin (0.2 mg-0.4 mg) was as effective as other alpha antagonists and the phytotherapeutic agent Permixon in improving symptoms and flow rates though the doses of all alpha-antagonists studied may not have been optimal. Discontinuations from treatment for any reason and discontinuations "due to adverse events" were similar in the low dose tamsulosin (0.2 mg) and placebo groups but increased to 16% in trials utilizing a 0.8 mg dose of tamsulosin. Low dose tamsulosin was generally well tolerated although not all the trials reported specific adverse events. The most frequently reported adverse events that were significantly greater than placebo included dizziness, rhinitis and abnormal ejaculation. Adverse effects increased markedly as tamsulosin dosing increased, and were reported in 75% of men receiving the 0.8 mg dose. Men receiving a 0.2 mg dose tamsulosin were less likely to discontinue treatment compared to men receiving terazosin., Reviewer's Conclusions: Tamsulosin provided a small to moderate improvement in urinary symptoms and flow compared to men receiving placebo in men with BPH. Effectiveness was similar to other alpha antagonists and increased only slightly with higher doses. Long term effectiveness and ability to reduce complications due to BPH progression could not be determined. Adverse effects were generally mild but their frequency, including withdrawals, increased substantially with the higher doses that are generally available for treatment.

Purpose: We conducted a systematic review of randomized controlled trials evaluating the efficacy and safety of laser prostatectomy techniques compared to transurethral resection of the prostate for symptomatic benign prostatic obstruction., Materials and Methods: We searched MEDLINE, the Cochrane library and reference lists of retrieved studies to identify randomized trials of 6 months or greater in duration with at least 10 subjects in each treatment arm. We extracted data on study design, subject and treatment characteristics, adverse events, urinary symptoms and urinary flow., Results: A total of 16 studies involving 1,488 subjects were evaluated, including 8 comparisons of transurethral resection with contact lasers, 7 with noncontact lasers and 4 with hybrid techniques. Study duration ranged from 6 to 36 months. Mean patient age (67.4 years), baseline symptom score (20.2) and peak urinary flow (9.5 ml. per second) did not differ by treatment group. Transurethral resection of the prostate provided slightly greater improvement in urinary symptoms and flow. The pooled mean percentage improvement for urinary symptoms ranged from 59% to 68% with lasers and 63% to 77% with transurethral resection. Improvement for peak urinary flow ranged from 56% to 119% with lasers and 96% to 127% with transurethral resection of the prostate. Laser procedures resulted in fewer transfusions (less than 1% versus 7%) and strictures (0% to 7% versus 8%), and required shorter hospitalizations. Reoperation occurred more often (RR = 5.7) following laser procedures., Conclusions: Laser techniques are a useful alternative to transurethral resection of the prostate for treating benign prostatic obstruction. Small sample sizes and differences in study design limit any definitive conclusions regarding the preferred type of laser technique.

Objective: To systematically review and evaluate the effectiveness and adverse effects of the alpha-antagonist, terazosin, for treating urinary symptoms associated with benign prostatic obstruction (BPO)., Methods: Studies were sought and included in the review if they were randomized trials of at least 1 month duration, involved men with symptomatic BPO and compared terazosin with placebo or active controls. The study, patient characteristics and outcome data were extracted in duplicate onto standardized forms using a prospectively developed protocol., Results: Seventeen studies involving 5151 men met the inclusion criteria, i.e. placebo-controlled (10), alpha-blockers (seven), finasteride alone or combined with terazosin and placebo (one), and microwave therapy (one). The study duration was 4-52 weeks; the mean age of the men was 65 years and 82% were white. Baseline urological symptom scale scores and flow rates showed that men had moderate BPO. Efficacy outcomes were rarely reported in a way that allowed for data pooling, but indicated that terazosin improved symptom scores and flow rates more than did placebo or finasteride, and similarly to other alpha-antagonists. The pooled mean percentage improvement for the Boyarsky symptom score was 37% for terazosin and 15% for placebo (four studies). The mean percentage improvement for the American Urological Association symptom score was 38%, compared with 17% and 20% for placebo and finasteride, respectively (two studies). The pooled mean improvement in the International Prostate Symptom Score of 40% was similar to that with tamsulosin (43%). Peak urinary flow rates improved more with terazosin (22%) than with placebo (11%) and finasteride (15%), but did not differ significantly from the other alpha-antagonists. The percentage of men discontinuing terazosin was comparable with those receiving placebo and finasteride, but greater than with other alpha-antagonists. Adverse effects were greater than with placebo and included dizziness, asthenia, headache and postural hypotension., Conclusions: The available evidence indicates that terazosin improves the symptoms and flow rates associated with BPO; it was more effective than placebo or finasteride and similar to other alpha-antagonists. Adverse effects were generally mild but more frequent than with other alpha-antagonists and associated with a two- to four-fold increase in treatment discontinuation.

