翁沥通联合托特罗定治疗女性膀胱过度活动症的疗效性和安全性研究

目的评估翁沥通联合托特罗定治疗女性膀胱过度活动症(OAB)的疗效和安全性。方法该研究针对156例OAB女性患者进行前瞻性、随机、多中心临床试验,最后123例患者(单用翁沥通组41例、单用托特罗定组39例、翁沥通联合托特罗定组43例)完成了为期8周的治疗。以膀胱过度活动症症状评分(OABSS),24h排尿日记中每日平均排尿次数、平均排尿量和急迫性尿失禁症状作为主要疗效观察指标。结果所有组的OABSS评分、24h排尿日记中每日平均排尿次数、平均排尿量和急迫性尿失禁症状均有显著改善。相比于托特罗定,翁沥通对OABSS(P=0.012)、每日排尿次数(P=0.006)和平均排尿量(P=0.009)的改善较弱。而联合组在这三项中的改善则明显优于其他两组(P0.05)。三组患者生活质量评分变化无显著性差异。安全性方面,只有托特罗定组出现了残余尿量的明显增加(P=0.004)。相比于托特罗定组,翁沥通组口干(P=0.002)和尿液变细(P=0.002)的发生率更低,且残余尿更少(P0.001)。结论翁沥通联合托特罗定治疗女性OAB能发挥协同作用,临床疗效优于单用翁沥通或托特罗定,安全性更好,使OAB女性患者获益更多。     

酒石酸托特罗定治疗膀胱过度活动症的疗效观察

目的观察酒石酸托特罗定治疗膀胱过度活动症(OAB)的疗效和不良反应。方法对128例符合诊断标准的OAB患者口服酒石酸托特罗定片,2 mg/次,2次/d,疗程4周,治疗前后分别行OAB症状评分(OABSS),观察患者日间排尿次数、夜尿次数、平均24 h尿急次数、平均尿失禁次数的变化和不良反应情况。结果治愈80例(62.5%),显效37例(28.9%),无效11例(8.6%)。用药后日间排尿次数、夜尿次数、平均24 h尿急次数、平均尿失禁次数及OABSS总评分较用药前均明显减少,用药前后比较差异有统计学意义。发生不良反应18例(14%),均为轻度口干、眼干、便秘等,无严重不良反应。结论酒石酸托特罗定能有效减轻OAB患者尿急、尿频、夜尿、尿失禁等症状,疗效确切,不良反应发生率低,安全有效。     

酒石酸托特罗定联合经皮胫神经电刺激治疗女性膀胱过度活动症的疗效

目的观察酒石酸托特罗定联合经皮胫神经电刺激对女性膀胱过度活动症的临床疗效。方法选取2013年4月到2015年7月我院收治的女性膀胱过度活动症患者142例,使用数字法随机分为酒石酸托特罗定对照组和酒石酸托特罗定联合经皮胫神经电刺激观察组,每组71例。记录治疗前后的膀胱过度活动症症状评分表(OABSS)评分、平均24h排尿次数、平均24h尿急次数、平均夜尿次数、平均24h尿失禁次数。比较两组临床疗效不良反应发生率。结果治疗后观察组与对照组OABSS评分分别为(5.7±1.1)分和(7.2±1.3)分、平均24h排尿次数分别为(8.1±1.2)次和(9.2±1.8)次、平均24h尿急次数分别为(1.2±0.4)次和(1.9±0.5)次、平均夜尿次数分别为(1.1±0.3)次和(1.6±0.4)次、平均24h尿失禁次数分别为(1.8±0.5)次和(2.4±0.6)次,差异均具有显著性统计学意义(P0.05)。观察组临床治疗有效率为87.3%(62/71),显著高于对照组的71.8%(51/71)(P0.05)。临床不良反应发生率观察组为8.5%(6/71),对照组为7.0%(5/71),两组间差异无统计学意义(P0.05)。结论托特罗定联合经皮胫神经电刺激对女性膀胱过度活动症临床疗效显著,使用安全,值得推广应用。     

