Self-management for men with lower urinary tract symptoms Intermittent alpha-blocker therapy in the treatment of men with lower urinary tract symptoms. Long-term efficacy and safety of a combination of sabal and urtica extract for lower urinary tract symptoms—a placebo-controlled, double-blind, multicenter trial 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. Comparison of 25 and 75 mg/day naftopidil for lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective, randomized controlled study. Combination therapy with doxazosin and tenoxicam for the management of lower urinary tract symptoms. Eliciting preferences for drug treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia. Efficacy and safety of combined therapy with terazosin and tolteradine for patients with lower urinary tract symptoms associated with benign prostatic hyperplasia: a prospective 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 Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia: Combined Treatment with Fesoterodine Fumarate Extended-Release and Tamsulosin - A Prospective Study 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 Behavioral and drug therapy for urinary incontinence. The effect of benign lower urinary tract symptoms on subsequent prostate cancer testing and diagnosis. [A Crossover Comparison Study on Lower Urinary Tract Symptoms with Overactive Bladder Secondary to Benign Prostatic Hyperplasia: Naftopidil versus Tamsulosin with Solifenacin]. Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial Effect of Improvement in Lower Urinary Tract Symptoms on Sexual Function in Men: Tamsulosin Monotherapy vs. Combination Therapy of Tamsulosin and Solifenacin
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 OBJECTIVES To determine the safety and efficacy of intermittent alpha-blocker therapy in men with lower urinary tract symptoms ( LUTS ) in a prospect i ve study . Alpha-blockers have been demonstrated to be safe and effective in the treatment of men with LUTS . To date , the role of varying dosing regimens in responding patients has not been well studied . METHODS Men with LUTS were entered into this prospect i ve open label , parallel , r and omized trial . In phase 1 , patients were treated with alfuzosin , 2.5 mg three times daily for 3 months . In phase 2 , those patients who had a significant therapeutic response were r and omized into one of the following three groups : ( 1 ) maintenance of alfuzosin ; ( 2 ) alfuzosin every other day ; and ( 3 ) discontinuation of alfuzosin ( ie , no treatment ) . Patients were followed up for a total of 6 months . Parameters of evaluation included the International Prostate Symptom Score ( IPSS ) , global satisfaction , peak urinary flow rate ( Qmax ) , and adverse events . RESULTS At 3 months , there were 79 patients who were categorized as having obtained a therapeutic response :  IPSS decreased to 7.6 + /- 3.2 and Qmax increased to 11.3 + /- 2.9 mL/s . After r and omization , IPSS was 7.1 + /- 2.9 and 6.5 + /- 2.5 for group 1 ; 6.5 + /- 3.2 and 6.7 + /- 2.1 for group 2 ; and 11.4 + /- 4.8 and 12.3 + /- 4.9 for group 3 at 3 and 6 months , respectively . Qmax was 12.7 + /- 4.8 and 11.7 + /- 5.2 mL/s for group 1 ; 12.2 + /- 3.9 and 11.9 + /- 3.7 mL/s for group 2 ; and 9.7 + /- 2.5 and 9.3 + /- 2.1 mL/s for group 3 at 3 and 6 months , respectively . Global satisfaction at 6 months was the same for groups 1 and 2 . There were no differences in adverse events among the three groups . CONCLUSIONS In men with LUTS who responded to alfuzosin , changing the dosing regimen from daily to once every other day result ed in similar efficacy and safety at 3 and 6 months . By contrast , complete cessation of alfuzosin result ed in recurrence of both symptoms and impaired urinary flow . These data provide evidence that in responding patients , intermittent alpha-blocker therapy may be a reasonable therapeutic regimen . The role of intermittent alpha-blocker therapy using other agents , as well as in a large cohort of men with LUTS , remains to be determined The efficacy and tolerability of a fixed combination of 160 mg sabal fruit extract WS 1473 and 120 mg urtica root extract WS 1031 per capsule ( PRO 160/120 ) was investigated in elderly , male patients suffering from lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia in a prospect i ve multicenter trial . A total of 257 patients ( 129 and 128 , respectively ) were r and omized to treatment with PRO 160/120 or placebo  ( 127 and 126 were evaluable for efficacy ) . Following a single-blind placebo run-in phase of 2 weeks , the patients received 2 × 1 capsule/day of the study medication under double-blind conditions over a period of 24 weeks . Double-blind treatment was followed by an open control period of 24 weeks during which all patients were administered PRO 160/120 . Outcome measures for treatment efficacy included the assessment of the patients ’ LUTS by means of the I-PSS self-rating question naire and a quality of life index as well as uroflow and sonographic parameters . Using the International Prostate Symptom Score ( I-PSS ) , patients treated with PRO 160/120 exhibited a substantially higher total score reduction after 24 weeks of double-blind treatment than patients of the placebo group ( 6 points vs 4 points ; P=0.003 , one tailed ) with a tendency in the same direction after 16 weeks . This applied to obstructive as well as to irritative symptoms , and to patients with moderate or severe symptoms at baseline . Patients r and omized to placebo showed a marked improvement in LUTS ( as measured by the I-PSS ) after being switched to PRO 160/120 during the control period ( P=0.01 , one tailed , in comparison to those who had been