Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Initial combined treatment with anticholinergics and α-blockers for men with lower urinary tract symptoms related to BPH and overactive bladder: a prospective, randomized, multi-center, double-blind, placebo-controlled study Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms: effects of prostate size. [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin]. Solifenacin as add-on therapy for overactive bladder symptoms in men treated for lower urinary tract symptoms--ASSIST, randomized controlled study. Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: Combined Treatment with Fesoterodine Fumarate Extended-Release and Tamsulosin - A Prospective Study Efficacy and safety of solifenacin plus tamsulosin OCAS in men with voiding and storage lower urinary tract symptoms: results from a phase 2, dose-finding study (SATURN). Solifenacin plus tamsulosin combination treatment in men with lower urinary tract symptoms and bladder outlet obstruction: a randomized controlled trial. Efficacy of combined amlodipine/terazosin therapy in male hypertensive patients with lower urinary tract symptoms: a randomized, double-blind clinical trial. Naftopidil and propiverine hydrochloride for treatment of male lower urinary tract symptoms suggestive of benign prostatic hyperplasia and concomitant overactive bladder: A prospective randomized controlled study Storage (irritative) and voiding (obstructive) symptoms as predictors of benign prostatic hyperplasia progression and related outcomes. Clinical effect of naftopidil on the quality of life of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a prospective study. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. 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. Long-term safety and efficacy of single-tablet combinations of solifenacin and tamsulosin oral controlled absorption system in men with storage and voiding lower urinary tract symptoms: results from the NEPTUNE Study and NEPTUNE II open-label extension. The effect of benign lower urinary tract symptoms on subsequent prostate cancer testing and diagnosis. Self-management for men with lower urinary tract symptoms Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. Randomized Controlled Trial to Assess the Efficacy of the Combination Therapy of Alfuzosin and Tadalafil in Patients with Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia. Effects of serum PSA on efficacy of tolterodine extended release with or without tamsulosin in men with LUTS, including OAB. Treatment of anterior vaginal wall prolapse with and without polypropylene mesh: a prospective, randomized and controlled trial - Part II. Update on AUA guideline on the management of benign prostatic hyperplasia.
OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews .  A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed We aim ed to evaluate the efficacy and safety of combination treatment using anticholinergics with α-blocker for initial treatment of both overactive bladder ( OAB ) and other lower urinary tract symptoms ( LUTS ) , secondary to BPH . A 12-week , r and omized , double-blind , placebo-controlled trial was conducted at four urology clinics in Korea , involving men , aged 50 years or older , with LUTS related to BPH and OAB . A total of 176 patients were r and omly assigned to receive doxazosin ( 4 mg ) plus placebo or doxazosin ( 4 mg ) plus tolterodine SR ( 4 mg ) , once a day for 12 weeks . Changes from baseline in total International Prostate Symptom Score ( IPSS ) , bladder diary variables , patient perception of bladder condition ( PPBC ) , uroflowmetry , postvoid residual volume and IPSS subscores ( voiding and storage ) were analyzed . Of the 176 enrolled patients , 91 had doxazosin gastrointestinal therapeutic system ( GITS ) and placebo , and 85 had combined medication with doxazosin GITS and tolterodine SR . Compared with the doxazosin plus placebo group , the doxazosin plus tolterodine group showed significant reductions in IPSS storage subscore and improvement in the quality of life item , urgency episodes , as well as in micturition frequency at weeks 4 and 12 . However , it failed to improve PPBC at week 4 as well as at week 12 . Earlier intervention with anticholinergics plus α-blocker was tolerated well , including the questions about urinary retention ( n=1 ) and dry mouth ( n=2 ) . Initial combination treatment of anticholinergics plus α-blocker showed positive results for men with LUTS related to BPH and OAB symptoms and did not increase the risk of urinary retention BACKGROUND Some men with lower urinary tract symptoms ( LUTS ) including overactive bladder ( OAB ) symptoms may benefit from antimuscarinic therapy , with or without an alpha-adrenergic antagonist . OBJECTIVES To evaluate the safety and efficacy of tolterodine extended release ( ER ) , tamsulosin , or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials , stratified by prostate size . DESIGN , SETTING , AND PARTICIPANTS Subjects with an International Prostate Symptom Score ( IPSS ) > or=12 ; frequency and urgency , with or without urgency urinary incontinence ; postvoid residual volume ( PVR ) < 200 mL ; and maximum urinary flow rate ( Q(max ) ) > 5 mL/s were r and omized to receive placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER+tamsulosin for 12 wk . Data were stratified by median baseline prostate volume ( < 29 mL vs > or=29 mL ) . MEASUREMENTS Endpoints included week 12 changes in bladder diary variables , IPSS scores , and safety variables . RESULTS AND LIMITATIONS Among men with larger prostates , tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) ; urgency ( p=0.006 ) ; and IPSS total ( p=0.001 ) , storage ( p<0.001 ) , and voiding scores ( p<0.013 ) . Tamsulosin significantly improved IPSS voiding scores ( p=0.030 ) . Among men with smaller prostates , tolterodine ER significantly improved frequency ( p=0.016 ) , UUI episodes ( p=0.036 ) , and IPSS storage scores ( p=0.005 ) . Tolterodine ER+tamsulosin significantly improved frequency ( p=0.001 ) and IPSS storage scores ( p=0.018 ) . Tamsulosin significantly improved nocturnal frequency ( p=0.038 ) and IPSS voiding ( p=0.036 ) and total scores ( p=0.044 ) . There were no clinical ly or statistically significant changes in Q(max ) or PVR ; incidence of acute urinary retention ( AUR ) was low in all groups ( < or=2 % ) . CONCLUSIONS Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER . Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size . Tolterodine ER , with or without tamsulosin , was well tolerated and not associated with increased incidence of AUR We compared the efficacy of naftopidil monotherapy with combination therapy using tamsulosin hydrochloride and solifenacin succinate in the treatment of lower urinary tract symptoms ( LUTS ) with overactive bladder ( OAB ) secondary to benign prostatic hyperplasia ( BPH ) . Thirty one patients were enrolled in a r and omized crossover study . Fourteen patients were initially prescribed naftopidil 75 mg ( N ) for 8 weeks , followed by tamsulosin 0.2 mg and solifenacin 5 mg ( TS ) for 8 weeks ( group N ) ; another 17 were initially prescribed TS , followed by N ( group TS ) . The efficacy variables were the changes in international prostate symptom score ( I-PSS ) , quality of life ( QOL ) score , overative bladder symptom score ( OABSS ) , and post-void residual ( PVR ) urine volume . After the study , a question naire survey was carried out about the choice of treatment . After treatment with each agent , total I-PSS , storage symptom score , QOL score and OABSS except for the daytime frequency were significantly improved from baseline . PVR was significantly increased after TS treatment . There were no significant differences between the two treatments except for PVR . As a result of the question naire survey , 13 patients chose N and 17 chose TS . In conclusion , N monotherapy can be expected to have an equal effect in the treatment of LUTS with OAB secondary to BPH in comparison with TS combination therapy OBJECTIVES To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms ( LUTS ) men with residual overactive bladder ( OAB ) symptoms despite tamsulosin monotherapy . METHODS In this r and omized , multicenter , double-blind study , male LUTS patients aged≥50 years with urgency episodes/24 hours≥2 and micturitions/24 hours≥8 were r and omized to 3 groups : 12-weeks tamsulosin plus placebo ( TAM+PBO ) , tamsulosin plus solifenacin 2.5 mg ( TAM+SOL ) , and tamsulosin plus solifenacin 5 mg ( TAM+SOL ) . Changes from baseline to end of treatment in the number of urgency episodes/24 hours ( primary endpoint ) , micturitions , nocturia , urgency incontinence episodes , International Prostate Symptom Scores ( IPSS ) , and Overactive Bladder Symptom Score ( OABSS ) were compared between the TAM+SOL groups and TAM+PBO . Safety was assessed on adverse events , postvoid residual volume , and maximal urinary flow rate ( Qmax . ) . RESULTS Six-hundred thirty-eight men were r and omized . Urgency was reduced by 2.2 and 2.4 episodes in the TAM+SOL 2.5 and 5 mg groups , respectively . The TAM+SOL 5 mg group showed significant improvement compared with TAM+PBO ( -2.4 vs -1.9 , P=.049 ) . The number of micturitions in both TAM+SOL groups were significantly reduced compared with TAM+PBO ( both P<.001 ) . IPSS storage symptom score and OABSS significantly improved in both TAM+SOL groups compared with TAM+PBO . Changes in IPSS voiding symptom score and Qmax . were similar in all groups . Four patients ( 1.9 % ) in the TAM+SOL 5 mg group had urinary retention , but all recovered after catheterization . CONCLUSIONS In male LUTS patients with residual OAB symptoms  despite tamsulosin monotherapy , TAM+SOL showed efficacy on urgency , which represents OAB symptoms and was well tolerated Purpose To evaluate how much the improvement of lower urinary tract symptoms ( LUTS ) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function . Material s and Methods A total of 187 patients were enrolled in this study . Patients were r and omly assigned to receive either tamsulosin 0.2 mg ( group A ) or tamsulosin 0.2 mg and solifenacin 5 mg ( group B ) . At 4 weeks and 12 weeks , the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-5 ( IIEF5 ) , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Symptom Score ( OABSS ) question naire , uroflowmetry , and bladder scan . Results Both groups A and B showed statistically significant improvements in IPSS , OABSS , and quality of life ( QoL ) . Group A showed improved maximum flow rate , mean flow rate , and residual urine volume by time . Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time . The IIEF5 score was not improved in either group . In group A , the IIEF5 score dropped from 13.66±4.97 to 11.93±6.14 after 12 weeks ( p=0.072 ) . Group B showed a decline in the IIEF5 score from 13.19±5.91 to 12.45±6.38 ( p=0.299 ) . Although group B showed a relatively smaller decrease in the IIEF5 score , the difference between the two groups was not significant ( p=0.696 ) . Conclusions Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL. The improvement in storage symptoms did not affect erectile function Objective : To evaluate the efficacy and safety of fesoterodine extended-release ( ER ) plus tamsulosin in men with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . Patients and Methods : Men aged ≥50 years , with LUTS , prostate volume ≤60 ml and International Prostate Symptom Score ( IPSS ) ≥13 were enrolled in this study . 173 consecutive patients were treated initially with tamsulosin ( 0.4 mg ) for 1 week . At the second visit , 47 patients out of the sample of 173 who were still experiencing inconvenient LUTS were r and omized into two groups . The first group received a therapy with tamsulosin and fesoterodine combination ( group 1 , n = 24 ) while the second continued the therapy with the single administration of tamsulosin ( group 2 , n = 23 ) for an additional 4-week period . Results : There was no statistically significant difference in age , prostate volume , Qmax , and postvoid residual urine between the two groups . A statistical significance appeared in the combination group regarding the storage and the total IPSS values among the second and third visits ( 10.5 ± 1.4 to 8.5 ± 1.3 and 16.1 ± 1.8 to 13.7 ± 1.5 respectively ) . Conclusion : Regarding bothersome LUTS and storage symptoms  , fesoterodine ER and tamsulosin combination was significantly more effective than the single administration of tamsulosin BACKGROUND Storage symptoms are often undertreated in men with lower urinary tract symptoms ( LUTS ) . OBJECTIVE To evaluate the combination of an antimuscarinic ( solifenacin ) with an α-blocker ( tamsulosin ) versus tamsulosin alone in the treatment of men with LUTS . DESIGN , SETTING , AND PARTICIPANTS A double-blind , 12-wk , phase 2 study in 937 men with LUTS ( ≥ 3 mo , total International Prostate Symptom Score [ IPSS ] ≥ 13 , and maximum urinary flow rate 4.0 - 15.0 ml/s ) . INTERVENTION Eight treatment groups : tamsulosin oral controlled absorption system ( OCAS ) 0.4 mg ; solifenacin 3 , 6 , or 9 mg ; solifenacin 3 , 6 or 9 mg plus tamsulosin OCAS 0.4 mg ; or placebo . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary efficacy end point was change from baseline in total IPSS . Secondary end points included micturition diary and quality -of-life ( QoL ) parameters . Post hoc subgroup analyses were performed by severity of baseline storage symptoms , with statistical comparisons presented only for tamsulosin OCAS alone versus combination therapy , due to the small sample size of the solifenacin monotherapy and placebo subgroups . RESULTS AND LIMITATIONS Combination therapy was associated with significant improvements in micturition frequency and voided volume  versus tamsulosin OCAS alone in the total study population ; improvements in total IPSS were not significant . Statistically significant improvements in urgency episodes , micturition frequency , total urgency score , voided volume , IPSS storage subscore , IPSS-QoL index , and Patient Perception of Bladder Condition were observed in a sub population of men with two or more urgency episodes per 24h ( Patient Perception of Intensity of Urgency Scale grade 3 or 4 ) and eight or more micturitions per 24h at baseline ( storage symptoms subgroup ) with combination therapy versus tamsulosin OCAS alone ( p ≤ 0.05 for the dose-response slope , all variables ) . Combination therapy was well tolerated , and adverse events were consistent with the safety profiles of both compounds . CONCLUSIONS Solifenacin plus tamsulosin OCAS did not significantly improve IPSS in the total study population but offered significant efficacy and QoL benefits over tamsulosin OCAS monotherapy in men with both voiding and storage symptoms at baseline . Combination therapy was well tolerated . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00510406 BACKGROUND Alpha blockers are prescribed to manage lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) .  Antimuscarinics are prescribed to treat overactive bladder ( OAB ) . OBJECTIVE To investigate the safety of a combination of solifenacin ( SOLI ) and tamsulosin oral controlled absorption system ( TOCAS ) in men with LUTS and bladder outlet obstruction ( BOO ) . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , parallel-group , placebo-controlled study in men aged > 45 yr with LUTS and BOO for ≥3 mo , total International Prostate Symptom Score ( IPSS ) ≥8 , BOO index ≥20 , maximum urinary flow rate ( Q(max ) ) ≤12 ml/s , and voided volume ≥120 ml . INTERVENTIONS Once-daily coadministration of TOCAS 0.4 mg plus SOLI 6 mg , TOCAS 0.4 mg plus SOLI 9 mg , or placebo for 12 wk . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Primary ( safety ) measurements : Q(max ) and detrusor pressure at Q(max ) ( P(det)Q(max ) ) . Other safety assessment s included postvoid residual ( PVR ) volume . Secondary end points included bladder contractile index ( BCI ) score and percent bladder voiding efficiency ( BVE ) . An analysis of covariance model compared each TOCAS plus SOLI combination with placebo . RESULTS AND LIMITATIONS Both active treatment groups were noninferior to placebo at end of treatment ( EOT ) for P(det)Q(max ) and Q(max ) . Mean change from baseline PVR was significantly higher at all time points for TOCAS 0.4 mg plus SOLI 6 mg , and at weeks 2 , 12 , and EOT for TOCAS 0.4 mg plus SOLI 9 mg versus placebo . Both treatment groups were similar to  placebo for BCI and BVE . Urinary retention was seen in only one patient receiving TOCAS 0.4 mg plus SOLI 6 mg . Limitations of the study were that prostate size and prostate-specific antigen level were not measured . CONCLUSIONS TOCAS 0.4 mg plus SOLI 6 mg or 9 mg was noninferior to placebo at EOT for P(det)Q(max ) and Q(max ) in men with LUTS and BOO , and there was no clinical or statistical evidence of increased risk of urinary retention OBJECTIVES To investigate the therapeutic efficacy and safety of Amlodipine alone or in combination with terazosin for the presence of lower urinary tract symptoms ( LUTS ) and hypertension . LUTS and hypertension often coexist in elderly men . METHODS A total of 355 patients with Stage 1 or 2 hypertension and LUTS ( as defined by an International Prostate Symptom Score of > or = 10 ) were r and omly assigned to receive 2 mg of terazosin ( n = 117 ) , 5 mg of Amlodipine ( n = 119 ) , or 5 mg of Amlodipine plus 2 mg of terazosin ( n = 119 ) once daily for a total of 28 days . The primary outcomes were a reduction in the total and subscores of the International Prostate Symptom Score and blood pressure . Analyses were performed by intention to treat . This trial is registered with Clinical Trials.gov ( No. NCT00693199 ) . RESULTS At day 28 of the trial , the Amlodipine plus terazosin group demonstrated comparable efficacy in lowering the total International Prostate Symptom Score and significant improvement in the presence of overactive bladder compared with the terazosin group ( P < .05 ) and significant improvement in quality of life compared with the Amlodipine group ( P < .05 ) . The Amlodipine plus terazosin group also achieved the greatest blood pressure control compared with either the terazosin group ( P < .01 ) or Amlodipine group ( P < .05 ) . All 3 treatment regimens were well tolerated by the study patients . CONCLUSIONS The results of this 4-week , double-blind , r and omized trial have demonstrated that in Chinese male hypertensive patients with LUTS , low-dose Amlodipine plus terazosin therapy appears to be a safe and effective combination therapy to control both conditions , especially for those with predominant overactive bladder symptoms Objective . To assess the efficacy and safety of propiverine hydrochloride ( antimuscarinic ) , naftopidil ( α1-adrenoceptor antagonist ) or both in patients with male lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia and concomitant overactive bladder ( OAB ) . Material and methods . Men aged at least 50 years who had a total International Prostate Symptom Score ( IPSS ) of 8 or higher and bladder dairy documenting micturition frequency ( more than eight micturitions/24 h ) and urgency ( more than one episode/24 h ) , with or without urgency urinary incontinence were r and omized into three groups : group N , naftopidil ( 50 mg once daily ) only ; group P , propiverine hydrochloride ( 20 mg once daily ) ; and group NP , naftopidil ( 50 mg once daily ) plus propiverine hydrochloride ( 20 mg once daily ) for a 4-week treatment regimen . Results . A total of 66 men , including 20 in group N , 23 in group P and 23 in group NP , were treated and 58 ( 87.9 % ) completed the 4 weeks of treatment . IPSS improved significantly in groups N and NP . Urinary frequency improved significantly in groups P and NP . Postvoid residual urine volume increased significantly in groups P and NP . Significant improvements in urgency episodes were noted in each group . One patient in group P required catheterization owing to acute urinary retention and another stopped medication because of difficulty in voiding . Conclusion . These results suggest that each treatment showed effectiveness for male LUTS with OAB . However , there are some possibilities of adverse effects with propiverine hydrochloride monotherapy OBJECTIVES To assess the utility of voiding and filling symptom subscores in predicting features of benign prostatic hyperplasia ( BPH ) progression , including acute urinary retention ( AUR ) and prostate surgery . METHODS The Proscar Long-term Efficacy and Safety Study ( PLESS ) was a 4-year study design ed to evaluate the effects of finasteride versus placebo in men with lower urinary tract symptoms ( LUTS ) , clinical evidence of BPH , and no evidence of prostate cancer . A self-administered question naire was employed to quantify LUTS at baseline . Receiver operating characteristics ( ROC ) curves were used to assess baseline characteristics from patients treated with placebo as predictors of outcomes . The characteristics assessed included the overall symptom score ( Quasi-AUA SI ) , separate voiding and filling subscores , prostate volume ( PV ) and serum prostate-specific antigen ( PSA ) levels . RESULTS PV and PSA were superior to the symptom scores at predicting episodes of spontaneous AUR and all types of AUR . The Quasi-AUA SI and the filling and voiding subscores were effective at predicting progression to surgery ; however , PSA was more effective at predicting this outcome . To better evaluate symptoms as predictors of surgery , patients who experienced a preceding episode of AUR were excluded from the surgery analysis . In the absence of preceding AUR , the best predictors of future surgery were the Quasi-AUA SI and the filling subscore . CONCLUSIONS Among men with LUTS , clinical BPH and no history of AUR , the overall symptom score and storage subscore are useful parameters to aid clinicians in identifying patients at risk for future prostate