米拉贝隆与托特罗定治疗膀胱过度活动症的Meta分析

目的评价米拉贝隆与托特罗定治疗膀胱过度活动症的有效性和安全性。方法通过检索Pubmed、Cochrane Library、Embase数据库中关于米拉贝隆与托特罗定治疗膀胱过度活动症的随机对照试验。根据纳入和排除标准选择文献并进行偏倚风险评价和数据提取,采用Revman5.3软件进行Meta分析。结果本研究共纳入5项随机对照试验,共用4 350例膀胱过度活动症患者。Meta分析结果显示,主要有效性指标:24h平均尿失禁次数(MD=-0.14,95%CI=-0.27～0.00,P=0.04)、24h平均排尿次数(MD=-0.35,95%CI=-0.54～-0.16,P=0.000 3)、每晚平均夜尿次数(MD=-0.04,95%CI=-0.11～0.03,P=0.28);次要有效性指标:每次排尿的尿量(MD=-1.61,95%CI=-4.12～0.91,P=0.21)、24h平均尿急次数(MD=-0.01,95%CI=-0.19～0.17,P=0.93)均表明米拉贝隆疗效与托特罗定相当;两组患者在不良事件的发生率差异无统计学意义(OR=0.76,95%CI=0.57～1.03,P=0.07),但在口干方面米拉贝隆明显优于托特罗定(OR=0.31,95%CI=0.23～0.41,P0.000 01)。结论米拉贝隆对膀胱过度活动症的整体疗效并不逊色于托特罗定。此外,米拉贝隆引起口干的发生率更低,同时不增加高血压的风险,安全性较高。因此,米拉贝隆很有可能成为治疗膀胱过度活动症的一种安全而有效的新选择。     

生物反馈电刺激联合托特罗定治疗膀胱过度活动症合并轻度认知障碍:前瞻性随机对照研究

目的探讨生物反馈电刺激联合托特罗定治疗膀胱过度活动症(overactive bladder,OAB)合并轻度认知障碍(mild cognitive impairment,MCI)的效果。方法选择2017年5月～2018年4月55例OAB合并MCI患者,随机分为联合治疗组27例(口服酒石酸托特罗定缓释片及生物反馈电刺激治疗)和托特罗定组28例(口服酒石酸托特罗定缓释片),4周后比较治疗前后及治疗后2组间膀胱过度活动症症状评分(Overactive Bladder Symptom Score,OABSS)、膀胱过度活动症问卷(Overactive Bladder Questionnaire,OAB-q)、排尿日记、尿动力检查指标,评价2组治疗效果。结果 2组治疗后OABSS及OAB-q得分均明显低于治疗前(P 0. 05),联合治疗组治疗后的OABSS、OAB-q得分分别为(5. 4±3. 3)分、(45. 4±4. 1)分,明显低于托特罗定组治疗后的(7. 6±3. 5)分、(49. 1±3. 3)分(P 0. 05)。2组治疗后白天平均排尿次数、平均夜尿次数、每日平均尿急次数、每日平均急迫性尿失禁次数、每次平均排尿量均有显著改善(P 0. 05),联合治疗组的白天平均排尿次数、每日平均尿急次数、每次平均排尿量分别为(6. 1±1. 6)次、(1. 1±1. 0)次、(239. 1±14. 3) ml,明显优于托特罗定组的(7. 5±1. 8)次、(1. 7±1. 1)次、(202. 4±13. 1) ml (P 0. 05)。联合治疗组治疗后的初始尿意容量、最大膀胱测量容量分别为(153. 1±33. 4) ml、(274. 1±42. 0) ml,明显优于托特罗定组的(133. 0±36. 2) ml、(243. 4±47. 7) ml(P 0. 05)。结论生物反馈电刺激联合托特罗定可以有效地改善OAB合并MCI患者的排尿功能障碍症状,提高生活质量。     

索利那新在托特罗定治疗失败的女性膀胱过度活动症中的应用效果

目的 探讨索利那新对托特罗定治疗失败的女性膀胱过度活动症的临床疗效及安全性. 方法 2010年l -10月收治女性膀胱过度活动症患者48例,经托特罗定治疗失败后,改用索利那新,服药方法为5 mg/次,1次/d,治疗时间为4周.以24 h排尿次数、尿急次数、急迫性尿失禁次数、尿垫使用数量和夜尿次数以及膀胱状态感知度改善作为疗效判定指标,以观察治疗效果. 结果 服药4周后,24h排尿次数由治疗前的(8.7±1.5)次降至(7.2±2.5)次,24 h尿急次数由治疗前(3.4±2.1)次降至(2.0±1.8)次,24 h急迫性尿失禁次数由(2.4±1.8)次降至(1.5±1.2)次,夜尿次数由(2.1±1.8)次降至(1.2±0.8)次,24h尿垫使用数量由(2.2±1.6)片降至(1.4±0.8)片,治疗前后比较差异均有统计学意义(P＜0.05).膀胱状态感知度改善者42例.1例因服药后发生头痛退出,2例因口干和便秘退出,余45例未发生严重不良反应. 结论 索利那新对托特罗定治疗失败的女性膀胱过度活动症的治疗安全有效.     