Purpose: We systematically reviewed the effectiveness and adverse effects of tamsulosin for lower urinary tract symptoms compatible with benign prostatic obstruction., Materials and Methods: Studies were included in analysis when they involved a randomized trial of at least 1 month in duration, men with lower urinary tract symptoms and a comparison of tamsulosin with placebo or an active control. Study, patient and outcome data were extracted onto standard forms using a prospective protocol., Results: Of the series 13 involving 3,418 men with a mean age of 64 years met our inclusion criteria. Study duration was 4 to 26 weeks. Baseline symptom scores and flow rates showed moderate lower urinary tract symptoms. Tamsulosin improved symptoms and peak urine flow compared with placebo. The weighted mean difference in the mean change from baseline for the Boyarsky symptom score for 0.4 and 0.8 mg. tamsulosin versus placebo was -1.1 (95% confidence interval [CI] -1.49 to -0.72 or 12% improvement) and -1.6 points (95% CI -2.3 to -1.0 or 16% improvement), respectively. The weighted mean difference in the mean change from baseline in peak urine flow was 1.1 (95% CI 0.59 to 1.51) and 1.1 ml. per second (95% CI 0.65 to 1.48) for 0.4 and 0.8 mg., respectively. The 0.2 to 0.4 mg. tamsulosin dose was as effective as other alpha-antagonists for improving symptoms and the flow rate, although the doses of all alpha-antagonists evaluated may not have been optimal. Treatment withdrawals and adverse effects increased markedly as the tamsulosin dose increased., Conclusions: Tamsulosin improves lower urinary tract symptoms and flow. Its effectiveness was similar to that of other alpha-antagonists, increasing slightly at higher doses. Adverse effects were generally mild but the incidence, including treatment withdrawals, increased substantially at higher doses.

Background: Lower urinary tract symptoms associated with benign prostatic obstruction (BPO) occur in up to 70% of men over the age of 60 years. To relieve these bothersome symptoms, treatment options include alpha-antagonists, also know as alpha-blockers., Objectives: We conducted a systematic review to evaluate the effectiveness and adverse effects of the alpha-blocker, terazosin, for treatment of urinary symptoms associated with BPO., Search Strategy: Trials were searched in computerized general and specialized databases (MEDLINE, Cochrane Library), by checking bibliographies, and by contacting manufacturers and researchers., Selection Criteria: Studies were included if they (1) were randomized trials of at least 1 month duration, and (2) included men with symptomatic BPO and compared terazosin with placebo or active controls., Data Collection and Analysis: Study, patient characteristics and outcomes data were extracted in duplicate onto standardized forms utilizing a prospectively developed protocol. The main outcome measure for comparing the effectiveness of terazosin with placebo or other BPO medications was change in urological symptoms as measured by validated symptom scores. Secondary outcomes included urodynamic measures. The main outcome measure for adverse effects was the number of men reporting side effects. We also evaluated the number of men withdrawing from treatment and the number withdrawing due to adverse effects., Main Results: 17 studies involving 5,151 subjects met inclusion criteria (placebo-controlled (10); alpha-blockers (7); finasteride alone or in combination with terazosin as well as placebo (1); microwave therapy (TUMT) (1). Study duration ranged from 4-52 weeks. Mean age was 65 years and 82% of men were white. Baseline urologic symptom scale scores and flow rates demonstrated that men had moderate BPO. Efficacy outcomes were rarely reported in a fashion that allowed for data pooling but indicated that terazosin improved symptom scores and flow rates more than placebo or finasteride and similarly to other alpha antagonists. The pooled mean percentage improvements for the Boyarsky symptom score was 37% for terazosin versus 15% for placebo (n=4 studies). The mean percentage improvement for the American Urological Association symptom score (AUA) was 38% compared to 17% and 20% for placebo and finasteride, respectively (n = 2 studies). The pooled mean improvement in the International Prostate Symptom Score (IPSS) (40%) was similar to tamsulosin (43%). Peak urine flow rates improved greater with terazosin (22%), than placebo (11%) and finasteride (15%) but did not differ significantly from the other alpha-blockers. The percentage of men discontinuing terazosin was comparable to men receiving placebo and finasteride but was greater then with other alpha-antagonists. Adverse effects were greater than placebo and included dizziness, asthenia, headache and postural hypotension., Reviewer's Conclusions: The available evidence suggests that terazosin improves urinary symptoms and flow measures associated with BPO. Effectiveness is superior to placebo or finasteride, similar to other alpha-blockers but less than TUMT. Adverse effects were generally mild but more frequent than other alpha-blockers and associated with between a two-four fold increase in treatment discontinuation.