treated with PRO 160/120 in the double-blind phase ) . The tolerability of PRO 160/120 was comparable to the placebo . In conclusion , PRO 160/120 was clearly superior to the placebo for the amelioration of LUTS as measured by the I-PSS . PRO 160/120 is advantageous in obstructive and irritative urinary symptoms and in patients with moderate and severe symptoms . The tolerability of the herbal extract was excellent 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 BACKGROUND The present study investigated the efficacy , safety , and utility of starting an alpha(1d)-selective antagonist , naftopidil , at 75 or 25 mg/day in patients with lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) . METHODS In this prospect i ve comparative study , the subjects comprised 153 patients with LUTS associated with BPH . Patients were r and omized to receive either 25 mg/day ( Group LD ) or 75 mg/day ( Group HD ) of naftopidil for 4 weeks . The lower urinary tract disease symptom score ( LUTDSS ) , the International Prostate Symptom Score ( IPSS ) , the Quality of life assessment index , the maximum flow rate ( Q(max ) ) , and the residual urine volume were compared between the groups . RESULTS In both groups , the LUTDSS and the IPSS were significantly improved at the endpoint and no significant intergroup differences were identified . However , the improvement in the Q(max ) was significantly better for Group HD than for Group LD . The overall efficacy did not differ significantly between the groups . The degree of improvement in voiding symptoms and LUTDSS among patients with moderate symptoms was significantly greater for Group HD than for Group LD . The frequency of adverse reactions did not differ significantly between the groups . CONCLUSIONS Starting administration at 75 mg/day rather than 25mg/day is helpful for LUTS associated with BPH for patients with moderate symptoms , particularly in improving voiding symptoms . The 75 mg/day administration was considered to be a recommendable therapeutic dose in some patients 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 PURPOSE There are 2 main medical preparations available for lower urinary tract symptoms result ing from benign prostatic hyperplasia ( BPH ) . Choosing between an alpha-blocker and a 5alpha-reductase inhibitor requires trade-offs between their attributes or characteristics . We investigated the relative importance of and trade-offs between the attributes of the 5alpha-reductase inhibitor dutasteride and alpha-blockers in community dwelling men using a vali date d technique . MATERIAL S AND METHODS A discrete choice experiment was administered to 211 men older than 40 years who were r and omly selected from the general United Kingdom population . Attributes investigated in the discrete choice experiment were time to symptom improvement , sexual and nonsexual side effects , the risks of acute urinary retention ( AUR ) and surgery , cost and prostate size decrease . Using regression analysis the relative importance of these attributes , the trade-offs that men are willing to make between these attributes and the willingness to pay for each attribute were estimated . RESULTS All attributes were important to respondents . The most important attribute was side effects . The least preferred side effects was impotence , followed by decreased libido and dizziness . Respondents were willing to wait 13 , 2 and 8 months longer for symptom improvement in exchange for decreased prostate size , and the risks of AUR and surgery , respectively . Men reporting moderate symptoms were less concerned about sexual side effects , time to symptom improvement and the risk of AUR compared with men reporting mild symptoms . CONCLUSIONS Given the attribute levels of BPH medical treatment , overall community dwelling men preferred the 5alpha-reductase inhibitor over alpha-blockers . In the interests of shared decision making it is important to consider the importance of eliciting the preferences of patients with BPH Background The primary objectives of the treatment for the  lower urinary tract symptoms ( LUTS ) associated with benign prostatic hyperplasia ( BPH ) are to produce rapid , sustained , and safe improvements in the symptoms that affect the quality of life in the majority of men over 50 . In this study , we evaluated the efficacy and safety of the combined therapy with terazosin ( & agr;1‐adrenergic receptor antagonist ) and tolterodine ( anticholinergic agent ) for LUTS associated with BPH . Methods This combination study included 69 patients diagnosed with LUTS associated with BPH based on the International Prostate Symptom Scores ( IPSS ) , urinary flow rate , prostate volume , urinary residual , and their serum prostate‐specific antigen levels .  Initially , 191 patients were treated with terazosin 2 mg once daily for one week . Those patients with continued LUTS after the initial treatment were allocated r and omly into two groups : terazosin group ( n=36 ) in which patients were treated with terazosin 2 mg once daily for six weeks , and combination group ( n=33 ) in which patients were treated with both terazosin 2 mg once daily and tolterodine 2 mg twice daily for 6 weeks . Results The IPSS were significantly improved in both groups after treatment , and the reduction of IPSS in the combination group was significantly greater than that in the terazosin group ( P<0.01 ) . A decrease in urgency , frequency and nocturia were the main contributory factors causing the reduction of IPSS in the combination group . The differences about the peak urinary flow rate and the residual urine from the baseline values were noted in both groups after treatment , but were not significant between the