tolterodine-tartrate and Urinary-Retention

The aim of the present review article was to summarize the efficacy and tolerability for mirabegron 50 mg over 12 weeks and 1 year versus placebo (SCORPIO) or tolterodine ER 4 mg (SCORPIO and TAURUS). After a 2-week placebo run-in, adults with overactive bladder symptoms for ≥3 months were randomized if, during a 3-day micturition diary period before baseline, they had an average of ≥8 micturitions/24 h and ≥3 urgency episodes. Efficacy end-points were change from baseline to each study visit and final visit in incontinence, micturitions, volume voided/micturition, urgency incontinence, urgency (grades 3 or 4), level of urgency and nocturia. Additional secondary efficacy variables included patient-reported outcomes. Safety variables included changes in treatment-emergent adverse events and vital signs. For SCORPIO, statistically significant improvements from baseline in efficacy variables and patient-reported outcomes were seen with mirabegron versus placebo from week 4, and were maintained over time. For TAURUS, numerical improvements in efficacy were evident from month 1, and were maintained throughout 12 months. Treatment-emergent adverse events incidence was similar between groups, except for dry mouth, which was reported by fourfold (SCORPIO) and threefold (TAURUS) more patients taking tolterodine than mirabegron. Mirabegron 50 mg for 12 weeks was associated with statistically significant improvements in objective measures of efficacy and patient-reported outcomes. At final visit, improvements with mirabegron 50 mg were statistically greater versus placebo. The efficacy profile of mirabegron 50 mg appears to be maintained over 12 months.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Benzhydryl Compounds; Cresols; Double-Blind Method; Drug Administration Schedule; Female; Headache; Humans; Hypertension; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Thiazoles; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Retention; Urinary Tract Infections; Urination; Xerostomia

To identify predictors of successful first-line antimuscarinic monotherapy for patients with enlarged prostate and predominant storage symptoms.. Men aged ≥ 50 years with total International Prostate Symptom Score (IPSS-T) ≥ 8, total prostate volume (TPV) ≥ 20 mL, IPSS quality of life (QOL) index ≥ 2, IPSS voiding to storage (IPSS-V/S) subscore ratio ≤ 1, and post-void residual (PVR) ≤ 250 mL were recruited into a prospective open-label study. All men received tolterodine ER (4 mg) daily. Global response assessment (GRA) ≥ 1 after treatment was considered successful treatment and an indication for continued antimuscarinic monotherapy.. One hundred ninety-seven men aged 50-89 years (average TPV 44.4 mL) received first-line tolterodine monotherapy. Mean IPSS-T, IPSS storage (IPSS-S) subscore, and QOL improved significantly at 2, 4, and 12 weeks. Average PVR increased significantly; no patient developed acute urinary retention. One hundred thirty-six patients (69.0%) showed improvement (GRA ≥ 1) at both 2 and 4 weeks. Regression analysis showed that IPSS-S (P = .039) and maximum urine flow (Qmax, P = .033) were significant predictors of therapeutic success. Patients with smaller baseline TPV, higher IPSS-S, and higher Qmax had significantly higher treatment success rates.. First-line antimuscarinic monotherapy is safe and effective within 12 weeks in selected patients with benign prostatic hyperplasia (BPH) Higher baseline IPSS-S, higher baseline Qmax, and lower TPV were predictors of successful antimuscarinic monotherapy.

Topics: Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Endosonography; Follow-Up Studies; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Quality of Life; Surveys and Questionnaires; Tolterodine Tartrate; Treatment Outcome; Urinary Retention

