The Experts below are selected from a list of 1047 Experts worldwide ranked by ideXlab platform
David R Staskin - One of the best experts on this subject based on the ideXlab platform.
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Trospium Chloride once daily extended release is efficacious and tolerated in elderly subjects aged 75 years with overactive bladder syndrome
BJUI, 2011Co-Authors: Peter K Sand, Eric S Rovner, Michael G. Oefelein, Theodore M Johnson, Pamela Ellsworth, David R StaskinAbstract:Study Type – Therapy (data synthesis from RCTs) Level of Evidence 1c What’s known on the subject? and What does the study add? Treatment of overactive bladder syndrome (OAB) in elderly individuals presents several potential clinical challenges, which include alterations in sleep and cognition, multiple co-morbidities, polypharmacy, and frailty syndrome. A broad consensus of clinical opinion exists that the addition of an overactive bladder medication may amplify these clinical challenges via the antimuscarinic effects on cognition and the potential for drug-drug interactions. The quaternary amine structure of Trospium Chloride provides protection against penetration of the blood-brain barrier, and minimizes the potential for metabolic drug-drug interactions. This study globally supports the efficacy and safety of Sanctura XR (extended release Trospium Chloride) in a population of elderly patients (75 years or older) with overactive bladder syndrome and multiple co-morbidities at risk for drug-drug interactions, impaired cognition and frailty syndrome. OBJECTIVE • To evaluate the safety and efficacy of once-daily Trospium Chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥75 years. SUBJECTS AND METHODS • The analysis included subjects ≥75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily Trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received Trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥75 years (85 Trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS • At week 12 of the double-blind period, Trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label Trospium ER for up to 1 year. CONCLUSIONS • Once-daily Trospium Chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.
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Trospium Chloride Once-Daily Extended Release Is Efficacious and Tolerated in Elderly Subjects (Aged ≥ 75 Years) With Overactive Bladder Syndrome
BJUI, 2010Co-Authors: Peter K Sand, Eric S Rovner, Michael G. Oefelein, Theodore M Johnson, Pamela Ellsworth, David R StaskinAbstract:Study Type – Therapy (data synthesis from RCTs) Level of Evidence 1c What’s known on the subject? and What does the study add? Treatment of overactive bladder syndrome (OAB) in elderly individuals presents several potential clinical challenges, which include alterations in sleep and cognition, multiple co-morbidities, polypharmacy, and frailty syndrome. A broad consensus of clinical opinion exists that the addition of an overactive bladder medication may amplify these clinical challenges via the antimuscarinic effects on cognition and the potential for drug-drug interactions. The quaternary amine structure of Trospium Chloride provides protection against penetration of the blood-brain barrier, and minimizes the potential for metabolic drug-drug interactions. This study globally supports the efficacy and safety of Sanctura XR (extended release Trospium Chloride) in a population of elderly patients (75 years or older) with overactive bladder syndrome and multiple co-morbidities at risk for drug-drug interactions, impaired cognition and frailty syndrome. OBJECTIVE • To evaluate the safety and efficacy of once-daily Trospium Chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥75 years. SUBJECTS AND METHODS • The analysis included subjects ≥75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily Trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received Trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥75 years (85 Trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS • At week 12 of the double-blind period, Trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label Trospium ER for up to 1 year. CONCLUSIONS • Once-daily Trospium Chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.