surgery . PV and PSA were the best predictors of AUR , while PSA was the best predictor of prostate surgery ( for all indications ) OBJECTIVES To investigate the benefit of alpha1-adrenoceptor antagonist naftopidil on the quality of life ( QOL ) of patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( BPH/LUTS ) . METHODS A total of 99 men with BPH/LUTS were prospect ively recruited . The Short Form-8 ( SF-8 ) was used for generic QOL assessment and each parameter was compared with the norm in these patients . Longitudinal changes were evaluated using the SF-8 and the International Prostatic Symptoms Score ( I-PSS ) at baseline , 4 and 8 weeks after naftopidil administration . The relationship between SF-8 and I-PSS was analyzed . RESULTS Five of eight components in the SF-8 were significantly lower than the Japanese national norm at baseline . SF-8 score was improved by naftopidil at 4 and 8 weeks in general health ( GH ) and physical component summary ( PCS ) in the patients in their 70s . Mental health ( MH ) and mental component summary ( MCS ) were improved at 8 weeks in patients in their 60s . When analyzing the whole cohort , SF-8 GH , role emotional ( RE ) and MH had improved at 8 weeks , which was similar to the norm , and bodily pain ( BP ) results were better . Compared with the baseline , total I-PSS , storage/voiding symptoms and QOL index scores improved significantly under naftopidil . Each component of I-PSS ( except for hesitancy ) correlated with SF-8 sub-scales ( except for BP ) to some extent . CONCLUSIONS BPH/LUTS impairs generic QOL , which is improved by naftopidil treatment . SF-8 can be a useful instrument to assess the efficacy of BPH/LUTS treatment because its simplicity to complete and analyze , and its meaningful relationship to I-PSS OBJECTIVE To compare the efficacy and safety of a combination therapy , doxazosin plus tenoxicam , and doxazosin alone for lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) , as various combination therapies increase the efficacy of medical therapy . Alpha blocker agents have been widely used for the treatment of LUTS secondary to BPH . METHOD Fifty-seven patients complaining of LUTS secondary to BPH were enrolled in this clinical trial . Patients were r and omly assigned to receive doxazosin 4 mg or doxazosin 4 mg plus tenoxicam 20 mg treatment . Patients were evaluated for BPH according to the European Association of Urology and American Urological Association clinical guidelines . In addition , patients were assessed with Overactive Bladder Symptom Score ( OABSS ) and International Index of Erectile Function ( IIEF ) . Patients were reevaluated after a 6-week treatment course . The International Prostatic Symptom Score ( IPSS ) , IPSS- Quality of Life ( IPSS-QoL ) , maximal urinary flow rates ( Q(max ) ) , and average urinary flow rates ( AFR ) were determined at baseline and again at 6 weeks as efficacy parameters . RESULTS The total IPSS , IPSS-QoL , and OABSS decreased significantly in both tenoxicam plus doxazosin group and doxazosin alone group compared with baseline ( P < .01 ) . Also , Q(max ) and AFR significantly improved in both groups ( P < .01 ) . The improvements in IPSS , IPSS-QoL , and OABSS were significantly better in patients treated with combination therapy ( P < .05 ) . CONCLUSIONS COX-2 inhibitors in combination with an alpha blocker may increase the effectiveness of the therapy for LUTS secondary to BPH without significant effects on side effect profile INTRODUCTION Safety and efficacy of tamsulosin and vardenafil are well established : however , there is no report regarding combined therapy with these drugs for  lower urinary tract symptoms ( LUTSs ) secondary to benign prostatic hyperplasia ( BPH ) . AIM To compare the safety and efficacy of tamsulosin 0.4 mg/day vs. tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in patients with LUTS/BPH in a r and omized trial with 12-week follow-up . METHODS We conducted a r and omized , double-blind , placebo-controlled study on 60 men with persistent storage LUTS after 2-week run-in with tamsulosin .  MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS-bother , International Index of Erectile Function , Version 5 ( IIEF-5 ) and Over Active Bladder question naire ( OAB-q ) scores , uroflowmetry data ( Qmax , Qave ) , and postvoiding residual urine were recorded after run-in ( baseline ) , and 2 and 12 weeks after treatment . Differences between vardenafil and placebo at different times were calculated with unpaired sample s t-test . Between-group differences in change from baseline to 2 and 12 weeks were evaluated with analysis of variance . RESULTS We found a between-group significant difference from baseline to 12 weeks in the following : ( i ) Qmax ( placebo : + 0.07 , vardenafil : + 2.56 , P = 0.034 ) ; ( ii ) Qave  ( placebo : -0.15 , vardenafil : + 1.02 , P = 0.031 ) ; ( iii ) irritative-IPSS subscores ( placebo : -1.67 , vardenafil : -3.11 , P = 0.039 ) ; and ( iv ) IIEF ( placebo : + 0.06 , vardenafil : + 2.61 , P = 0.030 ) . No patient reported any serious ( grade ≥ 2 ) adverse event ( AE ) . There were no differences in the incidence of common , treatment-related AEs between men undergoing combined therapy or tamsulosin alone . CONCLUSIONS The combination of tamsulosin and vardenafil for 12 weeks was well tolerated and more effective to improve both LUTS and erectile function , as compared with tamsulosin alone . Further studies are needed to assess the role of combined therapy of phosphodiesterase