骶神经电刺激与托特罗定联合治疗继发性女性膀胱过度活动症的临床研究

目的 研究骶神经电刺激与托特罗定联合治疗女性继发性膀胱过度活动症(SOAB)的疗效.方法 收集2006年8月～2012年8月确诊为SOAB的女性患者200例,随机分为两组,每组100例,每组又按尿频尿急、急迫性尿失禁和两种情况兼有分成三个Sub-group.治疗组采用经皮穿刺电刺激骶神经联合托特罗定2mg口服1次/日,对照组仅予托特罗定2mg口服1次/日,疗程为3个月,观察两组间的排尿日记及尿动力学参数,并通过治疗前后抑郁与焦虑的心理评分来分析各组患者的生活质量有无改善.结果 托特罗定虽然对这sub-group三组患者的尿次数、平均尿量和单次排尿量都有所改善,但是差异没有统计学上的意义;但是经过骶神经电刺激加托特罗定的治疗后,患者的尿次数、平均尿量和单次排尿量都比治疗前明显改善,差异有统计学上的意义(p＜0.01).尤其是经过骶神经电刺激联合托特罗定治疗后的尿次数、平均尿量和单次排尿量都比托特罗定治疗后的有改善.同时首次排尿感觉容量(FDV)、最大膀胱压容量(MCBC)、最大尿流率(Qmax)情况,患者均有排尿次数减少,日平均尿量和最大排尿量明显增加的表现.3个月临床症状和尿动力学参数比较差异均有显著意义(P＜0.01).结果还显示不仅两组治疗后的SDS和SAS均比治疗前明显减低(P＜0.01),而且骶神经电刺激联合托特罗定可明显改进患者的生活质量,有统计学差异.结论 骶神经电刺激联合托特罗定治疗可改善女性SOAB患者的排尿功能障碍,改善由女性膀胱过度活动症引起的忧郁和焦虑征从而改善患者的生活质量,疗效优于单用托特罗定,有一定临床意义.     

联合应用托特罗定与多沙唑嗪治疗TURP术后膀胱过度活动症的临床疗效分析

目的 分析联合应用托特罗定与多沙唑嗪治疗TURP术后膀胱过度活动症的临床疗效.方法 80例行TURP的前列腺增生患者按就诊顺序随机分为4组,每组20例,自手术当日起分别单纯给予口服托特罗定、多沙唑嗪、安慰剂及托特罗定联合多沙唑嗪直至拔除导尿管后1周.于拔除尿管后第1天,第7天检测各组最大尿流率(Qmax),并通过调查问卷的形式,记录各组IPSS储尿期分数,以及各组平均每天发生的尿急次数,24小时排尿次数,夜尿次数及用药后不良反应.结果 拔除导尿管后第1天、第7天各组平均Qmax无显著性差异(P>0.05);拔除导尿管后第1天、第7天托特罗定联合多沙唑嗪组及托特罗定组平均IPSS储尿期分数、平均尿急次数、24小时排尿次数与安慰剂组相比均有明显改善(P<0.05);拔除导尿管后第7天托特罗定联合多沙唑嗪组平均夜尿次数与托特罗定组、安慰剂组相比有显著改善(P<0.05),各组不良反应均可耐受.结论 托特罗定联合多沙唑嗪对于治疗TURP术后的膀胱过度活动症临床疗效确切,其效果优于单独应用托特罗定,且治疗过程中无严重不良反应发生,是一种安全、有效的治疗方案.     