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Trospium Chloride has no effect on memory testing and is assay undetectable in the central nervous system of older patients with overactive bladder
International Journal of Clinical Practice, 2010Co-Authors: David R Staskin, Cara Tannenbaum, Howard B Goldman, K Bhashi, Michael G. OefeleinAbstract:Summary Background: Muscarinic receptors in the brain play an important role in cognitive function, especially memory, and there is growing awareness that specific antimuscarinic drugs for overactive bladder (OAB) may have adverse central nervous system (CNS) effects. Selection of an antimuscarinic OAB drug with reduced potential for CNS effects could be especially beneficial in the elderly people, in whom even the modest cognitive impairment may negatively affect independence. Purpose: The purpose of the study is to determine if Trospium Chloride is assay detectable in the CNS of older adults with OAB and to assess whether deterioration of memory occurs in these individuals. Methods: Twelve cognitively intact older adults (≥65–75 years old) with OAB were given extended-release Trospium Chloride 60 mg once daily over a 10-day period to achieve plasma steady-state levels. Standardised memory testing (Hopkins Verbal Learning Test-Revised and Brief Visuospatial Memory Test-Revised) was performed predose and postdose. Cerebrospinal spinal fluid (CSF) and plasma samples were drawn on day 10 and assayed for Trospium Chloride. Predose (day 0) and postdose (day 10) results on the memory tests were compared using a reliable change index to assess a meaningful change in learning or memory. Results: Trospium Chloride levels in all the CSF samples (n = 72) of all participants were assay undetectable (<40 pg/ml) on day 10 at steady-state peak plasma concentration concurrent with measureable peak plasma values (Cmax = 925 pg/ml). Repeat memory testing revealed no significant net drug effect on learning or recall. Conclusions: This is the first study to investigate for the presence of an OAB antimuscarinic in the human brain, performed by assaying for concentrations of Trospium Chloride and correlating with simultaneous clinical cognitive safety measures. The results of both pharmacological and neuropsychological testing support the hypothesis of a lack of detectable CNS penetration for the quaternary amine Trospium Chloride.
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Trospium Chloride has no effect on memory testing and is assay undetectable in the central nervous system of older patients with overactive bladder.
International Journal of Clinical Practice, 2010Co-Authors: David R Staskin, Cara Tannenbaum, Howard B Goldman, K Bhashi, Michael G. OefeleinAbstract:Summary Background: Muscarinic receptors in the brain play an important role in cognitive function, especially memory, and there is growing awareness that specific antimuscarinic drugs for overactive bladder (OAB) may have adverse central nervous system (CNS) effects. Selection of an antimuscarinic OAB drug with reduced potential for CNS effects could be especially beneficial in the elderly people, in whom even the modest cognitive impairment may negatively affect independence. Purpose: The purpose of the study is to determine if Trospium Chloride is assay detectable in the CNS of older adults with OAB and to assess whether deterioration of memory occurs in these individuals. Methods: Twelve cognitively intact older adults (≥65–75 years old) with OAB were given extended-release Trospium Chloride 60 mg once daily over a 10-day period to achieve plasma steady-state levels. Standardised memory testing (Hopkins Verbal Learning Test-Revised and Brief Visuospatial Memory Test-Revised) was performed predose and postdose. Cerebrospinal spinal fluid (CSF) and plasma samples were drawn on day 10 and assayed for Trospium Chloride. Predose (day 0) and postdose (day 10) results on the memory tests were compared using a reliable change index to assess a meaningful change in learning or memory. Results: Trospium Chloride levels in all the CSF samples (n = 72) of all participants were assay undetectable (
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extended release Trospium Chloride improves quality of life in overactive bladder
Value in Health, 2010Co-Authors: Roger R Dmochowski, Norman Zinner, David R Staskin, Matt T Rosenberg, Peter K SandAbstract:ABSTRACT Objectives Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine Trospium Chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with Trospium Chloride ER 60 mg were analyzed. Methods Subjects aged ≥18 years with urinary urgency, frequency, and an average of ≥1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily Trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q). Results Overall, 1165 subjects were randomized (Trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with Trospium ER than with placebo (+25.8 vs. +20.7; P = 0.0003). Improvements from baseline were seen with Trospium ER on all eight of the OAB-q symptom bother scales. Conclusions Once-daily Trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.
Peter K Sand - One of the best experts on this subject based on the ideXlab platform.
