Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. OB)-A pnlblrnoie otoldciia study. clinical SINGH controlled IQBAL randomised label open An symptoms - bladder (OABS) overactive coexisting Hyperplasia predominantly prostatic with benign (BPH) of with management combination the its in versus mirabegron tamsulosin of safety and Efficacy aslsnvru iaerncmiaind-ooteayfrBHwt rdmnnl oxsigOABS. coexisting AFFILIATIONS predominantly with AND BPH AUTHORS for therapy de-novo combination mirabegron benign versus Tamsulosin of management the TITLE in RUNNING open mirabegron (OABS)-An study. symptoms with clinical bladder combination controlled overactive randomised coexisting its predominantly label versus with (BPH) tamsulosin Hyperplasia of prostatic safety and Efficacy tolerability and OABS. compliance coexisting/predominant better BPH effects, TITLE with side of patients minimal Mirabegron- protocol. safety, of initiating therapy overall subset on by select of add enhanced the usual terms safely in the in particularly to be superior monotherapy opposed can Tamsulosin be as versus efficacy patients to This virgin appeared medication combination in placebo. start This versus the and were BPH from and efficacious by therapy self-limiting significantly combination induced minor, was Tamsulosin were OABS Mirabegron TEAE ameliorating The CONCLUSION: in discontinuity. retention. urinary treatment safe developed any IPSS- patient without (p IPSS, no symptomatically episode/night, and indices voiding arm managed (QOL) in Mirabegron Life change the of mean in the Quality observed was as -2.22p and such vs Qmax, -5.62 parameters OABS volume/micturition, difference secondary voided (mean total the group ss,OABS-ss, frequency of endpoint combination most the primary the with in in the by seen weeks were in change 8 assessed improvements registry of was visualised mean trials end safety were clinical (OABSS), the improvements while at the Score (OABSS-ss) Significant with (IPSS) subscore OABS RESULTS: prospectively score registered the symptom was (CTRI/2018/12/016541). using protocol prostate India evaluated The international of (TEAE). arm)] was and events adverse Efficacy (PVR) (Comparator emergent residue lactobacillus treatment weeks. void recording capsule 8 post plus voiding, of mg nocturnal period uncomplicated 0.4 of a of [Tamsulosin patients for arm)]or daily 80 (Intervention once clearance, mg of ethics 0.4 IPSS institutional Tamsulosin symptoms and and Mirabegronplus bladder OABS overactive consent predominantly coexisting informed coexisting with written with BPH patients prior BPH After tamsulosin-placebo virgin versus medication METHODS: therapy of (OABS). combination subset Mirabegron-Tamsulosin select of a analysis in efficacy-safety monotherapy an do to aim We PURPOSE: Abstract 2020 11, December 3 2 1 nvriyCleeo eia cecs&GBHospital Hospital GTB available GTB & not & Sciences Affiliation Delhi) Medical of of (University College Sciences University Medical of College University 1 iy Behera Dibya , > 2 eecmue admzdadalctdt eev hrp ihete [50mg either with therapy receive to allocated and randomized computer were 7 rvn TK Aravind , 1 3 n ajyGupta Sanjay and , < .0) osgicn nraei PVR in increase significant No 0.001). 3 < .0)Smlrsignificant 0.001).Similar Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. a ensaigyasse ntepbihdEgihltrtr.W i od necc-aeyaayi of analysis (OABS). of efficacy-safety symptoms subset an bladder overactive do select predominantly to a coexisting aim mg) in with We 50 monotherapy patients literature. (Mirabegron virginBPH tamsulosin-placebo English agonists medication versus published ofBeta-3 therapy the safety combination in and Mirabegron-Tamsulosin assessed efficacy sparingly The been hyperplasia. has prostatic benign to (LUTS)due PURPOSE: ABSTRACT [email protected] E-mail: (Fax) 91-11-22590495 91-9810499222(Mob); 91-11-22586262(Off), Tel: India Delhi-110049. New Delhi). NDSE-2, of F-14 (University Sciences, Medical of Surgery, College of University Department Urologist, Consultant USA. Senior NC, and WFUMS, Professor Urology), Invasive Minimally & (Robotics Fellowship Singh Iqbal Dr. Delhi-95. Hospital, ADDRESS GTB & & Delhi) AUTHOR of CORRESPONDING (University Sciences Medical of College University (Urology*) Surgery of Department GTB & Delhi) INSTITUTION of (University Sciences [email protected] Medical Email: of College India University Delhi-95. Surgery, Hospital, of Department Affiliation: Gupta Sanjay Name: GTB https://orcid.org/0000-0002-6501-5014 & ID: Delhi) ORCID of (University Sciences [email protected] Medical Email: of College India University Delhi-95. Surgery, Hospital, of Department Affiliation: T.K Aravind Name: GTB https://orcid.org/0000-0001-7672-904X & ID: Delhi) ORCID of (University [email protected] Sciences mail: Medical E of College India University Delhi-95. Surgery, Hospital, of Department Affiliation: Behera Priyadarsini Dibya Name: https://orcid.org/0000-0001-8743-3404 ID: ORCID Delhi) [email protected] of Email: (University Sciences India Medical Delhi-95. of Hospital, College University GTB (Urology*), & Surgery of *Department Affiliation: Singh* Iqbal Name: ueosteaetcotoseiti h aaeeto oe rnrtatsymptoms urinarytract lower of management the in exist options therapeutic Numerous * , .h(rlg) .. GSr) S N (Surg) DNB MS, (GUSurg), D.N.B (Urology), M.Ch 2 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. nptet fBHwt soitdOB fe h nta u nteaywt lh lcesi already is symptoms blockers storage alpha residual with of therapy to? management in add run the article this initial for literature does the therapy English What after on published OABS the add in associated an well with reasonably as frequently BPH documented the mirabegron of OABS of of patients of profile efficacy management in effect adverse the The troublesome for the approved 2. of agonist lack beta-3 and novel action drugs. a of anti-cholinergic mechanism mirabegron, utilized unique on its is to limelight owing SG shining up. The follow and topic? wrote 1. care DPB this manuscript. patient & this about day IS of to known day draft data. enrolled already in final patient patients involved What’s the collected the were co-approved DPB of DPB and and care manuscript. ATK study overall the the manuscript. the this of the co-supervised of draft supervised of in-charge final draft who also the first was surgeon/urologist approved the and and consultant study study faculty this this responsible of in protocol the the was designed IS