Objective: To systematically review the existing evidence regarding the efficacy and safety of phytotherapeutic compounds used to treat men with symptomatic benign prostatic hyperplasia (BPH)., Design: Randomized trials were identified searching MEDLINE (1966--1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. The studies were included if men had symptomatic benign prostatic hyperplasia, the intervention was a phytotherapeutic preparation alone or combined, a control group received placebo or other pharmacologic therapies for BPH, and the treatment duration was at least 30 days. Key data were extracted independently by two investigators., Results: A total of 44 studies of six phytotherapeutic agents (Serenoa repens, Hypoxis rooperi, Secale cereale, Pygeum africanum, Urtica dioica, Curcubita pepo) met inclusion criteria and were reviewed. Many studies did not report results in a method allowing meta-analysis. Serenoa repens, extracted from the saw palmetto, is the most widely used phytotherapeutic agent for BPH. A total of 18 trials involving 2939 men were reviewed. Compared with men receiving placebo, men taking Serenoa repens reported greater improvement of urinary tract symptoms and flow measures. Serenoa repens decreased nocturia (weighted mean difference (WMD) = -0.76 times per evening; 95% CI = -1.22 to -0.32; n = 10 studies) and improved peak urine flow (WMD = 1.93 ml s(-1); 95% CI = 0.72 to 3.14, n = 8 studies). Men treated with Serenoa repens rated greater improvement of their urinary tract symptoms versus men taking placebo (risk ratio of improvement = 1.72; 95% CI = 1.21 to 2.44, n = 8 studies). Improvement in symptoms of BPH was comparable to men receiving the finasteride. Hypoxis rooperi (n = 4 studies, 519 men) was also demonstrated to be effective in improving symptom scores and flow measures compared with placebo. For the two studies reporting the International Prostate Symptom Score, the WMD was -4.9 IPSS points (95% CI = -6.3 to -3.5, n = 2 studies) and the WMD for peak urine flow was 3.91 ml s(-1) (95% CI = 0.91 to 6.90, n = 4 studies). Secale cereale (n = 4 studies, 444 men) was found to modestly improve overall urological symptoms. Pygeum africanum (n = 17 studies, 900 men) may be a useful treatment option for BPH. However, review of the literature has found inadequate reporting of outcomes which currently limit the ability to estimate its safety and efficacy. The studies involving Urtica dioica and Curcubita pepo are limited although these agents may be effective combined with other plant extracts such as Serenoa and Pygeum. Adverse events due to phytotherapies were reported to be generally mild and infrequent., Conclusions: Randomized studies of Serenoa repens, alone or in combination with other plant extracts, have provided the strongest evidence for efficacy and tolerability in treatment of BPH in comparison with other phytotherapies. Serenoa repens appears to be a useful option for improving lower urinary tract symptoms and flow measures. Hypoxis rooperi and Secale cereale also appear to improve BPH symptoms although the evidence is less strong for these products. Pygeum africanum has been studied extensively but inadequate reporting of outcomes limits the ability to conclusively recommend it. There is no convincing evidence supporting the use of Urtica dioica or Curcubita pepo alone for treatment of BPH. Overall, phytotherapies are less costly, well tolerated and adverse events are generally mild and infrequent. Future randomized controlled trials using standardized preparations of phytotherapeutic agents with longer study durations are needed to determine their long-term effectiveness in the treatment of BPH.