托特罗定治疗女性膀胱过度活动症26例疗效分析

目的探讨女性膀胱过度活动症的治疗方法。方法回顾性分析采用托特罗定治疗26例女性膀胱过度活动症患者的临床资料,并结合文献复习。结果本组26例治疗6～8周后,获得随访21例。随访时间3～12个月,平均6.5个月。其中18/21例有效(85.7%),10/21例症状完全消失(47.6%),8/21症状明显好转(38.1%);3/21例无效(14.5%)。仅少数患者有轻微口干和排尿费力不适反应。结论初步观察,托特罗定是一种治疗女性膀胱过度活动症耐受性好、安全有效的药物。     

托特罗定联合双氯芬酸钠治疗女性膀胱过度活动症

目的 探讨女性膀胱过度活动症有效治疗方法.方法 选择诊断为女性膀胱过度活动症患者57例.随机分为试验组和对照组,试验组20例给予口服托特罗定及双氯芬酸钠;对照I组19例,单纯给予托特罗定;对照Ⅱ组18例,单纯给予双氯芬酸钠.用药时间为4周.以日平均排尿次数、日平均单次尿量、日单次最大尿量为观察指标.观察试验组与对照组用药前后各观察指标变化,并进行统计学分析.结果 试验组与二对照组治疗后各观察指标统计学比较差异有临床意义(P<0.05).结论 托特罗定联合双氯芬酸钠能够更好地改善女性膀胱过度活动症患者临床症状,提高生活质量,疗效确切,方法简便,可推广应用.     

Clinical Efficacy and Safety of Tolterodine Compared to Oxybutynin and Placebo in Patients with Overactive Bladder

This study compared the clinical efficacy (determined from micturition diaries) and safety of 12 weeks’ treatment with either tolterodine 2 mg twice daily, oxybutynin 5 mg three times daily or placebo in patients with an overactive bladder. A total of 277 patients were randomized and treated at 25 centers. Both tolterodine and oxybutynin significantly increased volume voided/micturition compared to placebo. Both treatment groups evoked greater decreases in micturitions per 24 hours and incontinence episodes per 24 hours compared to placebo; however, only tolterodine was significantly better than placebo in reducing micturition frequency. Tolterodine and oxybutynin were equivalent in their effectiveness. Tolterodine was significantly better tolerated than oxybutynin when adverse events (particularly frequency and intensity of dry mouth), dose reduction and patient withdrawals were considered. Oxybutynin is an effective drug whose frequent adverse effects limit its clinical usefulness. Tolterodine has equivalent efficacy to oxybutynin, but with less severe adverse effects. This will allow patients to receive more effective treatment for their condition, with better compliance.     

Tolterodine: As effective but better tolerated than oxybutynin in Asian patients with symptoms of overactive bladder

BACKGROUND: This double-blind, multicenter study compared the efficacy and tolerability of tolterodine (Pharmacia, Los Angeles, USA) with that of oxybutynin (Alza, Palo Alto, USA) in Asian patients with overactive bladder. METHODS: Two-hundred-and-twenty-eight adults with overactive bladder symptoms were randomized to receive tolterodine 2 mg twice daily (bid) (n = 112) or oxybutynin 5 mg bid (n = 116). After 8 weeks' treatment, changes in micturition diary variables, patients' perception of treatment benefit, and tolerability endpoints were determined. RESULTS: The mean (+/- SD) number of micturitions/24 h decreased by 2.6 +/- 2.9 (-21%) with tolterodine and 1.8 +/- 4.2 (-15%) with oxybutynin (both P = 0.0001 vs baseline). The mean number of incontinence episodes/24 h decreased by 2.2 +/- 2.3 (-85%) in the tolterodine group and by 1.4 +/- 1.8 (-58%) in the oxybutynin group (both P = 0.0001 vs baseline). Patient perception of treatment benefit was over 70% in each treatment group. Adverse events were significantly lower in the tolterodine group compared with oxybutynin-treated patients (55% vs 82%; P = 0.001). Dry mouth was reported by significantly fewer patients on tolterodine, compared with oxybutynin (35% vs 63%; P = 0.001) and withdrawals due to adverse events were lower in the tolterodine group than with those treated with oxybutynin (10% vs 16%). There were no safety concerns. CONCLUSIONS: Tolterodine 2 mg bid is equally or more effective than oxybutynin 5 mg bid in the treatment of Asian patients with overactive bladder, and shows significantly better tolerability. This may enhance compliance during long-term treatment.     