study, – contributions N/A Authors’ – material and data of Availability Nil - interests interest/Competing of Conflicts Funding–N/A BPH with DECLARATIONS: protocol. of patients therapy’ of on compliance subset ‘add WORDS better select KEY usual effects, the side the minimal in combination safety, to particularly overall Mirabegron-Tamsulosin opposed OABS. monotherapy of initiating coexisting/predominant Tamsulosin terms as in versus by patients superior tolerability enhanced virgin be and medication safely to appeared in be combination start This can the efficacy from minor, This therapy were TEAE placebo. The versus retention. discontinuity. urinary treatment developed any CONCLUSION: patient without voided no symptomatically OABS-ss, and managed were (p arm IPSS-ss, and indices Mirabegron IPSS, self-limiting combination (QOL) the episode/night, the Life in voiding in observed of in weeks was Quality change 8 and mean of Qmax, the end volume/micturition, as the such at -2.22p parameters visu- (OABSS-ss) vs the were secondary OABSsubscore improvements -5.62 with total Significant difference parameters (mean endpoint score(IPSS-ss). efficacy group primary sub baseline storage the and IPSS in volume and alised prostate frequency (PSA), nocturnal antigen of exception specific (CTRI/2018/12/016541). prostate India function, of renal registry trials clinical the RESULTS: with prospectively registered in done was were change visits protocol mean up Follow The (OABSS), (TEAE). (IPSS) Score events score adverse OABS emergent symptom 2 usingthe treatment prostate at recording evaluated andinternational by was (PVR) assessed residue Efficacy was arm)] safety void weeks. (Comparator while post 8 lactobacillus voiding, ofnocturnal of capsule frequency Mirabegronplus plus period the either[50mg a mg with for 0.4 therapy [Tamsulosin daily receive arm)]or once to (Intervention allocated mg and 0.4 randomized Tamsulosin of computer IPSS were and therapy OABS drug coexisting with BPH complicated METHODS: Ti aucitatmt oetbihteecc n aeyo iaerntmuoi combination mirabegron-tamsulosin of safety and efficacy the establish to attempts manuscript This 1. nd inwt smtmtcBHwt rdmnnl oxsigOB’a env hrpui measure. popula- therapeutic De-novo Indian a of as subset OABS’ a coexisting in predominantly monotherapy with blocker BPH alpha ‘symptomatic tamsulosin with tion used routinely the versus therapy 4 , th n 8 and ainsi ohgop eecmaal nbsso hi eorpi aa preoperative data, demographic their of basis on comparable were groups both in Patients fe ro rte nomdcnetadisiuinlehc laac,8 ainso un- of patients 80 clearance, ethics institutional and consent informed written prior After iaern aslsn einPott yepai,Oeatv lde Symptoms. Bladder Overactive Hyperplasia, Prostate Benign Tamsulosin, Mirabegron, : th ek otteayaddt a nlsduigteSS vr23 SPSS the using analysed was data and therapy post weeks iaernwssgicnl ffiaiu n aei mloaigOB nue yBPH by induced OABS ameliorating in safe and efficacious significantly was Mirabegron < .0)Smlrsgicn mrvmnswr enwt oto the of most with seen were improvements significant 0.001).Similar 3 > ihu eia otaniain oteplanned the to contraindications medical without 7 . < .0) osgicn nraei PVR in increase significant No 0.001). IMCorp) (IBM sprprotocol. per as Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. h ffiayo iaerna nado ps lh lce hrp)mngn eiulsoaeLT in LUTS storage residual managing therapy) blocker alpha OABS (post residual on co-existing add with an OABS patients as ameliorating BPH Mirabegron and of capacity efficacy storage the its significant increasing to thereby leading phase retention urinary accompa- and albeit constipation OABS’ α- mouth, induced dry ‘BPH like discontinuity for events drug therapy adverse of bothersome stay by main nied the were drugs bladder antimuscarinic increased Traditionally OABS. progressively secondary accommodate to inducing inability sensation an and being of denominator filling phase common the storage with the OABS and during OABS contractions predominant/coexisting detrusor have inappropriate OABS and producing patho-physiological micturition activity similar the over by detrusor induced urgency LUTS in as storage culminating defined with infection proven was overlap any (OABS) frequently without symptoms causes nocturia OABS symptoms micturition and bladder pathology. frequency post increased overactive obvious with and which or usually incontinence voiding in urge without storage, factors or into aetiological with OABS their divided on had based society continence International INTRODUCTION oiiito fteay h ffiayotoemauewseautdb siaigteOABSS(primary the estimating by evaluated was measure prior outcome LFT, (D0) efficacy (hemogram, visit would initial with The any the protocol during if therapy. uroflow) per effects and as of side KUB+PVR two evaluated major initiation ultrasound were of their ECG, Patients capsule to and period culture, plus arms routine, frame). study urine the mg time for and both study 0.4 KFT meals in this (Tamsulosin after drugs within (II) of bedtime exhibited (Tamsu- action group at be of (I) comparator administered onset group the medications rapid intervention or (considering the the months tablet) with either from capsules) Mirabegron history to excluded 1 50mg prior allocated were lactobacillus plus and with bladder mg randomised Patients neurogenic 0.4 computer or losin were surgery). pro- diseases Patients for medication, prostate study. administered indication concomitant this to absolute andother interference any surgery metabolic diagnosed or with static/urethral (newly IPSS therapy therapy criteria an drug drug inclusion anaphylaxis/hypersensitivity, and with planned protocol of OABS BPH predominant the per of with as patients to size consenting treat, cations any and to of eligible intent BPH 80 primary uncomplicated on the performed with with was OABS study BPH predominantly control of randomised prospective patients A select novo therapy. in de METHODS run AND in blockers MATERIALS alpha tamsulosin0.4mg) prior + without OABS 50mg coexisting (Mirabegron predominantly therapy combination of lcesfralvaig‘P nue AS htatb eaigtebadrdtuo ntestorage the in detrusor bladder the relaxing by act that OABS’ induced ‘BPH alleviating for blockers 1 Tecretrslso hsrsac dst h lrt nteltrtr n teghn h oinof notion the strengthens and literature the in clarity the to adds research this of results current The 3. of occurrence any of was there whether investigating on closely focuses especially also