Despite several antimuscarinic treatment options for overactive bladder (OAB), there is still a need for distinct treatment approaches to manage this condition. Mirabegron, a β(3)-adrenoceptor agonist, has demonstrated efficacy and tolerability for up to 12 wk in phase 3 trials.. To assess the 12-mo safety and efficacy of mirabegron.. Patients ≥ 18 yr of age with OAB symptoms for ≥ 3 mo.. After a 2-wk single-blind placebo run-in, patients with eight or more micturitions per 24h and three or more urgency episodes in a 3-d micturition diary were randomized 1:1:1 to once-daily mirabegron 50mg, mirabegron 100mg, or tolterodine extended release (ER) 4 mg for 12 mo.. Primary variable: incidence and severity of treatment-emergent AEs (TEAEs). Secondary variables: change from baseline at months 1, 3, 6, 9, and 12 in key OAB symptoms.. A total of 812, 820, and 812 patients received mirabegron 50mg, mirabegron 100mg, and tolterodine ER 4 mg, respectively. Baseline demographic and OAB characteristics were similar across groups. TEAEs were reported in 59.7%, 61.3%, and 62.6% of patients, respectively; most were mild or moderate. Serious TEAEs were reported in 5.2%, 6.2%, and 5.4% of patients, respectively. The most common TEAEs were similar across groups. Dry mouth was reported by 2.8%, 2.3%, and 8.6% of patients, respectively. Adjusted mean changes from baseline to final visit in morning systolic blood pressure were 0.2, 0.4, and -0.5mm Hg for mirabegron 50mg, 100mg, and tolterodine ER 4 mg, respectively. Mirabegron and the active control, tolterodine, improved key OAB symptoms from the first measured time point of 4 wk, and efficacy was maintained throughout the 12-mo treatment period. The study was not placebo controlled, which was a limitation.. The safety and tolerability of mirabegron was established over 1 yr, with sustained efficacy observed over this treatment period.. ClinicalTrials.gov identifier: NCT00688688.

Topics: Acetanilides; Adrenergic beta-3 Receptor Agonists; Aged; Benzhydryl Compounds; Constipation; Cresols; Delayed-Action Preparations; Double-Blind Method; Female; Headache; Humans; Hypertension; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Single-Blind Method; Thiazoles; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Retention; Xerostomia

To determine the efficacy of toterodine extended release (ER) treatment for 1 year in older men with benign prostatic hyperplasia (BPH) and storage symptoms treated with alpha-blockers and/or 5-alpha-reductase inhibitors (5ARI).. Men aged over 70 years with BPH/bladder outlet obstruction (BOO) and clinical storage symptoms were randomly treated with or without tolterodine ER in combination with alpha-blockers and/or 5ARI for 12 months. Among them, 50 patients (group 1) received additive tolterodine extended release (ER) 4 mg q.d., another 87 patients (group 2) did not. All patients had a baseline and 12th month post-treatment evaluation, which comprised of uroflowmetry, post-void residual (PVR) volume, International Prostate Symptom Score (IPSS), and quality of life index (QoL-I), transrectal ultrasound of the prostate and serum prostate specific antigen.. One hundred thirty-seven of 153 enrolled patients with a mean age of 74.9 years completed the study. Treatment benefit demonstrated in both groups included deceased total, voiding and storage IPSS scores, increased peak urinary flow rate and deceased QoL-I. Inter-group difference was only observed on the storage domain of IPSS score (P = 0.012). The mean PVR after treatment did not significantly differ between two groups. Two patients of group 1 and three of group 2 developed acute urinary retention. Among group 1, six patients discontinued tolterodine ER for intolerable dry mouth; among group 2, three patients reported dizziness.. This longer comparative study indicated that additive treatment with tolterodine ER in older men with BPH/BOO and significant storage symptoms is a beneficial and safe therapeutic option.