Tolterodine: superior tolerability than and comparable efficacy to oxybutynin in individuals 50 years old or older with overactive bladder: a randomized controlled trial

PURPOSE: We compared the tolerability and clinical efficacy of tolterodine with those of oxybutynin in patients with an overactive bladder using an upward oxybutynin dose titration strategy analogous to that used in routine clinical practice in the United Kingdom and Republic of Ireland. MATERIALS AND METHODS: In a randomized double-blind trial 378 male and female patients 50 years old or older with symptoms of overactive bladder (a urinary frequency of 8 or more voids per 24 hours with urgency and/or urge incontinence, that is 1 or more urge incontinence episodes per 24 hours) received 10 weeks of treatment with 2 mg. tolterodine twice daily/or an initial dose of 2.5 mg. oxybutynin twice daily, increasing to 5 mg. twice daily after 2 weeks of treatment. The main outcome measures were changes in voiding diary variables combined with detailed tolerability-safety assessments. RESULTS: Patients treated with tolterodine had significantly fewer adverse events (69% versus 81%, p = 0.01), notably dry mouth (37% versus 61%, p <0.0001), as well as a lower incidence of dose reduction (6% versus 25%, p <0.0001) than those in the oxybutynin group. Each agent had comparable efficacy for improving urinary symptoms. Tolterodine and oxybutynin caused a significant decrease (p = 0.0001) in the mean number of voids per 24 hours (-1.7 or -15% and -1.7 or -15%, respectively), urge incontinence episodes per 24 hours (-1.3 or -54% and -1.8 or -62%, respectively) and mean voided volume per void (33 ml. or 22% and 34 ml. or 23%) after 10 weeks of treatment. CONCLUSIONS: Tolterodine is as effective as oxybutynin for improving the symptoms of overactive bladder but it has superior tolerability. The combination of these qualities makes tolterodine the preferred pharmacological therapy for the long-term treatment of this condition.     

Long-term safety, tolerability and efficacy of extended-release tolterodine in the treatment of overactive bladder in Japanese patients

AIM: To evaluate the long-term safety, tolerability and efficacy of extended-release (ER) tolterodine in Japanese patients completing 12-week treatment in a randomized, double-blind trial comparing tolterodine ER 4 mg once daily, oxybutynin 3 mg three times daily or placebo in patients with overactive bladder. METHODS: Of 293 Japanese patients completing the 12-week study, 188 continued in the open-label trial and received tolterodine ER 4 mg once daily for 12 months, irrespective of previous treatment. The primary objective was to assess the safety of tolterodine ER for up to 52 weeks of treatment and at post-treatment follow-up. Secondary endpoints included changes in micturition diary variables, patient perception of bladder condition and urgency and treatment benefit. RESULTS: Overall, 77% of patients completed 12 months of open-label treatment. Tolterodine ER was well tolerated and the most common adverse event was dry mouth (33.5%). In general, there was no increase in adverse event frequency with long-term treatment compared with short-term treatment. The efficacy of tolterodine ER was maintained over the 12-month period. The complete analysis showed a median reduction in incontinence episodes/week (-92.9%; mean reduction, -77.2%), a mean reduction in micturitions/24 h (-21.3%) and a mean increase in volume voided per micturition (19.6%). Of patients completing the 12-month study, 78.6% reported improvement in patient perception of bladder condition, 52.4% reported improvement in perception of urgency and 89.7% reported treatment benefit. CONCLUSIONS: Favorable safety, tolerability and efficacy of once-daily tolterodine ER was maintained over 12 months in a Japanese overactive bladder patient population.     

Clinical efficacy and tolerability of extended-release tolterodine and immediate-release oxybutynin in Japanese and Korean patients with an overactive bladder: a randomized, placebo-controlled trial

OBJECTIVE: To compare extended-release (ER) tolterodine and immediate-release (IR) oxybutynin with placebo in Japanese and Korean patients with an overactive bladder (OAB). PATIENTS AND METHODS: Men and women aged >or= 20 years with symptoms of urinary urgency, urinary frequency (>or= 8 micturitions/24 h), urge incontinence (>or= 5 episodes/week) and symptoms of OAB for >or= 6 months were randomized to double-blind treatment with tolterodine ER 4 mg once daily, oxybutynin IR 3 mg three times daily or placebo for 12 weeks. Efficacy assessments included changes from baseline in numbers of incontinence episodes per week, voids/24 h and mean volume voided/void. Patient perceptions of bladder condition, urgency and treatment benefit were also assessed. RESULTS: In all, 608 patients were randomized to treatment with tolterodine (240), oxybutynin (246) or placebo (122). More patients prematurely withdrew on oxybutynin (23%) than with tolterodine (10.4%) or placebo (16.4%). After 12 weeks of treatment, the median number of incontinence episodes/week was reduced significantly more in the tolterodine (79%; P= 0.0027) and oxybutynin groups (76.5%; P= 0.0168) than on placebo (46.4%). There were also significantly greater improvements in the number of voids/24 h and volume voided/void with tolterodine and oxybutynin than with placebo. More patients in the tolterodine and oxybutynin than in the placebo groups reported improvements in perceived bladder condition, ability to hold urine and treatment benefit. Patients treated with oxybutynin reported more adverse events than those treated with tolterodine or placebo. Dry mouth was significantly more common with oxybutynin than with tolterodine (53.7% vs. 33.5%; P < 0.001), and occurred in 9.8% of placebo patients. CONCLUSION: Tolterodine ER has similar efficacy but is better tolerated than oxybutynin IR in Japanese and Korean patients with OAB.     