manuscript This 2. rtcli aoiyo ainso LT u oBHwt AS.Ti esr nisl snovel is the itself in in on utility measure add mirabegron’s OABS. This employed towards with OABS’. usually urologists BPH with the practicing of BPH patients to of symptomatic to opposed perception of due as global management ‘LUTS retention medical the of urinary change patients inducing and to of of PVR attempt fear majority of apparent the in incidence without protocol the therapy in start-up a rise the as therapy any therapy about on combination ambiguous add is mirabegron PVR utilizing the on without effect OABS’ its and with mirabegron BPH regarding to literature same. current due the mirabegron ‘LUTS initial as of for protocol use concomitant therapy the with combination specifically –tamsulosin as associatied retention, OABS’ urinary with and fashion therapy. PVR BPH therapy rising blocker on to add alpha due an post in ‘LUTS symptoms mainly of BPH-OAB mirabegron patients utilising residual research select manage published therapy virgin to of combination naive majority mirabegron-tamsulosin medicine the using to in of opposed utility start de-novo the unique from its initially for novel is article This 1 nodrmn P ihLT n hoi btuto nue hne ndtuo muscle detrusor in changes induces obstruction chronic and LUTS with BPH men, older In . 4 iaerni ee eetv ea3aoitta a entidi obnto with combination in tried been has that agonist beta-3 selective newer a is Mirabegron . 2 rud5-5 fedryml ainso P ihLT perto appear LUTS with BPH of patients male elderly of 50-75% Around . 3 hsteeeit omnuiyn atraogtBH LUTS BPH, amongst factor unifying common a exists there Thus . 8,9 eenw tep oaayeteecc n safety and efficacy the analyse to attempt we Herein . 4 ,6 5, > ihu n eia contraindi- medical any without 7 oesuishv documented have studies Some . Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. p ihrsett mrvmn nOBSadIS nldn h trg u cr IS-)a e higher per as (IPSS-S) score sub storage the (-9.40 including IPSS-S IPSS monother- and the Tamsulosin OABSS in to in improvements superior improvement was to Tamsulosin respect with with Mirabegron apy of therapy combination study, present In therapy. administered the re- to II compliance and DISCUSSION I complete nor groups symptomatically was (p=0.136) managed in There and 1 PVR discontinuity. self-limiting and in drug minor 2 increase were without 80(3.8%), which significant of (tachycardia/headache) any arm.Three TEAE intervention reveal had and the statistically spectively) not (AUR)in Qmax did Retention was Urinary study volume/micturition, there Acute our any voided that intake, OABS-SS, Mirabegron 1b) of IPSS-S, (Table complication IPSS, data (Mean treatment episode/night, group (p intervention voiding post QOL the in the in change of parameter) [mean outcome terms -2.22p (primary vs In (p score -5.62 nocturia OABS difference of 0.001. the exception = of the respec- improvement with p 1(b) significant parameters and (SS), most 1(a) Table in IPSS in comparable and depicted was group). are data each parameters pre-treatment in post-treatment the tively, subjects and pre- (40 patient 80 demographic of Salient size sample study a incorporated We RESULTS group. per the 20 in about (SD) was deviation standard a and considering 12.33 study) 90% of the completed rate (76 flow randomised peak were patients 94 calculation which in size &sample was data factor Continuous Power worksheet. Excel data. MS the categorical in the recorded analyse was Student’s data unpaired The by USA. analysed York, the New at IBM, 23.0 visits version up follow Analysis with (secondary TEAE IPSS Statistical therapy and post PVR for frequency, monitoring voiding by 2 nocturnal assessed change was parameters).Safety mean efficacy the by parameter)followed outcome namt-nlssadssei eiwo he Cscmrsn 37ptet odce ySuy tal et Shunye by conducted patients 1317 comprising RCTs three of -2.78/ review IPSSof systemic respectively and total groups meta-analysis the study. Tamsulosin+placebo) a present and and In the OABSS addon with in (Mirabegron harmony change the in mean in was respectively the (p which -4.25 in respectively -2.13/ groups difference tamsulosin(0.2mg) (Tamsulosin+placebo) and episodes/24hrs significant initial and -2.13 micturition a add-on of in established weeks Mirabegron change also the 4 mean in authors after the -0.75 to in and treatment difference -1.27 add-on significant by an a as demonstrated OABS line They controlling monotherapy. Tamsulosin in in was the safe which and in group effective -2.21 add-on similar al and Mirabegron with et the -0.87 Kakizaki along in by period(p=0.012) index study. OABSS week QOL present overall and eight the IPSS-S the an with the over in demonstrated in respectively change improvements authors group significant These mean patients. combination the BPH and symptomatic in monotherapy in difference therapy Tamsulosin significant of a therapy 0.2mg blocker after literature. alpha OABS English summary dual the in a in run al depicts published this).Table-2 et initial to studies Ichihara an attributed similar be of of disruption. could features need study possibly salient PVR/AUR the any of in without review mo- increase without tamsulosin of OABS and lack versus induced desirable safe minor (the BPH and were improving efficacious effects considered in TEAE/side be notherapy could arm. therapy intervention combination the Mirabegron-tamsulosin in observed was nd 4 , th < n 8 and α .0).A poe oohrpbihdsuisdpcigaueuiayrtnin(U)a major a as (AUR) retention urinary acute depicting studies published other to opposed As 0.001)]. %hne oetmt hsdffrnei envle h eust apesz o significance for size sample requisite the value, mean in difference this estimate to hence, 5% = 7 8 th eosrtdteecc n aeyo 0gMrbgo sa d-ntetetfrresi- for treatment add-on an as Mirabegron 50mg of safety and efficacy the demonstrated naohrrnoie lcb-otoldsuydmntae htMrbgo 5m)was (50mg) Mirabegron that demonstrated study placebo-controlled randomized another in ekps ntaino hrp.Fg1dpcsflwo h urn td protocol. study current the of flow depicts Fig-1 therapy. of initiation post week : ttsia nlsswspromduigSaitclPcaefrteSca Sciences Social the for Package Statistical using performed was analysis Statistical ± < .2i aslsngopad10.5 and group tamsulosin in 1.22 .0) iia mrvmnswr eni otscnayotoeparameters outcome secondary most in seen were improvements Similar 0.001). P t < etwieteCisur etadRpae esr NV a sdto used was ANOVA measure Repeated and test Chi-square the while test 0 a