type 5 inhibitors and alpha blockers in treating LUTS/BPH BACKGROUND Short-term trials have demonstrated the efficacy and safety of combination therapy using antimuscarinics and α-blockers in men with lower urinary tract symptoms ( LUTS ) . The Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS ( oral controlled absorption system ) in Males with Lower Urinary Tract Symptoms ( NEPTUNE ) II is the first long-term study using solifenacin ( Soli ) and the oral controlled absorption system formulation of tamsulosin ( TOCAS ) . OBJECTIVE To evaluate long-term ( up to 52 wk ) safety and efficacy of flexible dosing of two fixed-dose combinations ( FDC ) of Soli plus TOCAS in men with moderate to severe storage symptoms and voiding symptoms . DESIGN , SETTING , AND PARTICIPANTS Patients with both storage and voiding LUTS , maximum urinary flow rate of 4.0 - 12.0 ml/s , prostate size < 75 ml , and postvoid residuals ≤ 150 ml , who completed the 12-wk , double-blind NEPTUNE study could continue in the 40-wk , open-label NEPTUNE II study . INTERVENTION FDC of Soli 6 mg plus TOCAS 0.4 mg , or Soli 9 mg plus TOCAS 0.4 mg ; patients could switch between doses in NEPTUNE II . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Safety and efficacy data from NEPTUNE and NEPTUNE II were combined to cover a 52-wk period . Primary efficacy end points were total International Prostate Symptom Score ( IPSS ) and total urgency and frequency score ( TUFS ) ; secondary end points included IPSS storage and voiding subscores , micturition diary variables , and quality of life parameters . RESULTS In all , 1066 men completed NEPTUNE and received one dose or more of study medication in NEPTUNE II . Treatment-emergent adverse events were reported in 499 ( 46.8 % ) patients who participated in NEPTUNE II ; most were mild or moderate . Urinary retention occurred in 13 of 1208 ( 1.1 % ) patients receiving one or more FDCs in NEPTUNE and /or NEPTUNE II ; 8 ( 0.7 % ) required catheterisation ( acute urinary retention [ AUR ] ) . Reductions in total IPSS and TUFS during NEPTUNE were maintained for up to 52 wk of FDC treatment , with mean reductions of 9.0 ( st and ard deviation [ SD ] : 5.7 ) and 10.1 ( SD : 9.2 ) , respectively , from baseline to end of treatment . Clinical ly relevant improvements were also observed for secondary efficacy end points . CONCLUSIONS Long-term treatment with FDC Soli plus TOCAS was well tolerated and efficacious in men with storage and voiding LUTS , with a low incidence of AUR . PATIENT SUMMARY Treatment with solifenacin plus tamsulosin in a fixed-dose combination tablet was well tolerated by men with lower urinary tract symptoms . Improvements in symptoms were achieved after 4 wk of treatment , with further improvements at week 16 maintained for up to 52 wk throughout the study BACKGROUND Lower urinary tract symptoms ( LUTS ) are common and have been associated with the subsequent diagnosis of prostate cancer ( PCa ) in population cohorts . OBJECTIVE To determine whether the association between LUTS and PCa is due to the intensity of PCa testing after LUTS diagnosis . DESIGN , SETTING , AND PARTICIPANTS We prospect ively followed a representative , population -based cohort of 1922 men , aged 40 - 79 yr , from 1990 until 2010 with interviews , question naires , and abstract ing of medical records for prostate outcomes . Men were excluded if they had a previous prostate biopsy or PCa diagnosis .  Self-reported LUTS was defined as an American Urological Association symptom index score > 7 ( n=621 ) . Men treated for LUTS ( n=168 ) were identified from review of medical records and /or self report . Median follow-up was 11.8 yr ( interquartile range : 10.7 - 12.3 ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Associations between self-reported LUTS , or treatment for LUTS , and risk of subsequent prostate biopsy and PCa were estimated using Cox proportional hazard models . RESULTS AND LIMITATIONS Fifty-five percent of eligible men enrolled in the study . Men treated for LUTS were more likely to undergo a prostate biopsy ( hazard ratio [ HR ] : 2.4 ; 95 % confidence interval [ CI ] , 1.7 - 3.3 ) . Men younger than 65 yr who were treated for LUTS were more likely to be diagnosed with PCa ( HR : 2.3 , 95 % CI , 1.5 - 3.5 ) , while men aged > 65 yr were not ( HR : 0.89 , 95 % CI , 0.35 - 1.9 ) . Men with self-reported LUTS were not more likely to be biopsied or diagnosed with PCa . Neither definition of LUTS was associated with subsequent intermediate- to high-risk cancer . The study is limited by lack of histologic or prostate-specific antigen level data for the cohort . CONCLUSIONS These results indicate that a possible cause of the association between LUTS and PCa is increased diagnostic intensity among men whose LUTS come to the attention of physicians . Increased symptoms themselves were not associated with intensity of testing or diagnosis Treatment for men with lower urinary tract symptoms ( LUTS ) has developed into a “ cascade ” that escalates from watchful waiting through medical treatment to surgery . Self-management can help men to adopt lifestyle and behavioral modifications that will avoid or delay an escalation in treatment and reduce symptoms . Although many of these interventions are advised to men with LUTS , it is usually in a nonst and ardized and un systematic way . Recent work in this area has defined a self-management program for men with uncomplicated LUTS using formal methods and assessed its effectiveness in a r