Treatment of overactive bladder: long-term tolerability and efficacy of tolterodine

Previously available antimuscarinic therapies for overactive bladder are poorly tolerated due to a high incidence of adverse events, notably dry mouth. Tolterodine is a bladder-selective, antimuscarinic agent for the treatment of frequency, urgency, and urge incontinence that characterize overactive bladder. In a 9-month open-label study, the safety, tolerability, and clinical efficacy of tolterodine 2 mg twice daily was evaluated in 854 patients with overactive bladder symptoms who had completed one of four 12 week randomized, controlled trials of tolterodine. Safety and tolerability were assessed in terms of adverse events and clinical/laboratory variables. Efficacy was assessed using micturition diaries and patient perception of their bladder condition. In all, 70% of patients remained on treatment for 9 months. Dry mouth was the most frequently reported adverse event, occurring in 28% of patients (intensity: 19% mild, 7% moderate, 2% severe). A total of 9% of patients withdrew due to adverse events. Dosage reduction occurred in 13% of patients. Significant improvements (P < 0.0001) in micturitions per 24 h (−22%), urge incontinence episodes per 24 h (−76%) and volume voided per micturition (+22%) were observed after 9 months of treatment, with 65% of patients reporting an improvement in perception of their bladder problems. The incidence of adverse events and improvements in micturition diary variables during open-label treatment were comparable with those observed during a 12 week randomized treatment. It was concluded that tolterodine is well tolerated and maintains its clinical efficacy during 9 months of treatment. The high proportion of patients remaining on treatment indicates that tolterodine is an effective long-term treatment for overactive bladder.     

A comparison of extended-release oxybutynin and tolterodine for treatment of overactive bladder in women

Women with urge or mixed incontinence were randomized to a daily dose of 10 mg extended-release oxybutynin chloride (qd) or tolterodine tartrate 4 mg (2 mg bid) for 12 weeks. Subjects completed 7-day voiding diaries at baseline and at 12 weeks. A total of 315 women were treated. At the end of the study, extended-release oxybutynin chloride was more effective than twice-daily tolterodine tartrate as measured by urge and total incontinence episodes (p=0.038, p=0.030, respectively). Overall, the reduction in micturition frequency between groups was not significantly different. In women aged 64 years and younger (comprising 63% of the population) extended-release oxybutynin was more effective than tolterodine for urge (p=0.005) and total incontinence (p=0.005), and for micturition frequency (0.024). Adverse events were infrequent, mostly mild, and similar between treatment groups. We concluded that daily extended-release oxybutynin chloride (10 mg) was more effective than tolterodine tartrate (2 mg bid) in treating urge and total incontinence. The incidences of dry mouth, CNS events, and other adverse events were similar for both drugs.     

Effectiveness and tolerability of extended-release oxybutynin vs extended-release tolterodine in women with or without prior anticholinergic treatment for overactive bladder