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Trospium Chloride once daily extended release is efficacious and tolerated in elderly subjects aged 75 years with overactive bladder syndrome
BJUI, 2011Co-Authors: Peter K Sand, Eric S Rovner, Michael G. Oefelein, Theodore M Johnson, Pamela Ellsworth, David R StaskinAbstract:Study Type – Therapy (data synthesis from RCTs) Level of Evidence 1c What’s known on the subject? and What does the study add? Treatment of overactive bladder syndrome (OAB) in elderly individuals presents several potential clinical challenges, which include alterations in sleep and cognition, multiple co-morbidities, polypharmacy, and frailty syndrome. A broad consensus of clinical opinion exists that the addition of an overactive bladder medication may amplify these clinical challenges via the antimuscarinic effects on cognition and the potential for drug-drug interactions. The quaternary amine structure of Trospium Chloride provides protection against penetration of the blood-brain barrier, and minimizes the potential for metabolic drug-drug interactions. This study globally supports the efficacy and safety of Sanctura XR (extended release Trospium Chloride) in a population of elderly patients (75 years or older) with overactive bladder syndrome and multiple co-morbidities at risk for drug-drug interactions, impaired cognition and frailty syndrome. OBJECTIVE • To evaluate the safety and efficacy of once-daily Trospium Chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥75 years. SUBJECTS AND METHODS • The analysis included subjects ≥75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily Trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received Trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥75 years (85 Trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS • At week 12 of the double-blind period, Trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label Trospium ER for up to 1 year. CONCLUSIONS • Once-daily Trospium Chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.
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Trospium Chloride Once-Daily Extended Release Is Efficacious and Tolerated in Elderly Subjects (Aged ≥ 75 Years) With Overactive Bladder Syndrome
BJUI, 2010Co-Authors: Peter K Sand, Eric S Rovner, Michael G. Oefelein, Theodore M Johnson, Pamela Ellsworth, David R StaskinAbstract:Study Type – Therapy (data synthesis from RCTs) Level of Evidence 1c What’s known on the subject? and What does the study add? Treatment of overactive bladder syndrome (OAB) in elderly individuals presents several potential clinical challenges, which include alterations in sleep and cognition, multiple co-morbidities, polypharmacy, and frailty syndrome. A broad consensus of clinical opinion exists that the addition of an overactive bladder medication may amplify these clinical challenges via the antimuscarinic effects on cognition and the potential for drug-drug interactions. The quaternary amine structure of Trospium Chloride provides protection against penetration of the blood-brain barrier, and minimizes the potential for metabolic drug-drug interactions. This study globally supports the efficacy and safety of Sanctura XR (extended release Trospium Chloride) in a population of elderly patients (75 years or older) with overactive bladder syndrome and multiple co-morbidities at risk for drug-drug interactions, impaired cognition and frailty syndrome. OBJECTIVE • To evaluate the safety and efficacy of once-daily Trospium Chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥75 years. SUBJECTS AND METHODS • The analysis included subjects ≥75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily Trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received Trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥75 years (85 Trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS • At week 12 of the double-blind period, Trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label Trospium ER for up to 1 year. CONCLUSIONS • Once-daily Trospium Chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.
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extended release Trospium Chloride improves quality of life in overactive bladder
Value in Health, 2010Co-Authors: Roger R Dmochowski, Norman Zinner, David R Staskin, Matt T Rosenberg, Peter K SandAbstract:ABSTRACT Objectives Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine Trospium Chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with Trospium Chloride ER 60 mg were analyzed. Methods Subjects aged ≥18 years with urinary urgency, frequency, and an average of ≥1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily Trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q). Results Overall, 1165 subjects were randomized (Trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with Trospium ER than with placebo (+25.8 vs. +20.7; P = 0.0003). Improvements from baseline were seen with Trospium ER on all eight of the OAB-q symptom bother scales. Conclusions Once-daily Trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.
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Trospium Chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trials.
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p
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Trospium Chloride once daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome an integrated analysis of two randomised phase iii trials
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p < 0.001) and UUI episodes/day (−1.8 vs. −2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (Trospium XR, 10.7%; placebo, 3.7%) and constipation (Trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with Trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions: Treatment with Trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with Trospium immediate-release, although not compared in a head-to-head study).