Topics: Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Humans; International Cooperation; Male; Muscarinic Antagonists; Phenylpropanolamine; Prostatic Hyperplasia; Quality of Life; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder, Overactive; Urinary Retention

To evaluate the dose-response relationship and safety/tolerability of solifenacin succinate (YM905) in the treatment of overactive bladder (OAB), and to compare its efficacy and safety/tolerability with tolterodine 2 mg twice daily.. This multicentre study included a 2-week single-blind placebo run-in, a 4-week double-blind placebo-controlled active treatment phase, and a 2-week follow-up. Men and women with an OAB and urodynamic evidence of detrusor overactivity were randomized to placebo or solifenacin 2.5, 5, 10 or 20 mg once daily, or tolterodine 2 mg twice daily.. Of 265 patients enrolled, 225 were randomized and 192 completed the study. Solifenacin 5, 10 and 20 mg produced statistically significant (P < 0.05) improvements in voids/24 h vs placebo, whereas tolterodine did not; the mean change with tolterodine was between those with solifenacin 2.5 and 5 mg. The outcome was similar for the mean change from baseline to endpoint in mean volume voided/void. For incontinence and urgency episodes/24 h the solifenacin dose groups showed numerically superior changes vs placebo; the mean effects with tolterodine were generally smaller than with solifenacin. Most of the efficacy effect of solifenacin was evident at 2 weeks. Quality-of-life outcomes supported the efficacy results. Solifenacin 5 and 10 mg were well tolerated; there were no serious treatment-related adverse events. The incidence of dry mouth was 14% for solifenacin 5 and 10 mg, 2.6% for placebo and 24% for tolterodine.. In this study, the 5- and 10-mg doses of solifenacin appeared to be the most clinically effective for treating OAB, considering the balance between efficacy, quality of life and tolerability. From the results of this study solifenacin 5 and 10 mg were selected for further evaluation in large-scale phase 3 studies.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Quinuclidines; Single-Blind Method; Solifenacin Succinate; Tetrahydroisoquinolines; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder Diseases; Urinary Retention; Urination

To compare the efficacy of tolterodine plus simplified bladder training (BT) with tolterodine alone in patients with an overactive bladder.. In a multicentre, single-blind study at 51 Scandinavian centres, 505 patients aged >or= 18 years with symptoms of urinary frequency (>or= 8 micturitions/24 h) and urgency, with or without urge incontinence, were randomized to oral treatment with either tolterodine 2 mg twice daily plus simplified BT or tolterodine alone. Changes in voiding diary variables were evaluated after 2, 12 and 24 weeks of treatment. The patients' perceptions of their bladder symptoms and tolerability (adverse events) were also determined.. In all, 501 patients (75% women) were evaluable on an intention-to-treat basis (244 on tolterodine + BT and 257 on tolterodine alone). Tolterodine significantly reduced the voiding frequency and increased the volume voided per void at all sample times; these effects were significantly increased by adding BT. At the end of the study the median percentage reduction in voiding frequency was greater with tolterodine + BT than with tolterodine alone (33% vs 25%, P < 0.001), while the median percentage increase in volume voided per void was 31% with tolterodine + BT and 20% with tolterodine alone (P < 0.001). There was a median of 81% fewer incontinence episodes than at baseline with tolterodine alone, which was not significantly different from that with tolterodine + BT (- 87%). The two groups had comparable median percentage reductions in urgency episodes. Some 76% of patients on tolterodine + BT reported an improvement in their bladder symptoms relative to baseline, compared with 71% on tolterodine alone. Tolterodine was well tolerated; the most common adverse event was mild dry mouth.. Tolterodine 2 mg twice daily is an effective and well tolerated treatment for an overactive bladder, the effectiveness of which can be augmented by a simplified BT regimen.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Behavior Therapy; Benzhydryl Compounds; Combined Modality Therapy; Cresols; Female; Humans; Male; Middle Aged; Muscarinic Antagonists; Phenylpropanolamine; Single-Blind Method; Tolterodine Tartrate; Treatment Outcome; Urinary Bladder Diseases; Urinary Retention