osdrdsaitclysignificant. statistically considered was .05 ± .7vs-4.60 2.57 : ae nasmlrpbihdcmaaiesuyb ciaae al et Ichihara by study comparative published similar a on Based ± .5 n otra rqec (-5.05 frequency nocturnal and 2.35) 5 ± .9i h iaerngopwt oe = Power with group Mirabegron the in 1.79 ± .8vs-1.57 1.78 < .0) The 0.001). < ± 0.001) 1.38) 10 7 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. ypos nipoigtencunlfeunyi ainso P hc per ob h oebothersome LUTS core residual the with be -5.05 tamsulosin males to was with appears post 30% frequency which for BPH about Mirabegron of protocol of patients in efficacy therapy in the frequency symptom on compare nocturnal to add the RCT improving such using in first symptoms) (without the is tamsulosin-placebo study present with literature. the be combination literature the could of in search study the published on present mirabegron obstruction/urethral Based Tamsulosin the on outlet of in RCTs various bladder IPSS-V action in the to of (OABSS/IPSS) in mechanism due parameters groups with the mainly within harmony by are observed in explained change dysfunctions was significant which voiding The placebo and abnormalities. versus muscle Mirabegron smooth by detrusor study unaffected present studies was basis the management similar the (IPSS-V) in the on other However score for monotherapy. IPSS-S, efficacious sub tamsulosin considered and voiding versus be IPSS OABS the could total predominant/co-existing therapy OABSS, combination with initial the BPH the in of that improvement appeared significant it was which there of study present the In 8.5 (p from therapy theirOABSS add-on in improvement Mirabegron significant groups. a the demostrated both therapy,too Tamsulosin in IPSS score al of OABS et subscore Wada total storage the in improvement that significant demonstrated with authors groupsrespectively These 6.5 was therapy. therapy additional pre/post (50mg) Mirabegron alocating al groups et weeks -0.69 Matsuo placebo) 12 by CIof + study 95% (Tamsulosin prospective a another and with In Tamsulosin) OABSS total + of (Mirabegron difference combination (p mean betweenthe respectively the -0.38) in difference to significant (-1.00 a calculated authors the rae mrvmn ihMrbgo a nacdb h os aeiencunlfeunyosre in observed frequency (5.75 nocturnal arm baseline tamsulosin worse the the versus by group enhanced intervention was the Mirabegron with improvement greater seilyi ihrs ypoai ainsae ? 5yaswt niiilPVR in initial or an monotherapy with years as 75 either of OABS caution [?] PVR with in aged Mirabegron-antimuscarinics baseline patients drugs using symptomatic antimuscarinic higher physicians risk in on with resulted high studies patients has in term data several especially long in recruited void of such had lack and which the combination and studies elucidated 200ml such be many [?] fails to in contractility combination remains synergistic bladder criteria this reduced unison why inclusion to to in related as complications act of of mechanism to rate OABS The the managing symptoms/AUR. impact PVR/voiding for with adversely synergistically increasing to like used PVR appear been in has not agents does decrease antimuscarinic which and numerical Mirabegron of non-significant respectively. combination groups with The placebo study Tamsulosin/ and our increase combination change significant to /Tamsulosin any mean Mirabegron similar with The was associated therapy. not which Mirabegron was (p=0.23) al Mirabegron et Wada that PVR by demonstrated study in a authors In the 2c). (Table OABS BPH-LUTS residual with men in PVR on placebo. effect the versus PVR/AUR significant on Mirabegron a Effect with observed frequency independently Mirabegron researchers for nocturnal these 0.21) the and -0.01(-0.18, respectively in al and placebo decrease 0.00) vs et -0.13(-0.33, Tolterodine the and of Kuo placebo difference deciding vs by mean for adjusted study an score demonstrated placebo-controlled nocturia authors randomized versus another determinant In better a be OABS. may of frequency severity nocturnal in improvement α lce hrp)taie noyugr(57 er)adteodrgop 7-4yaspirto years)prior (75-84 groups older the and years) (65-74 younger into therapy)stratified blocker 1 12 naohrpopciesuycnutdo 6Jpns e ihpritn ASot8weeks 8 OABSpost persistent with men Japanese 26 on conducted study prospective another in < .0)n ocue htMrbgo a neetv ramn o P nue OABS. induced BPH for treatment effective an was Mirabegron that concluded 0.001)and 8,11 : aiu atsuiso iaernhv eosrtdabgosrslsregardingits results ambiguous demonstrated have Mirabegron on studies past Various ± ± hscudb xlie n trbtdt h atta iaernatoson actions Mirabegron that fact the to attributed and explained be could This . .8ad-1.57 and 1.78 2.7/4.4 < .0)wt ocmtn iia mrvmn nteIS n IPSS-S. and IPSS the in improvement similar concomitant with 0.001) ± . p .0)ad5.6 and 0.004) (p= 1.6 ± ± .8i rusIadI epciey ntepeetsuystatistically study present the In respectively. II and I groups in 1.38 Di V norsuyws-7.20 was study our in PVR in SD 16 14 11 hscnuini ute opuddb atta biased that fact by compounded further is confusion This . ntecretsuytema change mean the study current the In . n5 e ihLUTS( with men 50 on 6 13 ± .3v 3.90 vs 2.03 Tbe (-)bifl eit h ain outcome salient the depicts briefly 3(a-b) .Tables ± 1.3/4.2 15 ± odce n12 ASptet the patients OABS 1126 on conducted . (p 1.2 ± > .5 hc perdt ugs that suggest to appeared which 1.35) 5yaswt essetOB post OABS persistent with years 65 12 < .0)fryugradodrage older and younger for 0.001) n2 e ihps tamsulosin post with men 26 on ± 26 028.2i the in 30.2789.62 / 42.66 > 200ml ± ± . o4.7 to 2.3 17 Di nocturnal in SD . ± . with 2.5 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. h bv etoe aaeesa h n ftesuy(F-2.20 (NF in study improvements IPSS- greater the the showed of in group end combination groups the the both at that between comparability fact parameters -9.40 the baseline residual mentioned tamsulosin by in observed above post limitation negated mismatch the Another for was minor omitted. therapy this relative was on However therapy the add ss/NF. tamsulosin was an in study as to run Mirabegron the initial durations conventional of in longer the role and as the any, sizes establish Considering if larger to OABS of data. attempt trials monitoring no future was effect in would There adverse expect study we term data. this recent, safety long relatively of our of be validate findings to absence further major research the safety/efficacy/AUR/PVR