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Zhonghong Guan - One of the best experts on this subject based on the ideXlab platform.

  • superior efficacy of fesoterodine over Tolterodine extended release with rapid onset a prospective head to head placebo controlled trial
    BJUI, 2011
    Co-Authors: Steven A Kaplan, Zhonghong Guan, Martin Carlsson, Tim Schneider, Jenelle E. Foote, Jason Gong
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? A previous trial found greater efficacy with the maximum available dose of fesoterodine 8 mg compared with the maximum available dose of Tolterodine ER 4 mg and placebo for improving overactive bladder symptoms, and patient-reported outcomes were demonstrated by a recent placebo-controlled, head-to-head trial. The results of this trial, the largest to date to compare antimuscarinic efficacy, confirms the superior efficacy of fesoterodine 8 mg over Tolterodine ER 4 mg for the treatment of OAB symptoms, and further emphasize the clinical advantage of the availability of an additional 8-mg dose over single-dose Tolterodine ER 4 mg. OBJECTIVE • To show the superior efficacy of fesoterodine over Tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes. MATERIALS AND METHODS • In this 12-week, double-blind, double-dummy trial, subjects reporting >1 urgency urinary incontinence (UUI) episode and ≥8 micturitions per 24 h at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), Tolterodine ER 4 mg, or placebo. • Subjects completed 3-day bladder diaries, the Patient Perception of Bladder Condition (PPBC) and the Urgency Perception Scale (UPS) at baseline and weeks 1, 4 and 12 and the OAB Questionnaire at baseline and week 12. RESULTS • A total of 2417 subjects were randomized. At week 12, fesoterodine 8 mg showed superiority over Tolterodine ER 4 mg and placebo on UUI episodes (primary endpoint), micturitions, urgency and most other diary endpoints, and on the PPBC, UPS and all OAB Questionnaire scales and domains (all P < 0.05). • Superiority of fesoterodine 8 mg over Tolterodine ER 4 mg was seen as early as week 4 (3 weeks after escalation to fesoterodine 8 mg). At week 1, fesoterodine 4 mg was superior to placebo on most diary variables, the PPBC and the UPS (all P < 0.05). Dry mouth and constipation rates were 28% and 4% with fesoterodine, 13% and 3% with Tolterodine ER, and 5% and 2% with placebo. • Discontinuation rates as a result of adverse events were 5%, 3% and 2% for fesoterodine, Tolterodine ER and placebo, respectively. CONCLUSIONS • In this randomized study, which is the largest to compare antimuscarinic efficacy performed to date, fesoterodine 8 mg was superior to Tolterodine ER 4 mg for UUI episodes, micturitions and urgency episodes, as well as for self-reported patient assessments of bladder-related problems, urgency, symptom bother and health-related quality of life. • The superiority of fesoterodine 8 mg over Tolterodine ER 4 mg was observed as early as 3 weeks after escalation from fesoterodine 4 mg for most outcomes. These data may have important implications for the clinical management of OAB patients previously treated with Tolterodine ER.