The efficacy and the tolerability of extended-release oxybutynin chloride, 10 mg daily, and extended-release tolterodine tartrate, 4 mg daily, in women with or without prior anticholinergic treatment for overactive bladder (OAB) were compared in a post-hoc analysis of data from the Overactive Bladder: Performance of Extended Release Agents (OPERA) trial. The patient population and study methods have been described previously (Diokno et al., for the OPERA Study Group, Mayo Clin Proc 78:687–695, 2003). Among the group with anticholinergic experience, extended-release oxybutynin was significantly more effective than extended-release tolterodine in reducing micturition frequency at last observation (p=0.052). Complete freedom from urge incontinence was reported by significantly more patients taking oxybutynin than tolterodine at last observation (23.6 vs 15.1%, p=0.038). In addition, among patients completing a full 12 weeks of oxybutynin treatment, significantly greater reductions were observed compared with those taking tolterodine on the primary efficacy variable, number of urge incontinence episodes (p=0.049), and the combined total of urge and non-urge episodes (p=0.012), although the differences between treatment groups were not significant at last observation. In the anticholinergic-naïve group, efficacy and tolerability outcomes were similar across treatments, except that oxybutynin was associated with a significantly lower frequency of micturition at last observation (p=0.035). No efficacy differences favoring tolterodine were observed, and tolerability of the treatments was comparable. Dry mouth (mostly mild to moderate in severity) was reported significantly more often among participants taking extended-release oxybutynin than extended-release tolterodine (32.2 vs 19.2%, p=0.004), but only among those with previous anticholinergic experience. Discontinuation rates were comparably low across groups. The results demonstrate the appropriateness of initiating treatment for OAB with extended-release oxybutynin, particularly in women presenting with incontinence.     

Retrospective analysis of efficacy and tolerability of tolterodine in children with overactive bladder

OBJECTIVE: To evaluate the efficacy and tolerability of tolterodine in children with an overactive bladder, treated in a single incontinence centre. MATERIALS AND METHODS: A retrospective analysis of a database of a total of two hundred and fifty-six patients (175 boys and 81 girls, age range 3 years to 17 years, mean age 8.33 years) with urodynamically confirmed bladder overactivity was performed. All children received tolterodine tartrate (dose range of 0.5-4 mg orally). In group I (n=205) tolterodine tartrate replaced anticholinergic drugs (AC) (oxybutinin chloride or oxyphencyclimin hydrochloride). A subgroup of patients switched because of intolerance due to serious adverse events (60.4%) or because of lack of improvement in micturition variables (39.6%). In group II tolterodine was prescribed as initial therapy (n=51). Tolerability was assessed by a standardised questionnaire on adverse events at every outdoor clinic visit. Efficacy assessment was based on micturition diary variables, mean change of maximum bladder capacity and number of incontinence episodes/24 h. RESULTS: The mean treatment time was 9.32 months with a range from 1.5 months to 23.4 months. The final dose was 0.1mg/kg orally daily divided into two doses. In group I central nervous system disorders (81%) were the most common adverse events, 26.2% showed flushing, 12.2% accommodation problems and 25.2% had gastrointestinal complaints (constipation, encopresis, abdominal pain). Withdrawal of the non-selective antimuscarinic drug resulted in total recovery from adverse events.Introduction of tolterodine in group I and II caused no serious adverse events. Nine patients (3.5%) reported side-effects and only two discontinued treatment. There were no reports of flushing, troubles of visual accommodation, hyperpyrexia. In group I we observed a mean decrease in urgency by 38.7%, a mean increase in maximal bladder capacity by 33.6% and the number of incontinence episodes decreased by 64.8%. In group II we observed equivalent values with a significant (p<0.001) change in maximal bladder capacity (49.7%), incontinence episodes (64.8%) and micturition episodes/24 h. CONCLUSIONS: The results of this retrospective analysis suggest that tolterodine is well tolerated in children and offers an effective treatment for urinary symptoms due to overactive bladder. Tolterodine is superior to non-selective antimuscarinic drugs, with respect to adverse events, allowing more compliance and more effective treatment in children.     

A new once-daily formulation of tolterodine provides superior efficacy and is well tolerated in women with overactive bladder

 This study evaluated the efficacy and tolerability of new extended-release (ER) tolterodine for the treatment of overactive bladder in women. In this subpopulation analysis of a double-blind multicenter trial, 1235 female patients were randomized to oral therapy with tolterodine ER 4 mg once daily (n=417), tolterodine IR 2 mg twice daily (n=408) or placebo (n=410) for 12 weeks. Both formulations reduced the mean number of urge incontinence episodes per week (both P=0.001 vs placebo); tolterodine ER was more effective than tolterodine IR (P=0.036). Both formulations significantly improved all other micturition chart variables compared to placebo. Dry mouth was the most common adverse event. There were no safety concerns. Toltrodine ER 4 mg once daily is effective and well tolerated in the treatment of women with overactive bladder, and reduces urge incontinence episodes more than the existing IR twice-daily formulation. Received: 15 May 2002 / Accepted: 21 July 2002 Acknowledgement This study was sponsored by a grant from Pharmacia Corporation.