two groups . The incidence of adverse effects in the combination group was higher than that in the terazosin group . As expected the most common adverse effect was mouth dryness which was associated with anticholinergic drugs such as tolterodine . Conclusions Patients with LUTS associated BPH appear the improved IPSS after combined therapy with terazosin and tolterodine . This study , although short term and limited numbers of patients , provides evidence that the combined therapy with terazosin plus tolterodine is a good approach for meeting the objectives of rapid , sustained , and safe improvements in the LUTS associated with BPH . And the profile of patients in this study might be used as the indication of such combined therapy for LUTS associated with BPH without urodynamic evaluation 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 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 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 In a r and omized , controlled trial comparing biofeedback-assisted behavioral therapy and drug therapy with oxybutynin , both types of therapy were superior to placebo in older , community-dwelling women with urge or mixed incontinence .  Behavioral therapy significantly reduced incontinence compared with oxybutynin therapy ( 80.7 % vs 68.5 % , P = 0.04 ) . Patients expressed high levels of satisfaction with behavioral therapy , and 97 % were willing to continue this therapy indefinitely , compared with 55 % receiving drug therapy . Results of recent studies suggest that behavioral therapy without biofeedback or pelvic floor electrical stimulation also results in significant clinical benefits , which should make behavioral therapy a more practical approach in the general practice setting . Statistical analysis showed no significant relationship between posttreatment urodynamic changes and clinical outcomes , and thus , the mechanisms by which behavioral and drug therapies work remain unidentified . In a small trial of combination therapy , patients who received both drug and behavioral therapy experienced significant clinical improvements compared with the effects of monotherapy with either treatment 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 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 In an open-label extension of a r and omized , double-blind clinical trial , the long-term efficacy and tolerability of a fixed combination of 160 mg Sabal fruit extract WS 1473 and 120 mg Urtica root extract WS 1031 per capsule ( PRO 160/120 ) were investigated in elderly men with moderate or severe lower urinary tract symptoms ( LUTS ) caused by benign prostatic hyperplasia ( BPH ) . Two hundred and fifty-seven patients were r and omly treated with 2 × 1 capsule/day PRO 160/120 or placebo for 24 weeks , followed by a 24-week control period and a 48-week follow-up period in which all patients received PRO 160/120 . Efficacy measures included the assessment of LUTS [ International Prostate Symptom Score ( ( I-PSS ) self-rating question naire ] and uroflow and sonographic parameters . Two hundred and nineteen subjects participated in the follow-up . Between baseline and end of observation ( week 96 ) the I-PSS total score was reduced by 53 % ( P < 0.001 ) , peak and average urinary flow increased by 19 % ( P < 0.001 ) , and residual urine volume decreased by 44 % ( P = 0.03 ) . The incidence of adverse events during follow-up was one in 1,181 treatment days ; in only one event a causal relationship with intake of PRO 160/120 could not be excluded . Treatment with PRO 160/120 thus provides a clinical ly relevant benefit over a period of 96 weeks 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
EVIDENCE SYNTHESIS The most studied combination therapy for the treatment of male LUTS is the α1-adrenoceptor antagonist/5α-reductase inhibitor combination .
This combination seems to be more efficacious in terms of several outcome variables , in particular in men who have moderate-to-severe LUTS and are at risk of disease progression .
Also in terms of nocturia improvements , this combination is significantly more effective than the monotherapy .
The other often studied combination treatment , in both male and female patients with LUTS , was the combination of antimuscarinics ( in particular solifenacin ) and mirabegron .
This combination seems to be more effective in comparison with the monotherapies with respect to urinary incontinence and urgency urinary incontinence episodes and several other objective and subjective parameters , without relevant increase of adverse events .
The combination of hormone therapy and antimuscarinics in women with LUTS does not seem to be useful .
For the treatment of LUTS in men and women , combination therapy appears to be a promising option to optimize the efficacy of the available drugs for those who do not experience sufficient benefit with monotherapy .
This add-on scenario offers the possibility to have a more tailored approach to the management of LUTS , always seeking the optimal balance between efficacy and tolerability for a given patient .
PATIENT SUMMARY Some combination of drugs may offer advantages over monotherapies for the treatment of voiding and storage complaints in men and women
CONTEXT Several drugs are approved and available for the treatment of lower urinary tract symptoms ( LUTS ) in men and women .
However , the vast majority of available data , upon which the approval and recommendation in guidelines are based , considered only the role of the monotherapies and did not evaluate possible combination therapies .
OBJECTIVE This systematic review analyzes the efficacy and adverse events of combination therapies for male and female LUTS .