of the excluding term area Nevertheless, long this albeit therapy. the this relevance on Mirabegron within However data hold well restrictions. prolonged in rapid protocol exhibited still void with to had be this due any study enhanced would as have the any if any could if in elevation if events study drugs adverse effects of term both duration side long that longer observed the fact evaluate a usually present not the their did the considering study of previously protocol This majority trials described frame. largely this and reasons published in usually action For done other are study. of was of at of onset LUTS up weeks) duration follow prostate bothersome week (12 shorter the that 8 duration our of eight mind question longer stratification in could the Size one bearing Considering concerns. Mirabegron, study size. safety prostate this patient of in and independent omitted considered restrictions was escalation not protocol age Dose was to An robust. limitations. more presentation due study certain this to study co-existing made admit this have we predominantly could study in which with this omitted of was patients size size sample BPH-LUTS sample and stratified of power adequate group the Despite select to Limitations: the appeared were in which Mirabegron aspect discontinuity. reactions safety drug adverse its OABS. any developed (headache) on without group high symptomatically placebo score managed + were Tamsulosin and the self-limiting from patient one and TEAE: (p-0.020). group al et al Ichihara et Similarly, Ichihara by conducted study -2.38 the QOL to similar on and Effect significant was which group, placebo) Q + (Tamsulosin the in change al mean et Kakizaki +placebo). voided losin like parameters (Q uroflowmetry flow in change demonstrated maximum patients also and BPH was trials (VV/micturition) in improvement larger significant volume/micturition (tadalafil) with study like evaluation present drugs further the other merits In however with it, combination LUTS in mirabegron storage used the predominant been that with concluded has and Tamsulosin muscle Though blocker smooth alpha urethral onism. to term mouse the attributed long in was with mirabegron AUR result of in effects increase further the no on is depicting tigated therapy antimuscarinics combination data to this scarce contrast available of in mutual positive term merit therapy in the long The acting by contractility. the thereby explained accumulation, by bladder PVR on enhanced be urine/ effect possibly preventing Mirabegron’s component could to voiding study emptyingantagonism the currents bladder on acts on the and drugs/combination in relaxant both PVR/AUR of the action in antagonistic rise significant of Lack n PSS12.68 IPSS-S and fptet.A euto criyo tde fsmlrntr,ftr tde ftesm aueo larger a on nature same the study. present of the studies of future size findings nature, sample the similar stratified of support age studies to larger of required a scarcity be of of may inclusion result scale by a minimised As been patients. have of could which minor was comparability ± ± .7v -4.60 vs 2.57 (p significantly improved had QOL overall the and respectively 1.00 ± ntepeetsuy w ainsi h iaern+Tmuoi ru haah n tachycardia) and (headache group Tamsulosin + Mirabegron the in patients two study, present the In Di Vmcuiinws129.40 was VV/micturition in SD : ntepeetsuytema hnei O ne nbt rusws-3.05 was groups both in index QOL in change mean the study present the In ± .1v 10.97 vs 2.71 ± .5p 2.35 max 7 β 3 ntersuyosre infiatipoeeti O ne ncombination in index QOL in improvement significant observed study their in , norsuyws-4.04 was study our in < arncpo gns ncmiainwith combination in agonism -adrenoceptor .0)dsieifro aeieprmtrvle N 5.75 (NF values parameter baseline inferior despite 0.001) 8 ± eosrtdsmlrrslsi em fvie ouei hi td.The study. their in volume voided of terms in results similar demonstrated .2 esstecmaao ru.W elta h braino baseline of aberration the that feel We group. comparator the versus 3.02) 19-22 . ± na xeietlsuyb lxnr tal et Alexandre by study experimental an In 4.4(iaern+Tmuoi)ad86.92 and Tamsulosin) + (Mirabegron 149.24 ± .5frtecmiaingopad-0.72 and group combination the for 4.35 7 max nMrbgo d ngop h mean The group. on add Mirabegron in ) 18 ± . .5v -0.70 vs 0.65 aslsnsre sabadrneck bladder a as serves Tamsulosin α < Aand 1A .0)i h obnto group. combination the in 0.001) α D-deoetrantag- -adrenoceptor 1D ± .6p 0.56 23 24,25 ± .3v 3.90 vs 2.03 h uhr inves- authors the ± < 8.9(Tamsu- 288.99 . .0,IPSS-S 0.001, ± .1frthe for 3.51 ± 6 27 26, .5and 0.55 ± 1.35 7 on . Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. REFERENCES TK Aravind https://orcid.org/0000-0001-7672-904X Behera Priyadarsini Dibya https://orcid.org/0000-0001-8743-3404 Singh Iqbal associated interest of conflict IDs: of sources ORCID potential no have publication. and its participants human with Registry Trials in research Clinical for the Standards with registered protocol STATEMENT: its ETHICAL per as study this in India. participants of human the all from research. STATEMENT this CONSENT with INFORMED associated incentive financial or Retention. Specific and Urinary Prostate commercial – Acute PSA – Prostate Urinary subscore; AUR International Lower voiding Index; – DISCLOSURE: IPSS – Life IPSS – LUTS Of IPSS-V Residue; Quality Void subscore; ; – Post storage Symptoms QOL IPSS – Bladder Antigen; – PVR –S Active Infection; IPSS Over Tract Score; Urinary – Symptom – OABS UTI Hyperplasia; Symptoms; Prostatic Tract Benign – BPH a of retention. ABBREVIATIONS fear urinary confounded any ill in the culminating therapeutic without residue start-up ACKNOWLEDGEMENTS OABS void viable coexisting post potential predominantly the poten- a with further in as BPH be rise combination could of in Tamsulosin potential efficacy patients monotherapy with This select tamsulosin Mirabegron tolerability. for versus of good option OABS and utility combina- induced effects the mirabegron side BPH by that minimal ameliorating tiated with conclude in patients confidently our effective that can of and majority we reported safe limitations and was these therapy examined despite tion previously summary with been In BPH has of Conclusions: patients this (darifenacin) select as anti-cholinergics in to effective study; with and compared this safe OABS therapy was effects accompanying in al tamsulosin/darifenacin combination adverse done with et therapy additional mirabegron was combination Shin without OABS initial of weeks, by