Reoperation was significantly higher with TUMT (9.9%) compared to TURP (2.3%). The review team worked closely with the Panel to refine the scope, key questions, and inclusion/exclusion criteria. The expert Panel examined three overarching key questions for pharmacotherapeutic, surgical and alternative medicine therapies: (1) What is the comparative efficacy (the extent to which an intervention produces a beneficial result under ideal conditions such as clinical trials) and effectiveness (the extent to which an intervention in ordinary conditions produces the intended result) of currently available and emerging treatments for BPH? Despite the variability and limitations stated above, the Panel attempted to provide some evidence of retreatment rates for the majority of the modalities included in this Guideline. Tubaro A, Carter S, Hind A et al: A prospective study of the safety and efficacy of suprapubic transvesical prostatectomy in patients with benign prostatic hyperplasia. Data Synthesis and Analysis. J Urol 1984; Gades NM, Jacobson DJ, McGree ME et al: Dropout in a longitudinal, cohort study of urologic disease in community men. J Cataract Refracr Surg 2006; 32: 1336. After review of the recommendations for diagnosis published by the 2005 International Consultation of Urologic Diseases12 and reiterated in 2009 in an article by Abrams et al (2009), the Panel unanimously agreed that the contents were valid and reflected "best practices". Rating the quality of evidence. McConnell JD, Roehrborn CG, Bautista OM et al: The long-term effects of doxazosin, finasteride and the combination on the clinical progression of BPH. During this timeframe, any anticoagulant therapy that may have been discontinued will have resumed and be in effect, thereby making the reduction in eschar a significant benefit.314,359-364, The safety of thulium in anticoagulated patients has been reported in several publications. There was no significant difference in changes in any of the ejaculatory domains among men assigned to doxazosin as compared to placebo. 66. When body of evidence strength Grade C is used, there is uncertainty regarding the balance between benefits and risks/burdens, alternative strategies may be equally reasonable, and better evidence is likely to change confidence. 39. Based on the lack of peer-reviewed publication in the literature review timeframe and TUNA’s substantially diminished clinical relevance, the Panel does not recommend TUNA. Urology 2000; Hammadeh MY, Fowlis GA, Singh M, Philp T: Transurethral eletrovaporization of the prostate-a possible alternative to transurethral resection: a one year follow-up of a prospective randomized trial. J Urol 2017; McVary KT, Roehrborn CG: Three-year outcomes of the prospective, randomized controlled Rezum System study: convective radiofrequency thermal therapy for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia. (Conditional Recommendation; Evidence Level: Grade C). Patients with symptoms from an elevated PVR (i.e., overflow incontinence, bladder stones, UTI, upper tract deterioration), may need to proceed on to surgery or for further urodynamics testing. Clinicians are often asked if there is merit to the use of combination of low-dose daily tadalafil with alpha blockers. and IPSS: The administration of the IPSS is recommended at each time point of follow-up as it enables a conversation about expectations and satisfaction and may lead to changes in treatment. The review team also reviewed articles for inclusion identified by Guideline Panel Members. Ann Pharmacother 2000; Roehrborn CG, Van Kerrebroeck P, Nordling J et al: Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. 102. However, further studies are needed to determine whether combination therapy enhances the symptom response, or if the response is driven by the alpha blocker alone. Other interventions include avoiding constipation, increasing physical activity, weight loss, Kegel exercises at time of urinary urgency, timed voiding regimens, and double-voiding techniques.25 Pelvic floor muscle training, including biofeedback, may be helpful for patients with urgency and storage symptoms.26. Because prevalence of LUTS increases with age, the burden and number of men complaining of LUTS will rise with the increasing life expectancy and growth of our elderly population. J Urol 2000; 163: 496. What are the predictors of beneficial effects from treatments? Asian J Urol 2021; Ganesan V, Steinberg RL, Garbens A et al: Single-port robotic-assisted simple prostatectomy is associated with decreased post-operative narcotic use in a propensity score matched analysis. Traditionally, the primary goal of treatment has been to alleviate bothersome LUTS that result from BPO. (Moderate Recommendation; Evidence Level: Grade C), TUIP should be offered as an option for patients with prostates ≤30cc for the surgical treatment of LUTS/BPH. Precision (degree of certainty around an estimate assessed in