Roger R Dmochowski - One of the best experts on this subject based on the ideXlab platform.
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extended release Trospium Chloride improves quality of life in overactive bladder
Value in Health, 2010Co-Authors: Roger R Dmochowski, Norman Zinner, David R Staskin, Matt T Rosenberg, Peter K SandAbstract:ABSTRACT Objectives Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine Trospium Chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with Trospium Chloride ER 60 mg were analyzed. Methods Subjects aged ≥18 years with urinary urgency, frequency, and an average of ≥1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily Trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q). Results Overall, 1165 subjects were randomized (Trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with Trospium ER than with placebo (+25.8 vs. +20.7; P = 0.0003). Improvements from baseline were seen with Trospium ER on all eight of the OAB-q symptom bother scales. Conclusions Once-daily Trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.
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Trospium Chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trials.
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p
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Trospium Chloride once daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome an integrated analysis of two randomised phase iii trials
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p < 0.001) and UUI episodes/day (−1.8 vs. −2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (Trospium XR, 10.7%; placebo, 3.7%) and constipation (Trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with Trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions: Treatment with Trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with Trospium immediate-release, although not compared in a head-to-head study).
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Trospium Chloride extended release is effective and well tolerated in women with overactive bladder syndrome
International Urogynecology Journal, 2009Co-Authors: Peter K Sand, Roger R Dmochowski, Norman Zinner, David R Staskin, Rodney A AppellAbstract:Introduction and hypothesis To confirm the efficacy and tolerability of extended release (ER) Trospium Chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.
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once daily Trospium Chloride is effective and well tolerated for the treatment of overactive bladder results from a multicenter phase iii trial
The Journal of Urology, 2007Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Roger R DmochowskiAbstract:Purpose: An extended release formulation of Trospium Chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg Trospium Chloride once daily.Materials and Methods: Subjects with overactive bladder were randomized 1:1 to receive 60 mg Trospium Chloride once daily or placebo in this 12-week multicenter, parallel, double-blind, placebo controlled trial. Primary end points were calculated changes in diary recorded daily urinary frequency and daily urgency urinary incontinence episodes. Secondary end points were urgency severity, volume voided per void and the number of urgency voids per day. Safety was assessed by clinical examination, adverse event monitoring, clinical laboratory values and resting electrocardiograms.Results: Overall 601 subjects were prescribed Trospium once daily (298) or placebo (303). Trospium once daily treatment resulted in significant improvements over placebo in all primary and key secondary effic...
Mohamed E. Hassouna - One of the best experts on this subject based on the ideXlab platform.
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transcutaneous posterior tibial nerve electrostimulation with low dose Trospium Chloride could it be used as a second line treatment of overactive bladder in females
Neurourology and Urodynamics, 2018Co-Authors: Amr Abulseoud, Ahmed Moussa, Gaber Abdelfattah, Ibrahim Khalil Ibrahim, Emmanuel Kamal Aziz Saba, Mohamed E. HassounaAbstract:Aim To evaluate the effect of adding low dose Trospium Chloride with transcutaneous posterior tibial nerve stimulation (TPTNS) in the treatment of overactive bladder (OAB) in females after failure of behavioral therapy. Methods We randomized 30 women with OAB, in two groups: G I received 30 min TPTNS, three times a week; GII received TPTNS plus 20 mg Trospium Chloride daily. OAB Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8 were evaluated. Results The groups were similar before treatment. Eight weeks after treatment, the mean OABSS decreased significantly to 8.53 ± 1.30 for group II vs 10.0 ± 2.0 for GI (P < 0.024). The mean IIQ-7 score decreased significantly to 51.86 ± 17.26 in group I vs 31.99 ± 9.26 in group II (P < 0.001). Before treatment, 11 (73.3%) and 4 (26.7%) patients in each group had moderate and poor quality of life (QoL), respectively. After treatment, 6 (40%) and 14 (93.3%) had good QoL, 7 (46.7%) and 1 (6.7%) had moderate QoL in GI and GII, respectively. Two (13.3%) patients in GI had poor QoL. The mean frequency was reduced to 8.60 ± 0.83 vs 10.60 ± 2.32 for GII and GI respectively (P = 0.006). The cystometric capacity increased from 263.40 ± 50.45 to 377.80 ± 112.92 mL (P = 0.001) for GII vs 250.13 ± 56.24 to 296.40 ± 99.0 mL (P = 0.026) for GI. Conclusion TPTNS combined with low dose Trospium Chloride proved to be more effective than TPTNS alone in the treatment of OAB in females.