  • comparison of fesoterodine and Tolterodine extended release for the treatment of overactive bladder a head to head placebo controlled trial
    BJUI, 2010
    Co-Authors: Sender Herschorn, Zhonghong Guan, Martin Carlsson, Jon D Morrow, Marina Brodsky, Steven Swift, Jason Gong
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVE To compare the efficacy and tolerability of fesoterodine 8 mg with Tolterodine extended-release (ER) 4 mg and placebo in a randomized clinical trial of patients with an overactive bladder (OAB). PATIENTS AND METHODS In this 12-week double-blind, double-dummy, placebo-controlled, randomized clinical trial, eligible patients reported OAB symptoms for ≥3 months and recorded ≥8 voids and ≥1 urgency urinary incontinence (UUI) episode per 24 h in 3-day bladder diaries at baseline. Patients were randomized in a 2:2:1 ratio to fesoterodine (4 mg for 1 week then 8 mg for 11 weeks); Tolterodine ER 4 mg; or placebo (with sham dose escalation for Tolterodine ER and placebo). Endpoints were changes from baseline to week 12 in UUI episodes (primary endpoint), total and nocturnal voids, urgency episodes, severe urgency episodes, and frequency-urgency sum per 24 h; mean voided volume per void (MVV); and the OAB questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS). Safety and tolerability were assessed and summarized over the 12-week study period. RESULTS Fesoterodine (636 patients) significantly improved UUI episodes at week 12 (primary endpoint) compared with Tolterodine ER (641 patients; P = 0.017) and placebo (313 patients; P < 0.001). Fesoterodine also produced significantly greater improvements than Tolterodine ER in MVV (P = 0.005). Fesoterodine significantly improved all diary endpoints compared with placebo (P < 0.001), except for nocturnal voids (P = 0.327). Tolterodine ER significantly improved all diary endpoints vs placebo (P < 0.001), except for nocturnal voids (P = 0.506) and MVV (P = 0.103). Diary dry rates (the proportion of patients reporting no UUI episodes at endpoint among those with one or more UUI episodes at baseline) were significantly higher with fesoterodine (64%) than with Tolterodine ER (57%; P = 0.015) and placebo (45%; P < 0.001). Improvements in PPBC, UPS and OAB-q scale and domain scores at week 12 were all significantly better with fesoterodine than placebo (all P < 0.001) and Tolterodine ER (all P < 0.05) except for the OAB-q Sleep domain vs Tolterodine ER (P = 0.081). Dry mouth and constipation rates were 28% and 5% in the fesoterodine group, 16% and 4% in the Tolterodine ER group, and 6% and 3% with placebo, respectively. Discontinuations due to treatment-emergent adverse events were 6%, 4% and 2% in the fesoterodine, Tolterodine ER, and placebo groups, respectively. CONCLUSION In patients with OAB, fesoterodine 8 mg showed superior efficacy over Tolterodine ER 4 mg and placebo in reducing UUI episodes (primary endpoint) and in improving most patient-reported outcome measures. Both active treatments were well tolerated.

  • combined effects of behavioral intervention and Tolterodine in patients dissatisfied with overactive bladder medication
    The Journal of Urology, 2009
    Co-Authors: Carl G Klutke, Zhonghong Guan, Kathryn L Burgio, Jean F Wyman, Franklin Sun, Sandra Berriman, Tamara Bavendam
    Abstract:

    Purpose: We assessed the effect of Tolterodine extended release plus behavioral intervention on treatment satisfaction and bladder diary variables in patients with overactive bladder who had been previously treated and were dissatisfied with Tolterodine or other antimuscarinics.Materials and Methods: This 16-week, multicenter, open label study included eligible patients 18 years old or older who reported overactive bladder symptoms 3 months or greater in duration, 8 or greater micturitions and 2 or greater urgency related micturitions per 24 hours, and 1 or greater urgency urinary incontinence episodes in a 5-day bladder diary at baseline as well as dissatisfaction with prior antimuscarinic medication. Patients received Tolterodine extended release plus self-administered behavioral intervention, consisting of an educational pamphlet with verbal reinforcement, for 8 weeks. Satisfied patients continued with this therapy and dissatisfied patients received Tolterodine extended release plus individualized beha...

  • Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
    European Urology, 2009
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-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) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, Tolterodine ER (4mg), tamsulosin (0.4mg), or Tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( 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 p 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 (≤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.

  • effects of serum psa on efficacy of Tolterodine extended release with or without tamsulosin in men with luts including oab
    Urology, 2008
    Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    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 ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized 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 (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥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 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 (

Steven A Kaplan - One of the best experts on this subject based on the ideXlab platform.

  • Tolterodine for the treatment of urge urinary incontinence.
    Expert opinion on pharmacotherapy, 2013
    Co-Authors: Dean Elterman, Steven A Kaplan, Bilal Chughtai, Jack Barkin
    Abstract:

    Introduction: Overactive bladder (OAB) and its resultant urge urinary incontinence (UUI) are significant problems that medically, psychologically and financially affect people. The constellation of symptoms comprising OAB affects ∼ 16% of the adult population and its prevalence increases with aging. The typical class of medications used to treat OAB is antimuscarinics. Areas covered: OAB medications, with a focus on Tolterodine for the treatment of UUI are reviewed. A thorough review of English language literature using EMBASE/Medline and PubMed has been performed. Expert opinion: Tolterodine provides a reasonable starting point when treating patients with OAB and UUI. Efficacy and tolerability are generally comparable between Tolterodine and other newer antimuscarinics. Tolterodine is a good option as part of the algorithm in the treatment of OAB and UUI.