induced comparison concomitant 26 BPH OABS no without for for with Finally or tolerated study males well IV with 464 was phase placebo. OABS therapy comparison on with mirabegron parallel exclusively and patients that placebo-controlled, AUR conducted their double-blind, of Mirabegron of randomized, study, occurrences multicentre, on majority this the a for in which In effective in BPH BPH. BPH)] without and with OABS well-tolerated al diagnosed of of was et (3176 patients use Takahashi 4540 concomitant in by on the Mirabegron study BPH of marketing [with/without effect post patients the a examine in attempt however not did We Tre H rdn F mohmsl ftebadri h omladtedsae tt:Patho- state: diseased the with and cine/pressure/flow/cystourethrography synchronous normal R. Turner-Warwick the CG, in Whiteside CP, bladder Bates the 3. of muscle Smooth AF. terminol- Brading of standardization WH, The Turner al. 2. et U, Ulmsten P, Rosier D, Griffiths M, Fall L, Cardozo P, Abrams 1. pca eeec osrs n reicniec.B rl 1970;42(6):714-23. Urol. J Br incontinence. urge and stress to reference special 1997;75(2):77–110. Ther. Pharmacol treatment. and diagnosis, physiology, International the of sub-committee 2003;61(1):37–49. standardization the Urology. from Society. Report Continence function: tract urinary lower in ogy https://orcid.org/0000-0002-6501-5014 h uhr ute elr htw aentigt icoeadhv odrc rindirect or direct no have and disclose to nothing have we that declare further authors The 28 . α -lceswr pcfial netgtd h uhr ocue htMirabegron that concluded authors the investigated, specifically were 1-blockers Nil – h uhr elr htteaoemnsrp si opinewt Ethical with compliance in is manuscript above the that declare authors The h uhr locriyta nomdcnetwsobtained was consent informed that certify also authors The : 8 26 sn iaern1 ek hrp o OABS for therapy weeks 12 Mirabegron using 27 h uhr concluded authors the Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. AeadeE,Kgt R amsn B iv H iv P eriaRade lMrbgo re- al.Mirabegron et and R Ferreira KP, Silva FH, bladder Silva overactive FB, for Calmasini therapy LR, add-on Kiguti as EC, Solifenacin Alexandre 23. al. et in oxybutynin Y, extended-release Homma of H, safety Kakizaki and O, Efficacy Yamaguchi 22. to al. therapy et add-on A, solifenacin Chen of tolerability KM, and Peters Safety SA, al. MacDiarmid et 21. R, with Fincher men K, of McCammon treatment SA, for Kaplan tamsulosin and 20. Tolterodine the al. in et tamsulosin ES, of Rovner outcomes CG, Urodynamic Roehrborn NS. SA, Overactive Kekre Treat Kaplan B, to Kumar 19. Solifenacin S, Kumar to AD, Mirabegron Dangi Adding MK, al. Sudrania et 18. S, the Al-Shukri in S, MacDiarmid Rates MJ, Retention Drake Urinary Acute 17. C. Mamoulakis F, Desgrandchamps MJ, Speakman M, Oelke 16. KoH,LeK,N ,e l eut farnoie,dul-ln,prle-ru,paeo and placebo- parallel-group, double-blind, randomized, a of Results al. for et symptom Y, bothersome Na most KS, the Lee relieving HC, of Kuo Importance 15. YS. Song WJ, Yang hypertrophy. SW, prostatic Doo benign SW, of Lee treatment 14. the Safety for and Tamsulosin Efficacy mirabegron M. Urodynamic of Lee H. Kakizaki efficacy 13. S, The Matsumoto K, al. Hashizume M, et Kita K, H, Ohba Iuchi A, N, Wada Asai 12. M, Yuzuriha K, overactive on Kakoki mirabegron Y, of Miyata safety and T, efficacy Matsuo The Y. 11. Gao Z, Chen L, Liu L, Liang J, Lin Shunye, Su 10. Kpa A eshr ,MVr T ta.Ecc n aeyo iaernvru lcb Add- Placebo versus Mirabegron of Safety and Efficacy al. et KT, McVary S, Herschorn SA, Therapy Add-on Kaplan Mirabegron 9. al. et B, Sumarsono D, Katou controlled JJ, Jong randomized O, Yamamoto A KS, Lee Y. H, Tanaka Kakizaki A, 8. Iwasawa T, symptoms Tsukamoto tract F, Fukuta urinary lower N, male Masumori muscle. for K, detrusor human guidelines Ichihara in Clinical 7. Beta3-adrenoceptors al. O. reasons Yamaguchi et Patient-reported 6. A, al. Kawauchi et M, M, Gotoh Hussein Y, J, Alvir Homma Z, 5. Jumadilova ES, Rovner MB, Nichol JS, Benner 4. ae rtrlsot uceb ulmcaiminvolving mechanism dual a by study. muscle controlled smooth randomized urethral ASSIST, laxes symptoms tract urinary lower randomized, for 78:126-133. men: treated Urol2011; in men symptoms 1002-1010. in 83: tract symptoms 2008; urinary Proc. lower Clin of Mayo study. treatment placebo-controlled for 2825-2830. double-blind, 182: tamsulosin 2009; with J.Urol combination frequency. and JAMA2006; urgency residual trial. with controlled men treated randomized alpha-blocker a bladder: overactive and 34:34-8. symptoms 2018; 296:2319-2328. Urol tract J urinary Ind lower men. in obstruction neck 104:1-4. bladder Urol2017; primary Risk. of Retention treatment Urinary or Volume in Residual Postvoid Participating on Symptoms Impact Tract Little Has Urinary Bladder Lower 86(4):654-665. Urol2015; With Review. Men Literature Adult A in Trials: and Pharmacotherapy Population Male General iebadri Asia. in bladder a tive mirabegron, of study multicenter active-controlled, symptoms. tract urinary lower with patients male 687. in life of quality improving Blad- (2):188-199. Overactive with Patients Male Japanese for Tamsulosin with der. Treatment Add-on 2016;16(1):1–7. Mirabegron Urol. of BMC men. elderly of analysis with treatment Prospective after symptoms systematic monotherapy: tract urinary A lower for therapy: therapy additional tamsulosin receiving men in hyperplasia meta-analysis. prostatic and review benign by induced Benign (PLUS). bladder Underlying Study for 4 Tamsulosin Phase Receiving Randomized, Symptoms A Bladder Overactive Hyperplasia: with Prostatic Men Symptoms: in Tract Therapy 2019;1–9. Urinary On Focus. Lower Urol with Eur Men (MATCH). in Study Bladder Placebo-controlled Overactive Randomized, of overactive Treatment A for the for mirabegron 2015;193(3):921–6. Tamsulosin with Urol. to combination J its obstruction. and prostatic monotherapy benign tamsulosin by induced of bladder efficacy the of study hyperplasia. prostatic benign and 2010;105(9):1276–82. Int. BJU medication. bladder overactive discontinuing for US oe rnr rc Symptoms Tract Urinary Lower LUTS: eruo Urodyn Neurourol eiie(Baltimore) Medicine n Urol J Int 05 34(7):685-692. 2015; 2016;8(3):171–6. 2017;24(10):716-729. . 9 00 99(4):e18802. 2020; . β -deoetraoit nptet ihoverac- with patients in agonist, 3-adrenoceptor Urology β Urol J arncpo ciainand activation -adrenoceptor 3 00 203(6):1163-1171. 2020; . 025( up 1):25-29. Suppl 2002;59(5 . α -deegcrcpo blocker receptor 1-adrenergic n Pharmacother Ann Urology 02 80(3):684- 2012; . 