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Transcutaneous posterior tibial nerve electrostimulation with low dose Trospium Chloride: Could it be used as a second line treatment of overactive bladder in females.
Neurourology and Urodynamics, 2017Co-Authors: Amr Abulseoud, Ahmed Moussa, Gaber Abdelfattah, Ibrahim Khalil Ibrahim, Emmanuel Kamal Aziz Saba, Mohamed E. HassounaAbstract:Aim To evaluate the effect of adding low dose Trospium Chloride with transcutaneous posterior tibial nerve stimulation (TPTNS) in the treatment of overactive bladder (OAB) in females after failure of behavioral therapy. Methods We randomized 30 women with OAB, in two groups: G I received 30 min TPTNS, three times a week; GII received TPTNS plus 20 mg Trospium Chloride daily. OAB Symptom Score questionnaire (OABSS), Incontinence Impact Questionnaire-short form 7 (IIQ-7), 3 day voiding diary and urodynamics at weeks 0 and 8 were evaluated. Results The groups were similar before treatment. Eight weeks after treatment, the mean OABSS decreased significantly to 8.53 ± 1.30 for group II vs 10.0 ± 2.0 for GI (P
Norman Zinner - One of the best experts on this subject based on the ideXlab platform.
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Trospium Chloride improves overactive bladder symptoms: a multicenter phase III trial.
The Journal of urology, 2020Co-Authors: Norman Zinner, Richard Harris, Marc Gittelman, Jacques Susset, Angelo Kanelos, Stephen AuerbachAbstract:Trospium Chloride is an anticholinergic agent with predominantly peripheral nonselective antimuscarinic activity lacking central nervous system effects. It has no known drug-drug interactions, an advantage for patients taking many medications. Because these qualities may provide added benefit when treating patients with symptoms associated with overactive bladder (OAB) and urge incontinence, we studied the effectiveness of Trospium in treating these conditions. Patients with OAB with urge incontinence were randomized 1:1 to 20 mg Trospium twice daily or placebo in this 12-week, multicenter, parallel, double-blind, placebo controlled trial. Dual primary end points were change in average number of toilet voids and change in urge incontinent episodes per 24 hours. Secondary efficacy variables were change in average of volume per void, voiding urge severity, urinations during day and night, time to onset of action and change in Incontinence Impact Questionnaire. A total of 523 patients were entered at 51 sites. Trospium significantly decreased average frequency of toilet voids and urge incontinent episodes compared to placebo. It significantly increased average volume per void, and decreased average urge severity and daytime frequency. All effects occurred by week 1 and all were sustained throughout the study. Nocturnal frequency decreased significantly by week 4 and Incontinence Impact Questionnaire scores improved at week 12. Trospium was well tolerated. Trospium was found to have sustained effectiveness beginning at the end of week 1 in decreasing the number of voids, urge incontinent episodes, total daily micturitions and urge severity, and in increasing volume per void. It also improved symptoms of OAB and quality of life.