  • superior efficacy of fesoterodine over Tolterodine extended release with rapid onset a prospective head to head placebo controlled trial
    BJUI, 2011
    Co-Authors: Steven A Kaplan, Zhonghong Guan, Martin Carlsson, Tim Schneider, Jenelle E. Foote, Jason Gong
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b What’s known on the subject? and What does the study add? A previous trial found greater efficacy with the maximum available dose of fesoterodine 8 mg compared with the maximum available dose of Tolterodine ER 4 mg and placebo for improving overactive bladder symptoms, and patient-reported outcomes were demonstrated by a recent placebo-controlled, head-to-head trial. The results of this trial, the largest to date to compare antimuscarinic efficacy, confirms the superior efficacy of fesoterodine 8 mg over Tolterodine ER 4 mg for the treatment of OAB symptoms, and further emphasize the clinical advantage of the availability of an additional 8-mg dose over single-dose Tolterodine ER 4 mg. OBJECTIVE • To show the superior efficacy of fesoterodine over Tolterodine extended release (ER) in a placebo-controlled overactive bladder (OAB) trial with predefined treatment comparisons for both diary measures and patient-reported outcomes. MATERIALS AND METHODS • In this 12-week, double-blind, double-dummy trial, subjects reporting >1 urgency urinary incontinence (UUI) episode and ≥8 micturitions per 24 h at baseline were randomized to fesoterodine (4 mg for 1 week, 8 mg for 11 weeks), Tolterodine ER 4 mg, or placebo. • Subjects completed 3-day bladder diaries, the Patient Perception of Bladder Condition (PPBC) and the Urgency Perception Scale (UPS) at baseline and weeks 1, 4 and 12 and the OAB Questionnaire at baseline and week 12. RESULTS • A total of 2417 subjects were randomized. At week 12, fesoterodine 8 mg showed superiority over Tolterodine ER 4 mg and placebo on UUI episodes (primary endpoint), micturitions, urgency and most other diary endpoints, and on the PPBC, UPS and all OAB Questionnaire scales and domains (all P < 0.05). • Superiority of fesoterodine 8 mg over Tolterodine ER 4 mg was seen as early as week 4 (3 weeks after escalation to fesoterodine 8 mg). At week 1, fesoterodine 4 mg was superior to placebo on most diary variables, the PPBC and the UPS (all P < 0.05). Dry mouth and constipation rates were 28% and 4% with fesoterodine, 13% and 3% with Tolterodine ER, and 5% and 2% with placebo. • Discontinuation rates as a result of adverse events were 5%, 3% and 2% for fesoterodine, Tolterodine ER and placebo, respectively. CONCLUSIONS • In this randomized study, which is the largest to compare antimuscarinic efficacy performed to date, fesoterodine 8 mg was superior to Tolterodine ER 4 mg for UUI episodes, micturitions and urgency episodes, as well as for self-reported patient assessments of bladder-related problems, urgency, symptom bother and health-related quality of life. • The superiority of fesoterodine 8 mg over Tolterodine ER 4 mg was observed as early as 3 weeks after escalation from fesoterodine 4 mg for most outcomes. These data may have important implications for the clinical management of OAB patients previously treated with Tolterodine ER.

  • Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
    European Urology, 2009
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-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) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, Tolterodine ER (4mg), tamsulosin (0.4mg), or Tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( 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 p 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 (≤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.

  • effects of serum psa on efficacy of Tolterodine extended release with or without tamsulosin in men with luts including oab
    Urology, 2008
    Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    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 ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized 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 (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥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 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 (

  • extended release Tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
    BJUI, 2008
    Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong Guan
    Abstract:

    OBJECTIVE To evaluate the efficacy of Tolterodine extended-release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, Tolterodine ER (4 mg), tamsulosin (0.4 mg), or Tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving Tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the Tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the Tolterodine ER + tamsulosin and Tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, Tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.

Claus G Roehrborn - One of the best experts on this subject based on the ideXlab platform.

  • Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
    European Urology, 2009
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-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) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, Tolterodine ER (4mg), tamsulosin (0.4mg), or Tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( 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 p 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 (≤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.