and omized controlled trial . Self-management significantly reduced the frequency of escalation through the treatment cascade and reduced urinary symptoms ( as effective as medication ) , suggesting that self-management could be considered as first-line treatment for men with LUTS INTRODUCTION Erectile dysfunction ( ED ) and lower urinary tract symptoms suggestive of benign prostatic hyperplasia ( LUTS/BPH ) are common in aging males and frequently occur together . Tadalafil has demonstrated efficacy in treating both conditions . AIM The study aims to evaluate the efficacy and safety of tadalafil 5 mg once daily vs. placebo over 12 weeks in treating both LUTS/BPH and ED in sexually active men . We also assessed relationships of baseline disease severity and prostate specific antigen ( PSA ) to outcomes . METHODS Data were pooled from four multinational , r and omized studies of men ≥45 years with LUTS/BPH , with analyses restricted to sexually active men with ED . R and omization ( baseline ) followed a 4-week placebo run-in ; changes from baseline were assessed vs. placebo using analysis of covariance . MAIN OUTCOME MEASURES International Prostate Symptom Score ( IPSS ) , IPSS subscores , Quality -of-Life Index ( IPSS-QoL ) , BPH Impact Index ( BII ) , and International Index of Erectile Function-Erectile Function ( IIEF-EF ) Domain score were used in this study . RESULTS Tadalafil ( N = 505 ) significantly improved total IPSS vs. placebo ( N = 521 ) ; mean changes from baseline were -6.0 and -3.6 , respectively ( P < 0.001 ) . Improvements in IIEF-EF Domain score  ( tadalafil , 6.4 ; placebo , 1.4 ) were also significant vs. placebo , as were the IPSS storage and voiding subscores , IPSS-QoL , and BII ( all P < 0.001 ) . No significant impact of baseline ED severity or PSA category on IPSS response was observed ( interaction P values , 0.463 and 0.149 , respectively ) . Similarly , improvement in IIEF-EF Domain score was not significantly impacted by baseline LUTS/BPH severity or PSA category ( interaction P values , 0.926 and 0.230 , respectively ) . Improvements in IPSS and IIEF-EF Domain score during treatment were weakly correlated ( r = -0.229 ) . Treatment-emergent adverse events were consistent with previous reports . CONCLUSIONS Tadalafil was efficacious and well tolerated in treating ED and LUTS/BPH in sexually active men with both conditions . Improvements in both conditions were significant regardless of baseline severity . Improvements in the total IPSS and the IIEF-EF Domain score were weakly correlated OBJECTIVE The purpose of our study was to evaluate the effect of alfuzosin and tadalafil as combination therapy compared with each monotherapy , in patients with lower urinary tract symptoms ( LUTS ) due to benign prostatic hyperplasia ( BPH ) . METHODS Men over the age of 50 years with LUTS secondary to BPH and an International Prostate Symptom Score ( IPSS ) 8 or higher , were r and omized to receive 10 mg alfuzosin ( n = 25 ) , 10 mg tadalafil ( n = 25 ) or the combination of both the drugs ( n = 25 ) once daily for 3 months . Symptoms were assessed at baseline , 6 weeks and 3 months . The primary endpoint was the change in IPSS from the baseline . Secondary endpoints were changes in IPSS storage and voiding subscores , peak urinary flow rate , residual urine volume , IPSS quality of life score and erectile domain score . RESULTS There were significant improvements in all IPSS scores , peak urinary flow rate and IPSS quality of life score from baseline at both 6 weeks and 3 months in all the three groups ( P < 0.003 ) . Combination therapy was better than monotherapy in improving IPSS scores and reducing post-void residual urine volume ( P < 0.005 ) . Combination therapy was similar to alfuzosin regarding improvement in maximum urine flow rate ( P = 0.22 ) , similar to tadalafil in improvement on erectile function ( P = 0.22 ) and better than each monotherapy in improving the IPSS quality of life ( P ≤ 0.015 ) . CONCLUSION Alfuzosin and tadalafil combination therapy provides greater symptomatic improvement as compared to either monotherapy in men with LUTS due to BPH OBJECTIVES To evaluate the efficacy of tolterodine extended release ( ER ) , tamsulosin , and tolterodine ER plus tamsulosin in men with symptoms of overactive bladder and benign prostatic hyperplasia stratified by prostate-specific antigen ( PSA ) level . METHODS We performed a post hoc analysis of data from men > or=40 years old with frequency and urgency ( with or without urge urinary incontinence ) , postvoid residual urine volume < 200 mL , maximal urinary flow rate > 5 mL/s , International Prostate Symptom Score ( IPSS ) of > or=12 , and quality -of-life score of > or=3 . They had been r and omized to placebo , tolterodine ER ( 4 mg ) , tamsulosin ( 0.4 mg ) , or tolterodine ER plus tamsulosin for 12 weeks . The men were stratified by the median baseline PSA level ( > or=1.3 vs < 1.3 ng/mL ) . Assessment s included changes in bladder diary variables and IPSSs . The men rated the urgency level of each micturition , and the frequency-urgency sum was defined as the total of these ratings . RESULTS The PSA level correlated significantly with prostate size . Men with a PSA level of > or=1.3 ng/mL receiving tolterodine ER plus tamsulosin showed significantly greater improvements in 24-hour frequency , daytime frequency , the frequency-urgency sum , total IPSS , and IPSS storage score compared with those receiving placebo . Tamsulosin significantly improved the IPSS