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extended release Trospium Chloride improves quality of life in overactive bladder
Value in Health, 2010Co-Authors: Roger R Dmochowski, Norman Zinner, David R Staskin, Matt T Rosenberg, Peter K SandAbstract:ABSTRACT Objectives Overactive bladder syndrome (OAB) is a urinary condition that often exerts detrimental effects on an individual's quality of life (QoL). A once-daily, extended-release (ER) formulation of the quaternary amine Trospium Chloride has recently been developed for the treatment of OAB. The pooled health-related QoL (HRQoL) data from two multicenter, parallel-group, double-blind Phase III studies with Trospium Chloride ER 60 mg were analyzed. Methods Subjects aged ≥18 years with urinary urgency, frequency, and an average of ≥1 urge urinary incontinence episode per day on a 3-day bladder diary were randomized (1:1) to receive once-daily Trospium 60 mg ER or placebo for 12 weeks. HRQoL was assessed at baseline and at Week 12 using the King's Health Questionnaire (KHQ) and the OAB questionnaire (OAB-q). Results Overall, 1165 subjects were randomized (Trospium ER, n=578; placebo, n=587). Trospium ER produced significantly greater improvements from baseline than placebo in seven of the nine KHQ domains. At Week 12, the improvement in mean OAB-q HRQoL total score (from approximately 52 at baseline) was significantly greater with Trospium ER than with placebo (+25.8 vs. +20.7; P = 0.0003). Improvements from baseline were seen with Trospium ER on all eight of the OAB-q symptom bother scales. Conclusions Once-daily Trospium 60 mg ER improved the QoL of subjects with OAB, as assessed using the KHQ and the OAB-q, in two large Phase III clinical trials.
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Trospium Chloride once-daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome: an integrated analysis of two randomised, phase III trials.
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p
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Trospium Chloride once daily extended release is effective and well tolerated for the treatment of overactive bladder syndrome an integrated analysis of two randomised phase iii trials
International Journal of Clinical Practice, 2009Co-Authors: David R Staskin, Norman Zinner, Peter K Sand, Matt T Rosenberg, Roger R DmochowskiAbstract:Summary Background: Trospium Chloride is an antimuscarinic agent with a hydrophilic polar quaternary amine structure that is minimally metabolised by hepatic cytochrome P450 and is actively excreted in the urine, each of which confers a potential benefit with regard to efficacy and tolerability. Purpose: We analysed pooled data from two identically designed phase III trials of a once-daily, extended-release (XR) formulation of Trospium Chloride (Trospium XR 60-mg capsules) in subjects with overactive bladder syndrome (OAB). Methods: Adults with OAB of ≥ 6 months’ duration with urinary urgency, frequency and ≥ 1 urge urinary incontinence (UUI) episode/day were enrolled in these multicentre, parallel-group, double-blind trials. Participants were randomised (1 : 1) to receive Trospium XR 60 mg or placebo for 12 weeks. Primary efficacy variables were changes in urinary frequency and the number of UUI episodes/day. Adverse events (AEs) were recorded throughout. Results: In total, 1165 subjects were randomised (Trospium XR, 578; placebo, 587). At baseline, subjects averaged 12.8 toilet voids/day and 4.1 UUI episodes/day. Compared with placebo, subjects treated with Trospium XR had significantly greater reductions from baseline in the mean number of toilet voids/day (−1.9 vs. −2.7; p < 0.001) and UUI episodes/day (−1.8 vs. −2.4; p < 0.001) at week 12. The most frequent AEs considered possibly related to study treatment were dry mouth (Trospium XR, 10.7%; placebo, 3.7%) and constipation (Trospium XR, 8.5%; placebo, 1.5%). Notably, rates of central nervous system (CNS) AEs were lower with Trospium XR vs. placebo (dizziness: 0.2% vs. 1.0%; headache: 1.4% vs. 2.4%). Conclusions: Treatment with Trospium XR resulted in statistically significant improvements in both of the dual primary and all of the secondary outcome variables. Trospium XR demonstrated favourable rates of AEs, particularly CNS AEs (numerically lower than with placebo) and dry mouth (lower than previously reported with Trospium immediate-release, although not compared in a head-to-head study).
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Trospium Chloride extended release is effective and well tolerated in women with overactive bladder syndrome
International Urogynecology Journal, 2009Co-Authors: Peter K Sand, Roger R Dmochowski, Norman Zinner, David R Staskin, Rodney A AppellAbstract:Introduction and hypothesis To confirm the efficacy and tolerability of extended release (ER) Trospium Chloride in women with overactive bladder syndrome (OAB), data from two identical phase III studies were analyzed.