  • effects of serum psa on efficacy of Tolterodine extended release with or without tamsulosin in men with luts including oab
    Urology, 2008
    Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    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 ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized 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 (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥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 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 (

  • extended release Tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
    BJUI, 2008
    Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong Guan
    Abstract:

    OBJECTIVE To evaluate the efficacy of Tolterodine extended-release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, Tolterodine ER (4 mg), tamsulosin (0.4 mg), or Tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving Tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the Tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the Tolterodine ER + tamsulosin and Tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, Tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.

  • Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
    JAMA, 2006
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong Guan
    Abstract:

    ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of Tolterodine extended release (ER), tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of Tolterodine ER (n = 217), 0.4 mg of tamsulosin (n = 215), or both Tolterodine ER plus tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving Tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving tamsulosin (P=.06 vs placebo), or 135 (65%) receiving Tolterodine ER (P=.48 vs placebo). Patients receiving Tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving Tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (Tolterodine ER plus tamsulosin, 0.4%; Tolterodine ER, 0.5%; tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with Tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654

  • efficacy and tolerability of Tolterodine extended release in men with overactive bladder and urgency urinary incontinence
    BJUI, 2006
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Eric S Rovner, Sender Herschorn, Paul Abrams, Zhonghong Guan
    Abstract:

    A group of authors from the USA evaluated the efficacy and tolerability of Tolterodine extended-release on objective and subjective endpoints in men with an overactive bladder. They found that it significantly reduced incontinent episodes and improved patient perception of treatment benefit in men with an overactive bladder OBJECTIVE To evaluate the efficacy and tolerability of Tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of Tolterodine ER (4 mg once daily; Tolterodine ER registration trial) and included men with urinary frequency (≥8 micturitions/24 h) and urgency UI (≥5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study. RESULTS In all, 163 men with OAB (placebo, 86; Tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, Tolterodine ER significantly reduced weekly UI episodes (median % change, −71% vs − 40%, P < 0.05; mean numeric change, − 11.9 vs −5.9, P = 0.02). Men receiving Tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, −12% vs − 4%, P = 0.22). Significantly more men treated with Tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with Tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving Tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization. CONCLUSION In men with OAB and urgency UI, Tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.

Tamara Bavendam - One of the best experts on this subject based on the ideXlab platform.

  • combined effects of behavioral intervention and Tolterodine in patients dissatisfied with overactive bladder medication
    The Journal of Urology, 2009
    Co-Authors: Carl G Klutke, Zhonghong Guan, Kathryn L Burgio, Jean F Wyman, Franklin Sun, Sandra Berriman, Tamara Bavendam
    Abstract:

    Purpose: We assessed the effect of Tolterodine extended release plus behavioral intervention on treatment satisfaction and bladder diary variables in patients with overactive bladder who had been previously treated and were dissatisfied with Tolterodine or other antimuscarinics.Materials and Methods: This 16-week, multicenter, open label study included eligible patients 18 years old or older who reported overactive bladder symptoms 3 months or greater in duration, 8 or greater micturitions and 2 or greater urgency related micturitions per 24 hours, and 1 or greater urgency urinary incontinence episodes in a 5-day bladder diary at baseline as well as dissatisfaction with prior antimuscarinic medication. Patients received Tolterodine extended release plus self-administered behavioral intervention, consisting of an educational pamphlet with verbal reinforcement, for 8 weeks. Satisfied patients continued with this therapy and dissatisfied patients received Tolterodine extended release plus individualized beha...

  • Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms effects of prostate size
    European Urology, 2009
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Stephen J Jones, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    Abstract Background Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an α-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) ≥12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) max ) >5mL/s were randomized to receive placebo, Tolterodine ER (4mg), tamsulosin (0.4mg), or Tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume ( 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 p 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 (≤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.

  • effects of serum psa on efficacy of Tolterodine extended release with or without tamsulosin in men with luts including oab
    Urology, 2008
    Co-Authors: Claus G Roehrborn, Stephen R Kraus, Steven A Kaplan, Joseph T Wang, Tamara Bavendam, Zhonghong Guan
    Abstract:

    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 ≥40 years old with frequency and urgency (with or without urge urinary incontinence), postvoid residual urine volume 5 mL/s, International Prostate Symptom Score (IPSS) of ≥12, and quality-of-life score of ≥3. They had been randomized 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 (≥1.3 vs Results The PSA level correlated significantly with prostate size. Men with a PSA level of ≥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 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 (

