***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVES To assess the efficacy , safety , and tolerability of fesoterodine 4 and 8 mg once daily ( QD ) compared with placebo in Asian subjects with overactive bladder ( OAB ) after 12 weeks of treatment . METHODS This phase II , dose-finding study consisted of a 2-week placebo run-in period followed by a 12-week , r and omized , double-blind , placebo-controlled , treatment period . Eligible subjects were aged ≥20 years with ≥8 micturitions per 24 h and ≥1 urgency urinary incontinence ( UUI ) episodes per 24 h reported in a 3-day diary . The subjects were r and omized to receive placebo , fesoterodine 4 mg , or fesoterodine 8 mg QD for 12 weeks . RESULTS Of 1232 subjects who entered the placebo run-in period , 951 received double-blind treatment . The mean number of UUI episodes per 24 h at baseline was 2.2 among the three treatment groups . The two fesoterodine groups showed statistically significant decreases from baseline in the mean number of UUI episodes per 24 h at week 12 ( primary endpoint ) compared with placebo . Most all-causality adverse events ( e.g. dry mouth and constipation ) were mild or moderate . The percentage of subjects with severe adverse events was low and similar among the treatment groups ( placebo , 1.3 % ; fesoterodine 4 mg , 1.9 % ; fesoterodine 8 mg , 1.0 % ) . CONCLUSION Fesoterodine 4 and 8 mg QD were significantly better than placebo in improving OAB symptoms . Overall , the two fesoterodine dosing regimens were well tolerated . These results suggest that fesoterodine 4 and 8 mg QD are effective and well-tolerated treatments for OAB in Asian subjects The effects of renal impairment on the pharmacokinetics of a single 4-mg oral dose of fesoterodine are assessed in 8 healthy subjects and 8 subjects each with mild , moderate , or severe renal impairment . Compared with findings in healthy subjects , the maximum concentration in plasma of 5-hydroxymethyl tolterodine ( 5-HMT ) , the principal active moiety of fesoterodine , increases by 1.4- , 1.5- , and 2.0-fold and area under the curve increases by 1.6- , 1.8- , and 2.3-fold in subjects with mild , moderate , and severe renal impairment , respectively . There is a clear correlation between the renal clearance of 5-HMT and creatinine clearance . The median time of observed maximum drug concentration ( 5 - 6 hours ) and mean terminal half-life ( 6 - 7 hours ) of 5-HMT are unaffected by renal impairment . The unbound fraction of 5-HMT in plasma ( 0.43 - 0.54 ng/mL ) is comparable across all groups . In conclusion , because of the involvement of both metabolic and renal elimination pathways , only modest increases in 5-HMT exposures are observed in patients with renal impairment The authors ' aim in this study was to analyze the association of nocturia with overweight and obesity . In 2003 - 2004 , a question naire was mailed to 6,000 r and omly selected Finns aged 18 - 79 years who were identified from the Finnish Population Register Centre . Information on nocturia was collected through question naires using the Danish Prostatic Symptom Score and the American Urological Association Symptom Index . Self-reported body weight and height were used to calculate body mass index ( BMI ; weight (kg)/height (m)2 ) . Subjects were classified on the basis of BMI as nonoverweight ( BMI < 25 ) , overweight ( BMI 25 - 29.9 kgm2 ) , or obese ( BMI > or=30 ) . Of the 6,000 subjects , 62.4 % participated . Among men , the age-st and ardized prevalence of nocturia , defined as at least one void per night , was 33.4 % ( 95 % confidence interval ( CI ) : 28.5 , 38.3 ) in the nonoverweight , 35.8 % ( 95 % CI : 31.4 , 40.1 ) in the overweight , and 48.2 % ( 95 % CI : 38.8 , 57.6 ) in the obese . Among women , the corresponding figures were 37.2 % ( 95 % CI : 33.0 , 41.5 ) in the nonoverweight , 48.3 % ( 95 % CI : 42.5 , 54.2 ) in the overweight , and 53.6 % ( 95 % CI : 43.9 , 63.2 ) in the obese . The associations remained similar when nocturia was defined as two or more voids per night . The age-st and ardized attributable fraction ( population ) of increased BMI for nocturia was 17.7 % for men and 18.5 % for women , corresponding to an 8.5 % increase in the crude prevalence of nocturia in men and a 13.9 % increase in women . The authors conclude that obesity is associated with increased nocturia , more strongly among women than among men In a case-control study with prevalence sampling , the authors explored the correlates for nocturia and their population -level impact . In 2003–2004 , question naires were mailed to 6,000 subjects ( aged 18–79 years ) r and omly identified from the Finnish Population Register ( 62.4 % participated ; 53.7 % were female ) .  