2000; . α - 1 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. oa cr mrvmn Tbea;IS-ssoeipoeet(al b n hnei h V (Table 1a TABLE PVR the in change (a-c): and 3 OABSS Table-1 groups. 3b) to Table patient (Table respect OABS. the improvement studywith induced present both score BPH the in IPSS-ss with on 3c) (Table3a); designs studies improvement study comparative similar score previous mirabegron total comparison groups. of a two depicting summary the Table 3 a in Table and same Depicting parameters patient the the 2: of of Table parameters features treatment demographic and post baseline the the protocol depicting depicting study 1b 1a current Table the (a-b): of 1 Table flow the depicting Figure 1: Fig TABLES & FIG FOR LEGENDS m/e)V (ml) VV (ml/sec) Q UROFLOWMETRY PVR(ml) QOL score sub 1.83 Storage IPSS score sub voiding IPSS IPSS 62.27 parameters 1.39 LUTS Baseline PSA(ng/ml) Sr. Creatinine(mg/dl) Sr. 3 Grade 2 Grade I GROUP Prostatomegaly Age(Years) PARAMETERS SnhI gra ,Gr .’aslsnadDrfncn ess’aslsnoohrp’fr’BPH for ’TamsulosinMonotherapy’ Versus Darifenacin’ and ’Tamsulosin G. Garg V, men Agarwal in I, symptoms overactivebladder Singh for 28. treatment a as Mirabegron al. et with YoonSJ, patients HW, male Kim in DG, Shin mirabegron of 27. effectiveness and Safety S. Uno H, Tabuchi D, Kato evaluate S, to Takahashi prospectivestudy randomized 26. comparative A tract- SK. urinary Singh lower AK, in Mandal UK, tamsulosin Mete vs DV, tadalafil Singh of 25. andsafety Efficacy S. Gupta Aravind, TK I, Singh 24. max ihAcmayn vrcieBadr.JCi igRes2015;9(6):PC08-11. Diag Clin J Bladder’. Overactive Accompanying 2018;1–10. with placebo- Urodynamics. double-blind, NeuroUrol multicenter,randomized, study. IV a phase from comparison results controlled,parallel safety study. and post-marketing study):Efficacy Japanese (MIRACLE A hyperplasia: prostatic benign 10.1111/luts.12335 without 2020;1–9.DOI: 2014;11(1):187-96. LUTS or Med. with Sex bladder J patients overactive BPH. in to alone tadalafil due or symptoms tamsulosin vs tract ClinPract. tadalafil urinary and J lower tamsulosin with of Int combination of study. safety and controlled efficacy randomised label (BPH)—open of result a 2020;00:e13530. as (LUTS) symptoms 2016;173:415–428. Pharmacol J Br blockade. adrenoceptor m/e)AFR (ml/sec) AS NF OABSS EORPI N AEIECHARACTERISTICS BASELINE AND DEMOGRAPHIC rd 1 Grade 236.90 3.89 58.38 12.68 18.45 7.95 7 (17.5%) (62.5%) 25 (20%) 8 (Mean ± ± ± ± ± ± ± ± .81.53 0.97 1.78 5.75 2.80 1.08 3.20 ± : 87 7.94 68.79 4.88 2.71 5.88 6.12 00 62.60 10.01 ± 120.12 S.D) ± ± ± 2.03 ± 0.52 5.09 4.03 10 2(0)2 5% 6 (15%) (55%) 22 (30%) 12 (Mean II GROUP 6.75 249.40 10.03 79.35 10.97 16.55 ± ± ± ± ± ± ± ± .90.290 0.210 3.90 2.08 0.79 0.23 ± 01 0.886 10.13 .34.72 8.03 119.39 5.03 3.02 5.88 6.19 ± 114.03 S.D) ± ± ± ± 1.35 3.80 0.92 4.81 0.586 Value P 0.056 0 0.850 . 6 .4 .5 0.292 0.954 0.443 667 < < 0.001 0.001 * * 0.171 0.392 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. Endpoint Baseline OABSS Total parameters Efficacy PARAMETERS GROUPS BETWEEN COMPARISON DATA TREATMENT POST 1b TABLE Significant. deviation. standard – S.D Volume, Voided VV- Rate, Flow Average AFR- rate, flow Q urine, residual void – post PVR life, of Quality – QOL Frequency, Nocturia NF- Score, Symptom Bladder Active Over OABSS- score, symptom prostate international – IPSS symptoms, tract urinary Lower – LUTS antigen, – prostate-specific PSA Serum, – Sr Endpoint Baseline frequency Day Endpoint Baseline Nocturia Endpoint Baseline Urgency Endpoint Baseline incontinence Urge Endpoint Baseline frequency Nocturia Endpoint Baseline IPSS Total max * maximum – - 2.33 7.95 Mean LOSIN TAMSU- + MIRABEGRON I GROUP 0.08 1 0.75 2.95 1.07 3.05 0.40 1.10 0.70 5.75 5.72 18.45 ± 0.64 ± ± ± ± ± ± ± ± ± ± ± ± ± 1.82 2.80 0.27 0.67 0.50 0.94 1.52 0.74 1.46 0.69 2.03 3.46 6.12 ± Significant. deviation. standard – S.D Volume, Voided VV- Rate, Flow Average AFR- rate, flow Q urine, residual void – post PVR life, of Quality – QOL Frequency, Nocturia NF- Score, Symptom Bladder Active Over OABSS- score, symptom prostate international – IPSS symptoms, tract urinary Lower – LUTS antigen, – prostate-specific PSA Serum, – Sr DMean SD max * hneFB Change LOSIN TAMSU- + MIRABEGRON I GROUP -5.68 -0.92 -2.20 -1.98 -0.70 -5.05 -12.72 maximum – - ± ± ± ± ± ± ± .56.75 1.85 .80.80 0.68 .52.73 0.65 .42.80 1.14 .40.42 1.04 .83.90 1.78 .916.55 4.19 11 Significant. deviation. standard – S.D Volume, Voided VV- Rate, Flow Average AFR- rate, flow Q urine, residual void – post PVR life, of Quality – QOL Frequency, Nocturia NF- Score, Symptom Bladder Active Over OABSS- score, symptom prostate international – IPSS symptoms, tract urinary Lower – LUTS antigen, – prostate-specific PSA Serum, – Sr Mean PLACEBO + LOSIN TAMSU- II GROUP 4.53 0.10 2.02 1.88 0.32 2.33 9.07 ± ± ± ± ± ± ± ± ± ± ± ± ± ± max 2.08 1.88 0.65 0.30 0.45 o.73 1.47 1.16 0.98 0.73 1.35 1.29 3.81 6.19 ± * maximum – - DMean SD hneFB change PLACEBO + LOSIN TAMSU- II GROUP -2.23 -0.70 -0.70 -0.92 -0.10 -1.57 -7.47 ± ± ± ± ± ± ± Significant. deviation. standard – S.D Volume, Voided VV- Rate, Flow Average AFR- rate, flow Q urine, residual void – post PVR life, of Quality – QOL Frequency, Nocturia NF- Score, Symptom Bladder Active Over OABSS- score, symptom prostate international – IPSS symptoms, tract urinary Lower – LUTS antigen, – prostate-specific PSA Serum, – Sr 1.59 .60.103 0.56 0.56 1.12 0.38 1.38 4.27 max * maximum – - P-value PLACEBO + LOSIN TAMSU- II GROUP < < < < < < 0.001 0.001 0.001 0.001 0.001 0.001 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. ciaae l()R 6Tmuoi 0.2mg Tamsulosin OF ARMS 76 NOS RC STUDY (7) al et Ichihara AUTHORS INDUCED BPH ON OABS STUDIES COMPARATIVE MIRABEGRON OF SUMMARY TABLE-2 Endpoint Baseline IPSS-V Endpoint Baseline IPSS-S Endpoint Baseline index QOL Endpoint Baseline PVR Endpoint Baseline VV Endpoint Q ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From max Baseline 2.48 5.85 3.27 12.68 1.82 4.88 51.17 58.38 366.30 236.90 11.98 7.94 ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From ± ± ± ± ± ± ± ± ± ± 2.84 5.09 1.26 0.55 0.52 4.03 ± ± 2.71 51.32 68.79 3.98 164.29 120.12 -3.40 -9.40 -7.20 129.40 4.04 -3.05 ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From ± ± ± ± ± .510.03 4.35 ± .25.88 3.12 .710.97 2.57 26 79.35 42.66 .55.03 0.55 4.4249.40 149.24 12 2.88 49.08 336.32 6.38 10.75 ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From 2.65 ± ± ± ± ± ± ± ± ± ± 4.81 2.90 2.16 0.92 0.95 ± ± 70.07 119.39 3.02 