Antimuscarinic (AM) and beta-3-agonist (B3A) treatment are the standard first-line pharmacological treatment used to manage overactive bladder (OAB) patients. Aim of our study was to analyze real-life data of adverse events related to AMs and B3A reported on Eudra-Vigilance (EV) Database.. EV database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). We recorded the number of AEs for antimuscarinic and beta-3-agonist per category and severity until January 2021.. Overall, 2313 AEs were reported for oxybutinin, 5129 for solifenacin, 2483 for tolterodine, 3523 for fesoterodine, 787 for trospium, 621 for propiverine and 7213 for mirabegron. Urinary retention was higher for fesoterodine (43%) and tolterodine (23%) when compared to solifenacin (10%), mirabegron (11%) and oxybutinin (4%). Cognitive disorder was uncommon for all the analyzed drugs analyzed. Regarding anticolinergic AEs: vision blurred, dry mouth and constipation were higher for AMs when compared to mirabegron. Their prevalence was higher in female patients. Mirabegron presented a higher risk of hypertension (7%) when compared to oxybutinin (2%, P<0.01), solifenacin (2%, P<0.01), tolterodine (2%, P<0.01) and fesoterodine (1%, P<0.01); the rate of hypertension was higher in females (63%) than males (29%) (P<0.01). The risk of acute urinary retention was also significantly higher (15% vs. 10%, P<0.01) in older patients (>85 years).. Real life data is consistent with registry studies regarding the rate of AEs related to antimuscarinic and beta-3-agonist. However some differences were observed. Female patients present higher rates of AEs when compared to male patients. The risk of acute urinary retention was particularly evident in the octogenarians.

Topics: Aged; Aged, 80 and over; Female; Humans; Hypertension; Male; Muscarinic Antagonists; Solifenacin Succinate; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Retention

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.. 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.. 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 randomized 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).. Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables.. 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 clinically or statistically significant changes in Q(max) or PVR; incidence of acute urinary retention (AUR) was low in all groups (

Topics: Adrenergic alpha-Antagonists; Adult; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Diuresis; Drug Therapy, Combination; Humans; Male; Middle Aged; Multicenter Studies as Topic; Muscarinic Agonists; Organ Size; Phenylpropanolamine; Prostate; Randomized Controlled Trials as Topic; Sulfonamides; Tamsulosin; Tolterodine Tartrate; Urinary Bladder, Overactive; Urinary Retention

In this open label, prospective study we determined the efficacy and tolerability of tolterodine extended release (ER) in men with benign prostatic hyperplasia (BPH) and lower urinary tract symptoms (LUTS) in whom previous alpha-blocker therapy had failed.. A total of 43 consecutive men with BPH and LUTS in whom a mean of 5.7 months of alpha-blocker therapy had failed due to adverse events (11) or a lack of efficacy (32) received tolterodine ER (4 mg daily) for 6 months. Primary efficacy end points were American Urological Association symptom score, and mean daytime and nighttime micturition frequency. Secondary end points were the peak urinary flow rate, post-void residual volume, the incidence of urinary retention, total score on the erectile function domain of the International Index of Erectile Function and adverse events.. A total of 39 men (91%) with a mean age of 61 years completed the 6-month trial. Mean 24-hour micturition frequency decreased from 9.8 to 6.3 voids and nocturia decreased from 4.1 to 2.9 episodes nightly. Significant changes in mean American Urological Association symptom scores (-6.1), the peak urinary flow rate (1.9 ml per second) and post-void residual volume (-22 ml) were also observed. Of the men 27 (63%) were potent at baseline and 29 (67%) were potent after 6 months of tolterodine ER treatment. Mean International Index of Erectile Function erectile function domain scores increased (6.9). Four men (9%) discontinued therapy because of intolerable dry mouth. There were no reports of urinary retention.. Treatment with tolterodine ER in men with BPH and LUTS may be a reasonable therapeutic option as initial therapy or after failed treatment with alpha-blockers.

Topics: Adrenergic beta-Antagonists; Aged; Aged, 80 and over; Benzhydryl Compounds; Cresols; Delayed-Action Preparations; Humans; Incidence; Male; Middle Aged; Muscarinic Antagonists; Penile Erection; Phenylpropanolamine; Prospective Studies; Prostatic Hyperplasia; Time Factors; Tolterodine Tartrate; Treatment Outcome; Urinary Retention; Urination