voiding scores , but tolterodine ER was ineffective . In men with a PSA level < 1.3 ng/mL , tolterodine ER alone and tolterodine ER plus tamsulosin significantly improved the 24-hour frequency , daytime frequency , frequency-urgency sum , and IPSS storage scores compared with those receiving placebo ; tamsulosin alone was ineffective . No significant changes were found in the postvoid residual urine volume or maximal urinary flow rate in any group , and the acute urinary retention rates were low . CONCLUSIONS The results of our study have shown that tolterodine ER was efficacious in men with lower urinary tract symptoms , including overactive bladder , who had lower PSA levels ( < 1.3 ng/mL ) OBJECTIVE To compare the effects of two surgical procedures for the correction of anterior vaginal wall prolapse ( AVWP ) on the lower urinary tract symptoms ( LUTS ) using symptom question naires and quality of life ( QoL ) . MATERIAL S AND METHODS One hundred women with Pelvic Organ Prolapse Quantification stage ( POP-Q ) ≥ 2 were r and omly distributed in two preoperatory groups . The first group ( mesh ) ( n = 45 ) received a polypropylene mesh ( PM ) implant and the control group ( n = 55 ) was su bmi tted to anterior colporraphy with or without synthetic sling . Postoperatory follow-up was done after 12 months . The primary objective was to compare the effect of the surgeries on LUTS using the final scores of the International Consultation on Incontinence Question naire Urinary Incontinence Short Form ( ICIQ-UI SF ) and Overactive Bladder Question naire ( OAB-V8 ) , as well as the analysis of the incapacitating urinary symptoms and ″de novo″ urinary symptoms after 12 months of surgery in both groups . RESULTS Although there was a different number of women in each group , r and omization was adequate , result ed in homogeneous groups that could be compared regarding socio demographic , clinical and gynecological ( POP-Q ) variables . Patients of both groups showed improvements regarding LUTS and QoL , whether using polypropylene mesh or not , based on the final scores of the ICIQ-UI SF and OAB-V8 question naires after 12-month follow-up . There were few incapacitating and ″de novo ″ urinary symptoms , without any significant statistical difference between both groups after 12 months of surgery . CONCLUSION There was a general improvement of LUTS and QoL in both groups after 12-month follow-up . However , there was no significant difference of LUTS , as well as the more incapacitating and ″de novo ″ urinary symptoms between both groups after 12 months of surgery PURPOSE To revise the 2003 version of the American Urological Association 's ( AUA ) Guideline on the management of benign prostatic hyperplasia ( BPH ) . MATERIAL S AND METHODS From MEDLINE ® search es of English language publications ( January 1999 through February 2008 ) using relevant MeSH terms , articles concerning the management of the index patient , a male ≥45 years of age who is consulting a healthcare provider for lower urinary tract symptoms ( LUTS ) were identified . Qualitative analysis of the evidence was performed . Selected studies were stratified by design , comparator , follow-up interval , and intensity of intervention , and meta-analyses ( quantitative synthesis ) of outcomes of r and omized controlled trials were planned . Guideline statements were drafted by an appointed expert Panel based on the evidence . RESULTS The studies varied as to patient selection ; r and omization ; blinding mechanism ; run-in periods ; patient demographics , comorbidities , prostate characteristics and symptoms ; drug doses ; other intervention characteristics ; comparators ; rigor and intervals of follow-up ; trial duration and timing ; suspected lack of applicability to current US practice ; and techniques of outcomes measurement . These variations affected the quality of the evidence review ed making formal meta- analysis impractical or futile . Instead , the Panel and extractors review ed the data in a systematic fashion and without statistical rigor . Diagnosis and treatment algorithms were adopted from the 2005 International Consultation of Urologic Diseases . Guideline statements concerning pharmacotherapies , watchful waiting , surgical options and minimally invasive procedures were either up date d or newly drafted , peer review ed and approved by AUA Board of Directors . CONCLUSIONS New pharmacotherapies and technologies have emerged which have impacted treatment algorithms . The management of LUTS/BPH continues to evolve
Studies revealed both structural and functional alterations in bladders from patients with LUTS symptoms or animals with experimentally induced bladder dysfunction .
In particular , the urothelium and the suburothelial space , containing afferent nerve fibres and interstitial cells , have been found to form a functional unit that is essential in the process of bladder function .
Various imbalances within this suburothelial complex have been identified as significant contributors to the generation of storage LUTS , along with potential abnormalities of central function
CONTEXT The focus of clinical underst and ing and management of male storage lower urinary tract symptoms ( LUTS ) has shifted from the prostate to the bladder .
This is mirrored by an increasing body of experimental evidence suggesting that the bladder is the central organ in the pathogenesis of LUTS .
OBJECTIVE A systematic review of the literature available on pathophysiologic aspects of storage LUTS .