relationship to MDD); and 5. In the PLESS study, sexual adverse events were reported more frequently with finasteride (15%) than placebo (7%) during the first year of the study (p<0.001); however, no between-group difference was noted in the incidence of new sexual adverse events (7% in both groups) during years 2 through 4.136 Study discontinuation due to sexual adverse events occurred in 4% of finasteride patients and 2% with placebo. They were criticized on account of the relatively short duration of only one year and the fact that patients were enrolled regardless of prostate size and serum PSA leading to a study population of, at, or below average sized prostates and serum PSA values. One of the early intraprostatic effects of finasteride has been the suppression of vascular endothelial growth factor (VEGF).20,346-348 Initially anecdotally,349 and then in long-term follow-up studies350-352 it was noted that men with prostate-related bleeding (i.e., all other causes of hematuria had been excluded) responded to finasteride therapy with a reduction or cessation of such bleeding and a reduced likelihood of recurrent bleeding. LUTS may be due to structural or functional abnormalities in one or more parts of the lower urinary tract that comprises the bladder, bladder neck, prostate, distal sphincter mechanism, and urethra. Urology 2002; Toren P, Margel D, Kulkarni G, et al: Effect of dutasteride on clinical progression of benign prostatic hyperplasia in asymptomatic men with enlarged prostate: a post hoc analysis of the REDUCE study. N Engl J Med 1998; Boyle P, Gould AL, Roehrborn CG: Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Prog Urol 2005; Hahn RG, Fagerstrom T, Tammela TL et al: Blood loss and postoperative complications associated with transurethral resection of the prostate after pretreatment with dutasteride. J Urol 2008; 179: 610. It is also evident that patients with higher baseline IPSS require greater changes to achieve similar levels of satisfaction. Am J Manag Care 12 2006; Wei J, Calhoun E, Jacobsen S: Urologic diseases in America project: benign prostatic hyperplasia. MTOPS showed the risks of AUR and need for invasive therapy were significantly reduced by combination therapy of doxazosin and finasteride (p<0.001) and finasteride monotherapy, (p<0.001), but not by doxazosin, alone. Please see the accompanying algorithm for a summary of the procedures detailed in the Guideline. The mechanism of action of this PDE5 effect is only partially understood. In a multivariable regression, patients who took 5-ARIs had higher prostate cancer-specific (subdistribution hazard ratio [SHR]: 1.39; 95%CI: 1.27, 1.52; P <.001) and all-cause (HR: 1.10; 95%CI: 1.05, 1.15; P <.001) mortality. Scand J Urol Nephrol 2005; Hahn RG, Fagerstrom, T., Tammela, T. L., Van Vierssen Trip, O., Beisland, H. O., Duggan, A. and Morrill, B.: Blood loss and postoperative complications associated with transurethral resection of the prostate after pretreatment with dutasteride. 34. Cheung C, Awan M, Sandramouli S: Prevalence and clinical findings of tamsulosin-associated intraoperative floppy-iris syndrome. The following represents a synopsis of their findings and recommendations of the NIDDK Prostate Research Strategic Plan.102. Withdrawals due to adverse events in the combined group were slightly higher (low certainty).197-199, One large trial compared add on fesoterodine 4 or 8 mg and alpha blocker to placebo and alpha blocker over 12 weeks. A hiperplasia prostática benigna (HPB) refere-se à proliferação de músculo liso e células epiteliais da próstata. Other lasers, such as various diode wavelengths, are also available on the market. Like Nd:YAG, the depth of penetration is deeper than PVP. Before starting a 5-ARI, clinicians should inform patients of the risks of sexual side effects, certain uncommon physical side effects, and the low risk of prostate cancer. The key questions were divided into two topics for medical management of BPH: 1. J Endourol 2002; Brehmer M, Wiskell H, Kinn AC: Sham treatment compared with 30 or 60 min of thermotherapy for benign prostatic hyperplasia: a randomized study. High-grade cancer (Gleason score sum 8) was more common in the dutasteride group (0.36% versus 0.03%).131, CombAT was a 4-year randomized double-blind parallel group study in 4,844 men ≥50 years of age with clinically diagnosed moderate to severe BPH, IPSS ≥12, prostate volume ≥30 mL, and serum PSA 1.5-10 ng/mL. Baile A, Asua J, Albisu A. Hiperplasia benigna de próstata. Finally, managing patient expectations is variable among prescribers. Urol Int 2011; McVary KT, Gange SN, Gittelman MC et al: Minimally invasive prostate convective water vapor energy ablation: a multicenter, randomized, controlled study for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. The tadalafil group had a greater mean change in the BPH Impact Index versus placebo, exceeding the minimal detectable difference of 0.4 points (MD: -0.6 points; 95%CI: -0.81, -0.37).170-175,178 Four trials reported little to no difference between groups in frequency of nocturia (MD: -0.13 times per night; 95%CI: -0.26, 0.01).170-174 It should be noted that nocturia is the one component of the IPSS least likely to improve with any medical treatment. Defining the clinical phenotype: definitions and their importance, 2. While anticholinergics have been used safely in men with storage LUTS, a PVR should be obtained and the usual precautions for the use of anticholinergic medications (e.g., gastric emptying/ GI motility issues, narrow angle glaucoma) should be followed. J Robot Surg 2021. Euro Urol 2008; Bishop CV, Liddell H, Ischia J et al: Holmium laser enucleation of the prostate: comparison of immediate postoperative outcomes in patients with and without antithrombotic therapy. Younger sexually active men are more likely to discontinue due to EjD; therefore, it would be prudent to select alpha blockers with a low incidence of EjD. J Urol 2000; Stoffel JT, Peterson AC, Sandhu JS et al: Aua white paper on nonneurogenic chronic urinary retention: Consensus definition, treatment algorithm, and outcome end points. Ophthalmology 2007; Nguyen DQ, Sebastian RT, Kyle G: Surgeon’s experiences of the intraoperative floppy iris syndrome in the United Kingdom. Dutasteride, which has activity at more 5-ARI receptors than finasteride, has largely not been implicated. J Clin Endocrinol Metab 1992; Wurzel R, Ray P, Major-Walker K et al: The effect of dutasteride on intraprostatic dihydrotestosterone concentrations in men with benign prostatic hyperplasia. Int J Clin Pract 2012; Cohen S, Werrmann J: Comparison of the effects of new specific azasteroid inhibitors of steroid 5 alpha-reductase on canine hyperplastic prostate: suppression of prostatic DHT correlated with prostate regression. Pooled analysis from 3 studies found the thulium laser and TURP groups had similar reoperation rates (RR: 1.3; 95%CI: 0.2, 11.3). However, studies show the risk of urinary retention to be low in appropriately selected patients. The Panel consensus was that the impact of the combination of low-dose daily tadalafil with finasteride offers little or no advantages in symptom improvement over finasteride alone in the short term. Urology 2019; Hamouda A, Morsi G, Habib E et al: A comparative study between holmium laser enucleation of the prostate and transurethral resection of the prostate: 12-month follow-up. 22. (Expert Opinion), IFIS was first described by Chang and Campbell in 2005 as a triad of progressive intraoperative miosis despite preoperative dilation, billowing of a flaccid iris, and iris prolapse toward the incision site during phacoemusification for cataracts.93 Operative complications in some cases included posterior capsule rupture with vitreous loss and postoperative intraocular pressure spikes, though visual acuity outcomes appeared preserved. Ozdal O, Ozden C, Benli K et al: Effect of short-term finasteride therapy on peroperative bleeding in patients who were candidates for transurethral resection of the prostate (TUR-P): a randomized controlled study. 85. Participants underwent annual PSA measurement and DRE, and prostate biopsies were performed for cause, only. (Moderate Recommendation; Evidence Level: Grade C), Only three new long-term RTCs have examined the side effects of 5-ARIs since the 2010 Guideline, while a variety of observational and retrospective studies have also examined this topic in that timeframe.124,131-134. TURP remains the most frequently taught and utilized procedure for the treatment of symptomatic BPH and the one with which nearly all urologists have experience and ability to perform. Curr Opin Urol 2016; McVary KT and Kaplan SA: A tower of babel in today's urology: Disagreement in concepts and definitions of lower urinary tract symptoms/benign prostatic hyperplasia re-treatment. IPSS change was -8.02 versus -6.19 for placebo (p=0.003).196. Similar to statements in the AUA ED Clinical Guideline, sildenafil improves EF in men with LUTS/BPH with and without co-morbid ED.182, 18. Response to treatment through 3 months, based on an improvement in IPSS of ≥30% or ≥8 points, was significantly greater in the WVTT group (74%) compared to the SHAM group (31%) (RR: 2.4; 95%CI: 1.6, 3.5). 79. High-powered and/or continuous lasers are at higher risk for temperature increases. Variabilidad de práctica y guía de actuación basada en la evidencia científica. JAMA Dermatol 2021; Sajadi KP, Terris MK, Hamilton RJ et al: Body mass index, prostate weight and transrectal ultrasound prostate volume accuracy. 19. Panel Formation. The Panel acknowledges that with a more extensive evaluation, some of these men will be found to have other conditions causing or contributing to their symptoms. 