Question naires contained items on  medical conditions , medications  , lifestyle ,  sociodemographic  and reproductive factors  , urinary symptoms , and snoring . Nocturia was defined as ≥2 voids/night . In age-adjusted analyses , factors associated with nocturia were entered into a multivariate model . Backward elimination was used to select variables for the final model , with adjustment for confounding . Although numerous correlates were identified , none affected ≥50 % of nocturia cases of both sexes . The factors with the greatest impact at the population level were ( urinary ) urgency ( attributable number/1,000 subjects ( AN ) = 24 ) , benign prostatic hyperplasia ( AN = 19 ) , and snoring ( AN = 16 ) for men and overweight and obesity ( AN = 40 ) , urgency ( AN = 24 ) , and snoring ( AN = 17 ) for women . Moreover , correlates included prostate cancer and antidepressant use for men , coronary artery disease and diabetes for women , and restless legs syndrome and obesity for both sexes . Although several correlates were identified , none accounted for a substantial proportion of the population burden , highlighting the multifactorial etiology of nocturia PURPOSE We evaluated the efficacy and safety of flexible dose fesoterodine in medically complex vulnerable elderly subjects with urgency urinary incontinence . MATERIAL S AND METHODS In this 12-week , r and omized , double-blind , flexible dose , placebo controlled trial , subjects were community dwelling men and women 65 years old or older . Subjects had scores of 3 or more on the VES-13 ( Vulnerable Elders Survey ) and 20 or more on the MMSE ( Mini-Mental State Examination ) , and 2 to 15 urgency urinary incontinence episodes and 8 or more micturitions per 24 hours on 3-day baseline diaries . Subjects r and omized to fesoterodine  received 4 mg once daily for 4 weeks and could then increase to 8 mg based on discussion with the investigator . Subjects receiving 8 mg could decrease the dose to 4 mg at any time ( sham escalation and de-escalation for placebo ) . The primary outcome measure was change in daily urgency urinary incontinence episodes . Secondary outcomes included changes in other diary variables and patient reported quality of life measures . Safety evaluations included self-reported symptoms and post-void residual volume . RESULTS A total of 562 patients were r and omized ( mean age 75 years , 50.4 % age 75 years or greater ) . Subjects had high rates of comorbidities , polypharmacy and functional impairment .  At week 12 the fesoterodine group had significantly greater improvements in urgency urinary incontinence episodes per 24 hours ( -2.84 vs -2.20 , p = 0.002 ) and most other diary variables and quality of life , as well as a higher diary dry rate ( 50.8 % vs 36.0 % , p = 0.002 ) . Adverse effects were generally similar to those of younger population s including risk of urinary retention . CONCLUSIONS To our knowledge this is the first antimuscarinic study in a community based , significantly older , medically complex elderly population with urgency urinary incontinence . Flexible dose fesoterodine significantly improved urgency urinary incontinence episodes and other outcomes vs placebo , and was generally well tolerated Aims To assess fesoterodine 8 mg efficacy over time and vs. placebo in subjects with overactive bladder ( OAB ) who responded suboptimally to tolterodine extended release ( ER ) 4 mg . Methods In a 12-week , double-blind trial , subjects with self-reported OAB symptoms for ≥ 6 months , mean of ≥ 8 micturitions and ≥ 2 to < 15 urgency urinary incontinence ( UUI ) episodes/24 