Purpose: To conduct a systematic review and quantitative meta-analysis of the therapeutic efficacy and tolerability of Pygeum africanum in men with symptomatic benign prostatic hyperplasia., Methods: Studies were identified through the search of Medline (1966 to 2000), Embase, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies. Randomized trials were included if participants had symptomatic benign prostatic hyperplasia, the intervention was a preparation of P. africanum alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacologic therapies for benign prostatic hyperplasia, and treatment duration was at least 30 days. Two investigators independently extracted key data on design features, subject characteristics, and therapy allocation., Results: A total of 18 randomized controlled trials involving 1,562 men met the inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Only 1 of the studies reported a method of treatment allocation concealment, although 17 were double-blinded. The mean study duration was 64 days (range 30 to 122). Compared with placebo in 6 studies, P. africanum provided a moderately large improvement in the combined outcome of urologic symptoms and flow measures as assessed by an effect size defined by the difference of the mean change for each outcome divided by the pooled standard deviation for each outcome (-0.8 SD [95% confidence interval (CI): -1.4 to -0.3]). Summary estimates of individual outcomes were also improved by P. africanum. Men were more than twice as likely to report an improvement in overall symptoms (risk ratio = 2.1, 95% CI: 1.40 to 3.1). Nocturia was reduced by 19% and residual urine volume by 24%; peak urine flow was increased by 23%. Adverse effects due to P. africanum were mild and similar to placebo. The overall dropout rate was 12% and was similar for P. africanum (13%), placebo (11%), and other controls (8%; P = 0.4 versus placebo and P = 0.5 versus other controls)., Conclusions: The literature on P. africanum for the treatment of benign prostatic hyperplasia is limited by the short duration of studies and the variability in study design, the use of phytotherapeutic preparations, and the types of reported outcomes. However, the evidence suggests that P. africanum modestly, but significantly, improves urologic symptoms and flow measures. Further research is needed using standardized preparations of P. africanum to determine its long-term effectiveness and ability to prevent complications associated with benign prostatic hyperplasia.

Objective: To systematically review the evidence for the clinical effects and safety of the rye-grass pollen extract (Cernilton) in men with symptomatic benign prostatic hyperplasia (BPH)., Methods: Trials were identified by searching Medline, specialized databases (EMBASE, Cochrane Library, Phytodok), bibliographies, and contacting relevant trialists and manufacturers. Randomized or controlled clinical trials were included if: men with symptomatic BPH were treated with Cernilton; a control group received either placebo or pharmacological therapy; the treatment duration was >/= 30 days; and clinical outcomes were reported., Results: In all, 444 men were enrolled in two placebo-controlled and two comparative trials lasting 12-24 weeks. Three studies used a double-blind method although the concealment of treatment allocation was unclear in all. Cernilton improved 'self-rated urinary symptoms' (the proportion reporting satisfactory or improving symptoms) vs placebo and another plant product, Tadenan. The weighted mean (95% confidence interval) risk ratio (RR) for self-rated improvement vs placebo was 2.40 (1. 21-4.75) and the weighted RR vs Tadenan was 1.42 (1.21-4.75). Cernilton reduced nocturia compared with placebo or Paraprost (a mixture of amino acids); against placebo, the weighted RR was 2.05 (1.41-3.00), and against Paraprost the weighted mean difference for nocturia was - 0.40 times per evening (- 0.73 to 0.07). Cernilton did not improve urinary flow rates, residual volume or prostate size compared with placebo or the comparative study agents. Adverse events were rare and mild; the withdrawal rate for Cernilton was 4. 8%, compared with 2.7% for placebo and 5.2% for Paraprost., Conclusions: The Cernilton trials analysed were limited by their short duration, limited number of enrolees, omissions in reported outcomes, and the unknown quality of the preparations used. The comparative trials had no confirmed active control. The available evidence suggests that Cernilton is well tolerated and modestly improves overall urological symptoms, including nocturia. Additional randomized placebo and active-controlled trials are needed to evaluate the long-term clinical effectiveness and safety of Cernilton.