7.02 8.03 323.64 114.03 0.2mg Tamsulosin vs 50mg Mirabegron + STUDY THE 8weeks) (8 -3.00 -30.27 86.92 -4.60 0.72 ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From -2.38 ± ± ± ± ± 3,51 ± .80.752 3.08 2.35 1.00 288.99 96 0.136 89.62 CONCLUSIONS tamsulosin of postinitiation OABS residual with BPH in effective was mirabegron tamsulosin& with therapy Combination < < < ult flife of Quality QOL: score, sub storage IPSS IPSS-S: score, sub voiding IPSS score,IPSS-V: symptom prostate international IPSS- score, symptom bladder overactive OABSS- baseline, FB-From < 0.001 0.001 0.001 0.001 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. rsn td C10Tmuoi 0.4mg Tamsulosin 100 of Analysis of Analysis RC 26 Study Present 50 PA + Mirabegron (12) al et Wada PA 0.4mg Tamsulosin (11) al et 1317 Matsuo 676 MA 0.2mg Tamsulosin (10) al et Su Shunye RC 568 (9) al et Kaplan RC (8) al et Kakizaki 13 weeks) 0.4mg+Placebo Tamsulosin vs 50mg Mirabegron + weeks) tamsulosin. pre-existing to therapy on add (50mg) Mirabegron weeks) blocker. α to therapy on add (50mg) Mirabegron weeks) Tamsulosin vs tamsulosin weeks) (12 placebo + 0.4mg Tamsulosin Vs 50mg Mirabegron + weeks) 0.2mg+placebo Tamsulosin Vs 50mg Mirabegron + adrenergic 1 (12 (8-12 (8 (8 (12 nPVR/AUR. in increase an without OABS induced BPH for monotherapy Tamsulosin versus safe and efficacious significantly was therapy combination tamsulosin & Mirabegron OAB. with men in contractility bladder impairing without OABS improving in efficacious/safe was tamsulosin with treatment on add Mirabegron BPH. with men after OABS persistent in effective was therapy on add Mirabegron effects. side of occurrence low a with therapy tamsulosin receiving men in BPH by induced OABS for treatment safe and effective was Mirabegron placebo to comparison in OABS reducing in significant statistically was therapy on add Mirabegron tolerance good with placebo to efficacy superior demonstrated OABS & LUTS with men in 12wk for tamsulosin to therapy add-on Mirabegron α lcesin blockers 1 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. IMPROVEMENT SCORE IPSS-S TO RESPECT WITH STUDY PRESENT THE WITH DESIGNS STUDY SIMILAR PREVIOUS COMPARISION IMPROVEMENT SCORE IPSS-S TO RESPECT WITH STUDY PRESENT THE WITH DESIGNS STUDY SIMILAR PREVIOUS COMPARISION 3b TABLE deviation. Standard – S.D score, symptom bladder Overactive – OABSS difference Mean point(mean -2.78 End Mirabegron(50mg) Baseline(mean study Present GROUP STUDY -2.21 Mirabegron(50mg) (2017) Kakizaki(8) (2013) al(7) et Ichihara THE WITH DESIGNS STUDY IMPROVEMENT SCORE AUTHOR SIMILAR TOTAL OABSS TO PREVIOUS RESPECT WITH COMPARISION STUDY PRESENT 3a TABLE symptoms bladder OABS-Overactive residue, void PVR-Post retention, urinary AUR-Acute study, controlled Randomised RC- MA-Metanalysis, Analysis, PA-Prospective ± ± S.D) S.D) symptoms bladder OABS-Overactive residue, void PVR-Post retention, urinary AUR-Acute study, controlled Randomised RC- MA-Metanalysis, Analysis, PA-Prospective AL 3b TABLE 3b TABLE deviation. Standard – S.D score, symptom bladder Overactive – OABSS -5.62 7.95 Tamsulosin(0.2mg) + Tamsulosin(0.2mg) + baseline) from change (mean ± .02.33 2.80 ± 1.18 symptoms bladder OABS-Overactive residue, void PVR-Post retention, urinary AUR-Acute study, controlled Randomised RC- MA-Metanalysis, Analysis, PA-Prospective 14 deviation. Standard – S.D score, symptom bladder Overactive – OABSS 6.75 placebo + -2.13 (0.2mg) 0.012 Tamsulosin - P -0.87 Tamsulosin(0.2mg) line) base from change (mean GROUP(S) CONTROL -2.22 ± .84.53 2.08 symptoms bladder OABS-Overactive residue, void PVR-Post retention, urinary AUR-Acute study, controlled Randomised RC- MA-Metanalysis, Analysis, PA-Prospective ± 1.88 deviation. Standard – S.D score, symptom bladder Overactive – OABSS 0.001 - P P-VALUE P < 0.001 symptoms bladder OABS-Overactive residue, void PVR-Post retention, urinary AUR-Acute study, controlled Randomised RC- MA-Metanalysis, Analysis, PA-Prospective Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. HNEI PVR IN CHANGE TO RESPECT WITH STUDY PRESENT THE WITH STUDIES SIMILAR OF COMPARISION PVR IN CHANGE TO RESPECT WITH STUDY PRESENT THE WITH STUDIES SIMILAR OF COMPARISION PVR IN CHANGE TO RESPECT WITH STUDY PRESENT THE WITH STUDIES SIMILAR OF COMPARISION 3c TABLE deviation. Standard – S.D subscore, storage IPSS IPSS-S: difference Mean point(mean -2.29 End Mirabegron(50mg) Baseline(mean study Present GROUP STUDY -2.03 Mirabegron(50mg) (2017) Kakizaki(8) (2013) al(7) et Ichihara AUTHOR IMPROVEMENT SCORE IPSS-S TO RESPECT WITH STUDY PRESENT THE WITH DESIGNS STUDY SIMILAR PREVIOUS COMPARISION IMPROVEMENT SCORE IPSS-S TO RESPECT WITH STUDY PRESENT THE WITH DESIGNS STUDY SIMILAR PREVIOUS COMPARISION ± ± S.D) S.D) AL 3c TABLE 3c TABLE 3c TABLE deviation. Standard – S.D subscore, storage IPSS IPSS-S: -9.40 12.68 Tamsulosin(0.2mg) + Tamsulosin(0.2mg) + baseline) from change (mean 3b TABLE ± .13.27 2.71 ± 1.26 15 tnaddeviation. Standard – S.D subscore, storage IPSS IPSS-S: -7.48 10.97 placebo + -1.51 (0.2mg) 0.006 Tamsulosin - P -0.42 Tamsulosin(0.2mg) line) base from change (mean GROUP(S) CONTROL ± .26.38 3.02 ± 2.16 tnaddeviation. Standard – S.D subscore, storage IPSS IPSS-S: P P P-VALUE < < 0.001 0.001 Posted on Authorea 11 Dec 2020 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.160765069.91197704/v1 — This a preprint and has not been peer reviewed. Data may be preliminary. iue1: Figure Key: STUDY OF FLOW deviation. Standard – S.D urine, residual void Post PVR- difference Mean point(mean End Baseline(mean 2.72 Mirabegron(50mg) study Present (2017) 37.3 (8) Mirabegron(50mg) al GROUP et STUDY Kakizaki (2013) al(7) et Ichihara AUTHOR PVR IN CHANGE TO RESPECT WITH STUDY PRESENT THE WITH STUDIES SIMILAR OF COMPARISION T rnr rc neto,IS nentoa rsaesmtmsoe V otvi eiuluieOBS vrciebadrsmtmscore. symptom bladder Overactive urine,OABSS- residual void Post – PVR score, symptom prostate International – IPSS infection, tract urinary - UTI lwcatdpcigtepeetsuypooo process. protocol study present the depicting chart Flow ± ± S.D) S.D) tnaddeviation. Standard – S.D urine, residual void Post PVR- -7.20 58.38 Tamsulosin(0.2mg) + Tamsulosin(0.2mg) + baseline) from change (mean ± 87 51.17 68.79 ± 51.32 16 tnaddeviation. Standard – S.D urine, residual void Post PVR- 49.08 79.35 placebo + 0.020 – -0.97 P (0.2mg) Tamsulosin 3.9 Tamsulosin(0.2mg) baseline) the from change (mean GROUP(S) CONTROL ± ± 00 -30.27 70.07 119.39 tnaddeviation. Standard – S.D urine, residual void Post PVR- 0.059 - P P-VALUE 0.136 – P