h , and suboptimal response to tolterodine ER 4 mg ( defined as ≤ 50 % reduction in UUI episodes during 2-week run-in ) were r and omised to fesoterodine ( 4 mg for 1 week , 8 mg for 11 weeks ) or placebo once daily . Change from baseline to week 12 in UUI episodes ( primary end-point ) was analysed in step-wise fashion : first , baseline vs. week 12 for fesoterodine ; if significant , then change from baseline to week 12 for fesoterodine vs. placebo . Results By week 12 , subjects receiving fesoterodine 8 mg had significantly greater improvement from baseline vs. placebo in UUI episodes , urgency episodes and scores on the Patient Perception of Bladder Control , Urgency Perception Scale and OAB Question naire Symptom Bother and Health-Related Quality of Life scales and domains ( all p < 0.05 ) . 50 % and 70 % UUI responder rates were also significantly higher with fesoterodine 8 mg vs. placebo at week 12 ( p < 0.05 ) . Dry mouth ( placebo , 4 % , 12/301 ; fesoterodine , 16.6 % , 51/308 ) and constipation ( placebo , 1.3 % , 4/301 ; fesoterodine , 3.9 % , 12/308 ) were the most frequent adverse events . Conclusions Subjects who responded suboptimally to tolterodine ER 4 mg showed significant improvements in UUI and other OAB symptoms and patient-reported outcomes , with good tolerability , during treatment with fesoterodine 8 mg vs. placebo Purpose Diurnal variation can affect drug pharmacokinetics . Fesoterodine is a new antimuscarinic drug for the treatment of overactive bladder ( OAB ) . We estimated the relative bioavailability of 5-hydroxymethyl tolterodine ( 5-HMT ) , the active metabolite of fesoterodine , following nighttime and daytime administration . Methods In this r and omized , open-label , two – period , two – treatment crossover , single-dose study , healthy subjects received daytime and nighttime oral dosing of fesoterodine 8-mg sustained-release tablets , separated by a minimum 60-h washout period . Blood sample s for 5–HMT PK determination were collected before dosing and at specified intervals up to 48 h postdose . Safety was assessed by adverse event ( AE ) reports . Results Fourteen subjects completed the study . Plasma concentration versus time profiles ( AUC ) of 5-HMT were similar for daytime and nighttime dosing . Mean $ $ AU{C_\infty } $ $ 5-HMT values were 47.9 and 51.4 ng h/mL for nighttime and daytime dosing , respectively ; the mean time to reach maximum concentration ( Cmax ) values were 3.9 and 5.0 ng/mL , respectively . Nighttime versus daytime $ $ AU{C_\infty } $ $ and Cmax ratios of 5-HMT were 93 and 79 % , respectively ; 90 % confidence intervals ( CIs ) indicated equivalence for $ $ AU{C_\infty } $ $ but not for Cmax . The median time to reach maximum concentration ( Tmax ) was 5.0 h for both dosing regimens , and the mean terminal elimination half-life ( T½ ) was 5.9 and 5.7 h for nighttime and daytime dosing , respectively . Seven treatment-related AEs , most commonly headache , occurred in five subjects . Conclusions The AUC values for daytime and nighttime administration of fesoterodine were equivalent . The 21 % reduction in the Cmax for nighttime dosing is unlikely to be clinical ly relevant . No safety issues were apparent . These results support both daytime and nighttime administration of fesoterodine for OAB treatment AIMS Our objective was to compare the efficacy and safety of imidafenacin over fesoterodine in patients with overactive bladder ( 
    Output:
    
Prospect i ve trials in specific patient population s indicated beneficial effects of fesoterodine in elderly patients , vulnerable elderly patients , patients dissatisfied with or with a suboptimal response to previous antimuscarinic therapy , patients with urge urinary incontinence ( UUI ) or nocturnal urgency , and men with persistent LUTS during alpha-blocker treatment .
The most common adverse events during fesoterodine treatment are dry mouth and constipation .
CONCLUSIONS Extensive evidence demonstrates the efficacy and safety of fesoterodine in relieving OAB symptoms , including urgency , urinary frequency , UUI , and nocturnal urgency , in patients with various clinical and demographic profiles .