索利那新治疗膀胱过度活动症106例报告

目的评价索利那新治疗膀胱过度活动症（OAB）的疗效。方法对106例诊断OAB的患者口服索利那新,5mg,每天1次;治疗前后患者填写排尿日记,疗程4周,以膀胱过度活动症评分（OABSS）为观察指标。结果治疗后患者OABSS较治疗前改善,两者差异有统计学意义（P〈0.05）。结论索利那新具有更高的膀胱选择性,疗效确切,药物耐受性好,值得推荐临床一线用药。     

索利那新治疗膀胱过度活动症的有效性及安全性分析

目的 评价索利那新治疗膀胱过度活动症(OAB)的有效性及安全性. 方法采用多中心临床试验方法,对216例OAB患者予每日口服5 mg索利那新,连续用药5周,记录用药前后排尿日记及用药不良反应,比较用药前后平均24 h尿急次数、平均24 h排尿次数、夜尿次数、平均尿量、尿失禁次数及QOL评分的改善情况.采用SPSS 13.0统计软件对疗效和安全性进行分析. 结果 216例患者应用索利那新治疗5周,治愈187例(86.7%),其中43例(19.9%)用药3周后基本恢复正常排尿,29例(13.4%)明显好转,24 h平均尿急次数中位数由用药前的4.1(0.9～18.6)次减至用药后的0.6(0～17.9)次,其中27例急迫性尿失禁患者24 h尿失禁次数中位数由用药前的1.9(0.6～16.4)次减至用药后的0.5(0～3.4)次,QOL评分由用药前的4.3±0.3降至用药后的1.1±0.2,用药前后比较差异均有统计学意义(P<0.05).11例(5.0%)用药后发生轻微口干、眼干症状,未观察到严重不良反应. 结论 索利那新能有效改善OAB患者尿急、尿频、夜尿及尿失禁症状,不良反应小,治疗OAB安全有效.     

索利那新加坦索罗辛治疗膀胱过度活动症的疗效分析

目的 探讨索利那新加坦索罗辛治疗膀胱过度活动症(OAB)的疗效.方法 OAB患者53例,男15例,女38例.年龄29～72岁,平均43岁.随机分为2组,A组为单用索利那新组(27例),B组为索利那新加用坦索罗辛组(26例).服药方法:索利那新5 mg/d,坦索罗辛0.2 mg/d.连续14 d后随访,再进行OABSS评分.结果 A组患者治疗前后尿急评分分别为(3.3±1.0)与(1.9±0.6)分,OABSS评分分别为(10.8±4.9)与(5.2±1.8)分;B组患者治疗前后尿急评分分别为(3.6±1.0)与(0.9±0.1)分,OABSS评分分别为(10.7±1.9)与(3.9±1.8)分,2组治疗前后差异均有统计学意义(P＜0.05),2组治疗后尿急评分和OABSS评分差异有统计学意义(P＜0.05).结论 索利那新加用坦索罗辛可以有效缓解OAB患者的尿急症状并降低OABSS评分,索利那新加用坦索罗辛疗效好于单用索利那新.

Abstract：

Objective To evaluate the efficacy of solifenacin with or without tamsulosin in patients with overactive bladder (OAB).Methods Fifty-three patients with OAB were randomly divided into two groups (group A 27 patients, group B 26 patients).The patients received either solifenacin 5 mg/day in group A or combined with Tamsulosin 0.2 mg/day in group B for two weeks.During the treatent period all the patients recorded voiding and adverse events in a diary.The symptoms of urgency, frequency, incontinence were evaluated by OABSS scores at the begining and end of the therapy period.The results of the efficacy and safety were analyzed by using SPSS 13.0.Results The OABSS scores at the begining and end for the two groups were significantly different ( P ＜ 0.01 ).In both groups the efficacy was obvious.The OABSS scores at the end of the therapy between group A and B were significantly different (P ＜0.05 ).The efficacy of group B was better than that of group A.Conclusion The efficacy of solifenacin combined with tamsulosin was better than solifenacin alone in OAB.     

索利那新治疗经尿道前列腺电切术后膀胱过度活动症的疗效分析

目的 探讨索利那新治疗经尿道前列腺电切(TURP)术后膀胱过度活动症(OAB)的疗效及安全性.方法 观察64例TURP术后OAB患者拔除尿管当天的排尿情况.根据OAB症状评分(OABSS),按OAB轻、中、重度进行配对后随机分为实验组和对照组,每组各32例.实验组:于拔除尿管后次日起口服索利那新(5 mg,1次/d)2周;对照组:无相关辅助治疗.比较2组拔除尿管后第7、14天的24 h尿急次数、排尿次数、夜尿次数、急迫性尿失禁次数、平均每次尿量、Qmax及OABSS评分.观察实验组治疗期间的不良事件.患者拔除尿管后随访8周.结果 实验组拔管后第7、14天的24 h尿急次数(2.0±1.2,1.1±0.9)、排尿次数(9.7±0.9,7.8±0.9)、夜尿次数(2.2±0.5,1.1±0.6)、急迫性尿失禁次数(0.8±0.7,0.5±0.5)、OABSS评分(7.3±3.1,4.0±2.8)均显著低于对照组的(2.9±1.7,2.2±1.4)、(10.5±1.1,9.6±0.9)、(2.9±0.5,1.8±0.5)、(1.6±1.0,1.1±0.8)、(8.1±3.1,7.6±3.3),2组比较差异均有统计学意义(P均＜0.01);实验组平均每次尿量[(183.0±38.3)、(203.2±51.1)ml]显著高于对照组[(172.6±35.3)、(178.4±38.2)ml],差异有统计学意义(P＜0.01).实验组在治疗期间不良反应总发生率为12.5%(4/32),但患者均可耐受,未发生严重不良事件.结论 索利那新治疗TURP术后OAB症状安全、有效,可于TURP术后早期应用.