Objectives: To conduct a systematic review of the evidence for the efficacy of beta-sitosterol in men with symptomatic benign prostatic hyperplasia (BPH)., Methods: Studies were identified through Medlinetrade mark (1966-98), EMBASEtrade mark, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with study authors and pharmaceutical companies. Randomized trials were included if: men had symptomatic BPH; plant extract preparations contained beta-sitosterols; a control group received placebo or a pharmacological therapy; and treatment duration was >/=30 days. Study characteristics, demographic information, enrolment criteria and outcomes were extracted., Results: Four trials comprising a total of 519 men met the inclusion criteria. All were double-blind and lasted 4-26 weeks. Three studies used nonglucosidic beta-sitosterols and one used a preparation that contained only beta-sitosterol-beta-d-glucoside. Compared with placebo, beta-sitosterol improved urinary symptom scores and flow measures. For the two studies reporting the International Prostate Symptom Score (IPSS), the weighted mean difference (WMD) against placebo was -4.9 IPSS points (95% confidence interval, CI,-6.3 to-3.5). The WMD for peak urinary flow rate was 3.91 mL/s (95% CI 0.91 to 6.90, four studies) and for residual volume the WMD was -28.62 mL (95% CI-41.42 to-15.83, four studies). beta-sitosterol did not reduce prostate size. The trial using pure beta-sitosterol-beta-d-glucoside (WA184) showed no improvement in urinary flow measures. Withdrawal rates for men assigned to beta-sitosterol and placebo were 7.8% and 8.0% (not significant), respectively., Conclusion: beta-sitosterol improves urological symptoms and flow measures. However, the existing studies are limited by short treatment duration and lack of standardized beta-sitosterol preparations. Their long-term effectiveness, safety and ability to prevent the complications of BPH are unknown.

Objective: To conduct a systematic review and, where possible, quantitative meta-analysis of the existing evidence regarding the therapeutic efficacy and safety of the saw palmetto plant extract, Serenoa repens, in men with symptomatic benign prostatic hyperplasia (BPH)., Data Sources: Studies were identified through the search of MEDLINE (1966-1997), EMBASE, Phytodok, the Cochrane Library, bibliographies of identified trials and review articles, and contact with relevant authors and drug companies., Study Selection: Randomized trials were included if participants had symptomatic BPH, the intervention was a preparation of S repens alone or in combination with other phytotherapeutic agents, a control group received placebo or other pharmacological therapies for BPH, and the treatment duration was at least 30 days., Data Extraction: Two investigators for each article (T.J.W., A.I., G.S., and R.M.) independently extracted key data on design features, subject characteristics, therapy allocation, and outcomes of the studies., Data Synthesis: A total of 18 randomized controlled trials involving 2939 men met inclusion criteria and were analyzed. Many studies did not report results in a method that permitted meta-analysis. Treatment allocation concealment was adequate in 9 studies; 16 were double-blinded. The mean study duration was 9 weeks (range, 4-48 weeks). As compared with men receiving placebo, men treated with S repens had decreased urinary tract symptom scores (weighted mean difference [WMD], -1.41 points [scale range, 0-19] [95% confidence interval (CI), -2.52 to -0.30] [n = 1 study]), nocturia (WMD, -0.76 times per evening [95% CI, -1.22 to -0.32] [n = 10 studies]), and improvement in self-rating of urinary tract symptoms; risk ratio for improvement (1.72 [95% CI, 1.21-2.44] [n = 6 studies]), and peak urine flow (WMD, 1.93 mL/s [95% CI, 0.72-3.14] [n = 8 studies]). Compared with men receiving finasteride, men treated with S repens had similar improvements in urinary tract symptom scores (WMD, 0.37 International Prostate Symptom Score points [scale range, 0-35] [95% CI, -0.45 to 1.19] [n = 2 studies]) and peak urine flow (WMD, -0.74 mL/s [95% CI, -1.66 to 0.18] [n = 2 studies]). Adverse effects due to S repens were mild and infrequent; erectile dysfunction was more frequent with finasteride (4.9%) than with S repens (1.1%; P<.001). Withdrawal rates in men assigned to placebo, S repens, or finasteride were 7%, 9%, and 11%, respectively., Conclusions: The existing literature on S repens for treatment of BPH is limited in terms of the short duration of studies and variability in study design, use of phytotherapeutic preparations, and reports of outcomes. However, the evidence suggests that S repens improves urologic symptoms and flow measures. Compared with finasteride, S repens produces similar improvement in urinary tract symptoms and urinary flow and was associated with fewer adverse treatment events. Further research is needed using standardized preparations of S repens to determine its long-term effectiveness and ability to prevent BPH complications.