  • extended release Tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder effects on urinary symptoms assessed by the international prostate symptom score
    BJUI, 2008
    Co-Authors: Steven A Kaplan, Claus G Roehrborn, Tamara Bavendam, Martin Carlsson, Michael B Chancellor, Zhonghong Guan
    Abstract:

    OBJECTIVE To evaluate the efficacy of Tolterodine extended-release (ER) plus tamsulosin on lower urinary tract symptoms (LUTS) as assessed by changes in the International Prostate Symptom Score (IPSS) in men who met symptom entry criteria for both overactive bladder (OAB) and benign prostatic hyperplasia (BPH) trials. PATIENTS AND METHODS Men aged ≥40 years with an IPSS of ≥12 and diary-documented OAB symptoms (≥8 voids/24 h and ≥3 urgency episodes/24 h, with or without urgency urinary incontinence) who reported at least moderate problems related to their bladder condition were randomized to receive placebo, Tolterodine ER (4 mg), tamsulosin (0.4 mg), or Tolterodine ER (4 mg) + tamsulosin (0.4 mg) once daily for 12 weeks. Patients completed the IPSS at baseline and at 1, 6 and 12 weeks. RESULTS Patients receiving Tolterodine ER + tamsulosin had significantly greater improvements than those taking placebo on IPSS storage subscale scores and scores for all three individual storage items included on the IPSS (urinary frequency, urgency, and nocturnal micturitions) by 12 weeks. Storage subscale and urgency scores were significantly improved vs placebo at 1 and 6 weeks, whereas frequency scores were significantly improved at 6 weeks. Changes in IPSS storage subscale and individual storage item scores in the Tolterodine ER and tamsulosin monotherapy groups were not significantly different from placebo at most time points. IPSS voiding subscale scores and scores for three of four individual voiding items (sensation of incomplete emptying, intermittency, and weak stream) were significantly improved by 12 weeks for patients receiving tamsulosin monotherapy vs placebo. Voiding subscale and intermittency scores were significantly improved vs placebo at 1 week; weak stream scores were significantly improved at 1 and 6 weeks. The IPSS voiding subscale and individual voiding item scores in the Tolterodine ER + tamsulosin and Tolterodine ER groups were not significantly different from placebo at most time points. CONCLUSIONS In this distinct clinical research population of men who met traditional symptom entry criteria for both OAB and BPH trials, Tolterodine ER + tamsulosin was significantly more effective than placebo in treating storage LUTS, including OAB symptoms. Tamsulosin monotherapy produced significant improvements in voiding LUTS.

  • Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
    JAMA, 2006
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong Guan
    Abstract:

    ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of Tolterodine extended release (ER), tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of Tolterodine ER (n = 217), 0.4 mg of tamsulosin (n = 215), or both Tolterodine ER plus tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving Tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving tamsulosin (P=.06 vs placebo), or 135 (65%) receiving Tolterodine ER (P=.48 vs placebo). Patients receiving Tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving Tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (Tolterodine ER plus tamsulosin, 0.4%; Tolterodine ER, 0.5%; tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with Tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654

Eric S Rovner - One of the best experts on this subject based on the ideXlab platform.

  • Tolterodine extended release is efficacious in continent and incontinent subjects with overactive bladder.
    Urology, 2008
    Co-Authors: Eric S Rovner, Joseph T Wang, Raymond R. Rackley, Victor W. Nitti, Zhonghong Guan
    Abstract:

    OBJECTIVES To assess efficacy and tolerability of Tolterodine extended release (ER) in continent and incontinent subjects with overactive bladder (OAB). METHODS This was a post hoc analysis of data from a 12-week, double-blind, placebo-controlled trial of Tolterodine ER (4 mg once daily). Subjects completed 7-day bladder diaries at baseline and week 12; those with one or more incontinence episode(s) in their diaries at baseline were considered incontinent. Subjects rated urgency associated with each micturition on a scale from 1 to 5, and micturitions were categorized post hoc by urgency rating as non-OAB (1-2), OAB (3-5), or severe OAB (4-5). RESULTS At baseline, 40% of subjects were incontinent. Tolterodine ER (n = 429) reduced total, OAB, and severe OAB micturitions compared with placebo (n = 421) in continent and incontinent subjects. There was no difference between continent and incontinent subjects in terms of the magnitude of improvement with Tolterodine ER relative to placebo for total, OAB, and severe OAB micturitions. Reductions in mean urgency and frequency-urgency sum ratings were significantly greater in the Tolterodine ER group. Among incontinent subjects, Tolterodine ER significantly reduced urgency urinary incontinence episodes and significantly increased the percentage of subjects achieving continence relative to placebo. Adverse event rates were low in both continent and incontinent subjects. CONCLUSIONS Tolterodine ER reduced micturitions associated with urgency (OAB or severe OAB) in both continent and incontinent subjects. Tolterodine ER also reduced urgency urinary incontinence episodes in incontinent subjects. These data show that Tolterodine ER is effective and well tolerated in both continent and incontinent subjects with OAB.

  • Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder a randomized controlled trial
    JAMA, 2006
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Tamara Bavendam, Eric S Rovner, Martin Carlsson, Zhonghong Guan
    Abstract:

    ContextMen with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or α-receptor antagonists.ObjectiveTo evaluate the efficacy and safety of Tolterodine extended release (ER), tamsulosin, or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia.Design, Setting, and ParticipantsRandomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (≥8 micturitions per 24 hours) and urgency (≥3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006.InterventionsPatients were randomly assigned to receive placebo (n = 222), 4 mg of Tolterodine ER (n = 217), 0.4 mg of tamsulosin (n = 215), or both Tolterodine ER plus tamsulosin (n = 225) for 12 weeks.Main Outcome MeasuresPatient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed.ResultsA total of 172 men (80%) receiving Tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving tamsulosin (P=.06 vs placebo), or 135 (65%) receiving Tolterodine ER (P=.48 vs placebo). Patients receiving Tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (−0.88 vs −0.31, P=.005), urgency episodes without incontinence (−3.33 vs −2.54, P=.03), micturitions per 24 hours (−2.54 vs −1.41, P<.001), and micturitions per night (−0.59 vs −0.39, P.02). Patients receiving Tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (−8.02 vs placebo, −6.19, P=.003) and QOL item (−1.61 vs −1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low (Tolterodine ER plus tamsulosin, 0.4%; Tolterodine ER, 0.5%; tamsulosin, 0%; and placebo, 0%).ConclusionsThese results suggest that treatment with Tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder.Clinical Trials Registrationclinicaltrials.gov Identifier: NCT00147654

  • efficacy and tolerability of Tolterodine extended release in men with overactive bladder and urgency urinary incontinence
    BJUI, 2006
    Co-Authors: Claus G Roehrborn, Steven A Kaplan, Eric S Rovner, Sender Herschorn, Paul Abrams, Zhonghong Guan
    Abstract:

    A group of authors from the USA evaluated the efficacy and tolerability of Tolterodine extended-release on objective and subjective endpoints in men with an overactive bladder. They found that it significantly reduced incontinent episodes and improved patient perception of treatment benefit in men with an overactive bladder OBJECTIVE To evaluate the efficacy and tolerability of Tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of Tolterodine ER (4 mg once daily; Tolterodine ER registration trial) and included men with urinary frequency (≥8 micturitions/24 h) and urgency UI (≥5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study. RESULTS In all, 163 men with OAB (placebo, 86; Tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, Tolterodine ER significantly reduced weekly UI episodes (median % change, −71% vs − 40%, P < 0.05; mean numeric change, − 11.9 vs −5.9, P = 0.02). Men receiving Tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, −12% vs − 4%, P = 0.22). Significantly more men treated with Tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with Tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving Tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization. CONCLUSION In men with OAB and urgency UI, Tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.

  • Tolterodine for the treatment of overactive bladder: a review.
    Expert opinion on pharmacotherapy, 2005
    Co-Authors: Eric S Rovner
    Abstract:

    Overactive bladder (OAB) is a prevalent condition. Numerous clinical trials have demonstrated the efficacy and safety of immediate release Tolterodine in the treatment of OAB in different patient populations. This review details the characteristics, clinical efficacy and safety of extended release (ER) Tolterodine. This formulation yields a flatter serum concentration profile and provides clinically meaningful symptom improvement as early as week 1 of treatment. Tolterodine ER is effective in diverse patient populations with varying levels of symptom severity, and efficacy is maintained with long-term treatment. Tolterodine is an effective, safe, and convenient treatment option for long-term relief of OAB symptoms.

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