19. Additionally, given the commonly co-morbid conditions of LUTS/BPH and ED, patients should be made aware that tadalafil improves EF in men with LUTS/BPH with and without co-morbid ED with LUTS/BPH. Sotelo R, Spaliviero M, Garcia-Segui A et al: Laparoscopic retropubic simple prostatectomy. Kobayashi S, Tang R, Shapiro E et al: Characterization and localization of prostatic alpha 1 adrenoceptors using radioligand receptor binding on slide-mounted tissue section. Artículo anterior. 36. The weight of the prostate gland in grams without the seminal vesicles can be used as an alternative for prostate volume.30, Since DRE is unreliable in estimating prostate size and serum PSA is only a rough indicator, it appears reasonable to recommend prostate imaging, particularly prior to surgical interventions, given that prostate size may direct the clinician as to which intervention to consider.31 Assessment of prostate size and morphology can be achieved by transrectal or abdominal ultrasonography, cystoscopy, or by cross-sectional imaging using CT or MRI. Urology 2010; Mamoulakis C, Ubbink DT and de la Rosette JJ: Bipolar versus monopolar transurethral resection of the prostate: A systematic review and meta-analysis of randomized controlled trials. The original report linked this condition with the preoperative use of tamsulosin; iris dilator smooth muscle inhibition has been suggested as a potential mechanism.93,94 A meta-analysis revealed tamsulosin carried the highest risk for IFIS (40x that of alfusozin), but all alpha blockers increase the risk of IFIS to some degree.95 One study revealed that for every 255 men receiving tamsulosin in the immediate preoperative cataract surgical period, one serious complication (e.g., retinal detachment, lost lens or lens fragment, endophthalmitis) would result.96 Discontinuation of tamsulosin 4 to 7 days prior to cataract surgery is routine practice, but it does not completely eliminate IFIS risk.97, Urologists initiating alpha blocker therapy should inquire about the presence of cataracts or plans for future cataract surgery. Eur Urol 2011; Sarkar RR, Parsons JK, Bryant AK et al: Association of treatment with 5α-reductase inhibitors with time to diagnosis and mortality in prostate cancer. Other PDE5 and Alpha Blocker Combinations. Strong Recommendations are directive statements that an action should (benefits outweigh risks/burdens) or should not (risks/burdens outweigh benefits) be undertaken because net benefit or net harm is substantial. BJU Int 2007; 99: 587. (Moderate Recommendation; Evidence Level: Grade B). More specifically, computational biology and genomic factors should be aimed toward understanding drivers of BPH and prostate growth and therapeutic targets. La hiperplasia benigna de próstata (HBP) es el tumor benigno más frecuente en varones mayores de 60 años. While the GOLIATH trial excluded patients with prostate volumes > 80g,50 a newer RCT randomized men with prostate sizes of 80-150g (average 105g) to PVP versus TURP versus HOLEP. JSM 2017; Gacci M, Vittori G, Tosi N et al: A randomized, placebo-controlled study to assess safety and efficacy of vardenafil 10 mg and tamsulosin 0.4 mg vs. tamsulosin 0.4 mg alone in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Reoperation rates for urethral or bladder neck contractures are reported in 7.4% and 8% in two studies with 3-yr follow-up,52,53 and in 1.2% of cases in another series with 5-year follow-up.54 Medical therapy with alpha-blockers was seen in 5/84 patients (5.9%), and with anticholinergics in 1/84 (1.2%) at a mean follow-up of 57 months (+/- 6.8 months and 82% of cohort still reporting). La hiperplasia benigna de próstata (HBP) es el tumor benigno más frecuente en varones mayores de 60 años. In the development of the current Guideline, the Panel again searched for studies meeting the updated inclusion criteria, yet none were identified. A hiperplasia prostática benigna (HPB) é uma das doenças benignas mais comuns em homens e pode causar o aumento benigno da próstata, obstrução prostática benigna e/ou sintomas do trato urinário inferior ("lower urinary tract symptoms " - LUTS). J Endourol 2000; 14: 757. Las ratas se distribuyeron en 6 grupos: control negativo y positivo . Need for blood transfusion post-operatively seems to favor bipolar TURP, although two out of six meta-analyses revealed no statistical significance. 74. Models could include population science, the development of registries, and analysis of electronic medical records and insurance databases. A statement, achieved by consensus of the Panel, that is based on members clinical training, experience, knowledge, and judgment for which there may or may not be evidence in the medical literature. TUMT is a process whereby coagulation necrosis of the prostatic tissue is achieved by transferring energy into the tissue and creates heat. J Endourol 2020; Jhanwar A, Sinha RJ, Bansal A et al: Outcomes of transurethral resection and holmium laser enucleation in more than 60 g of prostate: A prospective randomized study. Zhonghua Nan Ke Xue 2002; McConnell J, Wilson J, Goerge F et al: Finasteride, and inhibitor of 5α-Reductase, suppresses prostatic dihydrotestosterone in men with benign prostatic hyperplasia. Gisleskog PO, Hermann D, Hammarlund-Udenaes M et al: The pharmacokinetic modelling of GI198745 (dutasteride), a compound with parallel linear and nonlinear elimination. One study has shown that with this approach, efficacy is maintained, while postoperative narcotic use is reduced.249, 30. J Pharmacol Exp Ther 1997; 282: 1496. The generally accepted minimum threshold voided volume for adequate interpretation is 150cc, and patients should be instructed not to Valsalva void. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. 5-ARIs alone or in combination with alpha blockers are recommended as a treatment option to prevent progression of LUTS/BPH and/or reduce the risks of urinary retention and need for future prostate-related surgery. Carter A, Sells H, O'Boyle P: High-power KTP laser for the treatment of symptomatic benign prostatic enlargement. 34. For blinding of outcome assessment and incomplete outcome data the review team assessed ROB for short-, intermediate-, and long-term follow-up. Men who underwent treatment with the older 80W platform have been shown to have higher rates of retreatment for LUTS/BPH as compared to TURP (RR: 2.0; 95%CI: 1.01, 3.8). Download. BJU Int 2012; Telli O, Okutucu TM, Suer E et al: A prospective, randomized comparative study of monopolar transurethral resection of the prostate versus photoselective vaporization of the prostate with GreenLight 120-W laser, in prostates less than 80 cc. Eur Urol 2009; Roehrborn CG, Kaplan SA, Kraus SR et al: Effects of Serum PSA on Efficacy of Tolterodine Extended Release With or Without Tamsulosin in Men With LUTS, Including OAB. For ultrasound measurements it does not matter if the height is measured in the axial or midsagittal image.34, 6. BJU International 2012; Bozzini G, Seveso M, Melegari S et al: Thulium laser enucleation (ThuLEP) versus transurethral resection of the prostate in saline (TURis): a randomized prospective trial to compare intra and early postoperative outcomes. McConnell J, Wilson J, Goerge F et al: Finasteride, and inhibitor of 5α-Reductase, suppresses prostatic dihydrotestosterone in men with benign prostatic hyperplasia. The procedure is generally performed with saline irrigation, eliminating the possibility of TUR syndrome that can occur with non-ionic irrigation. Eur Urol 2006; Geavlete B, Bulai C, Ene C et al: Bipolar vaporization, resection, and enucleation versus open prostatectomy: optimal treatment alternatives in large prostate cases? (Strong Recommendation; Evidence Level: Grade A), In the 1990s, two studies of 12 months duration were conducted testing the hypothesis that combination medical therapy may be superior to monotherapy.183,184 The VA CO-OP used placebo versus terazosin 10mg versus finasteride 5mg versus combination, and the European PREDICT trial used doxazosin instead of terazosin. This includes Nd:YAG, which is preferentially absorbed by hemoglobin and has a depth of penetration of approximately 1 cm. Definitions of and outcomes for subjective symptom response varied substantially between trials. In one trial with a moderate ROB and 281 participants who were randomized to tadalafil or placebo after a 4-week placebo run-in period, participants randomized to tadalafil started at a dose of 5 mg daily and were escalated to a dose of 20 mg daily after 6 weeks.170 At 3 months, participants in the tadalafil group on the 20 mg dose had a greater response to treatment, defined as a change from baseline of ≥3 points in IPSS, compared to placebo, 61% versus 43% ([RR: 1.43; 95%CI: 1.13, 1.80]; [ARD: 18%; 95%CI: 7, 30]; Number Needed to Treat [NNT]=6). At the primary double-blind period of three months, only one participant in the thermal therapy group required a reoperation due to LUTS.67-70 At 4 years follow up, the reported retreatment rate had increased to 9.6% (6 subjects underwent procedural interventions, while 7 were on medical therapy). 75. However, the IPSS improvement in men with combined alpha blocker and anticholinergic compared to alpha blocker alone is variable. (Moderate Recommendation; Evidence Level: Grade B), TUIP has been used to treat small prostates, usually defined as ≤30g, for many decades. The risks of AUR and the need for invasive therapy were significantly reduced by combination therapy (p<0.001) and finasteride (p<0.001) but not by doxazosin. This lack of agreement may potentially lead to misinterpretation of data or bias in assessing retreatment outcomes between different trials and therapies.40 The field of BPH clinical research would benefit from development of an evidence-based and universally employed classification system for retreatment, which would provide urologists and patients with critical and transparent evidence of retreatment risk before determining the best clinical approach. 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