Abstract：

Objective To evaluate the efficacy and safety of solifenacin in the treatment of overactive bladder (OAB) syndrome in patients who have undergone transurethral resection of the prostate (TURP). Methods According to the Overactive Bladder Symptom Score (OABSS), 64 cases with OAB symptoms after TURP were randomly assigned into study and control groups with 32 cases in each group. Patients in the study group were treated with solifenacin (5 mg once daily) for a two week period beginning the first day after catheter removal. Patients in the control group were not treated with solifenacin. The mean urgency episodes, micturition episodes, nocturia, urge incontinence, volume voided per micturition, Qmax and OABSS scores were recorded on the 7th and the 14th day after catheter removal. Treatment-emergent adverse events with solifenacin in the study group were recorded and evaluated as well. All cases were followed-up for 8 weeks after catheter removal. Results There were statistically significant differences (P<0.01) in favor of the study group over the control group in the aspect of urgency, micturition episodes, nocturia, urge incontinence, volume voided per micturition and OABSS scores. The incidences of treatment related adverse events were 12.5% (4/32) in the study group with no serious adverse event observed. Conclusions Solifenacin is effective in the treatment of OAB syndrome after TURP and is well tolerated as well. Application of solifenacin should be recommended earlier after TURP.     

索利那新治疗前列腺电切术后膀胱过度活动症的临床观察

目的比较索利那新及托特罗定治疗经尿道前列腺电切术（TURP）术后患者膀胱过度活动症（OAB）的有效性与安全性。方法选取126例TURP后出现OAB症状的患者,随机分为4组：A组（索利那新5mg,1次/d）,B组（索利那新10mg,1次/d）,C组（托特罗定2mg,2次/d）,D组（安慰剂组）。术后6h开始服药,观察治疗前及拔管后7d日间排尿次数、夜间排尿次数、尿急、急迫性尿失禁以及对日常生活造成的影响。进一步进行OAB症状评分表（OABSS）评分和感知膀胱症状量表（PPBC）评分;观察各组口干、便秘、视力模糊症状等不良反应的发生率以及肝功能、肾功能指标变化。结果拔管后7d,A、B、C组与D组OABSS及PPBC评分有显著性差异（P〈0.05）,A、B组,B、C组,A、C组之间无显著性差异（P〉0.05）。A组2例出现口干,1例便秘;B组5例口干,3例便秘,2例视力模糊;C组有4例口干,2例便秘,1例视力模糊;D组仅1例便秘。各组第7d复查的肝功能、肾功能与术前相比无统计学差异（P〉0.05）。结论索利那新治疗TURP术后OAB症状比托特罗定更安全,5mg足以发挥疗效,副作用更少。     

索利那新治疗膀胱过度活动症对逼尿肌功能的影响

目的 评估索利那新治疗膀胱过度活动症(overactive bladder,OAB)患者12周前后逼尿肌功能的变化.方法 2010年3-7月,20例OAB患者服用索利那新治疗.男12例,女8例.年龄21～83岁,平均43岁.病程1～20年,平均8年.患者连续服用索利那新5 mg/d 12周.服药前后行尿动力学检查,观察逼尿肌功能变化、记录OABSS得分、感知膀胱症状量表(PPBC)评分,统计学比较治疗前后的差异.结果 患者治疗前后平均逼尿肌无抑制收缩波个数分别为2.3±2.4与0.6±1.3,差异有统计学意义(P＜0.05);其中6例患者服药后逼尿肌无抑制收缩完全消失.治疗前后膀胱初次排尿感容量(103±67 ml与178±89 ml)、膀胱容量(189±133 ml与299±89 ml)差异有统计学意义(P＜0.01);膀胱顺应性、最大尿流率时逼尿肌压力差异无统计学意义(P＞0.05).服药前后OABSS量表的尿急评分(5.0±0.0与2.8±2.0)、白天排尿评分(1.3±0.5与0.4±0.7)、夜尿评分(2.9±0.4与1.4±0.92)、尿失禁评分(3.3±2.1与1.6±2.1)、PPBC评分(5.5±0.5与2.9±1.6)差异均有统计学意义(P＜0.05).6例患者诉有口干现象.结论 索利那新12周治疗可明显降低OAB患者逼尿肌无抑制收缩,增加逼尿肌储尿量,减少OAB症状,提高生活质量.

Abstract：

Objective To investigate the effects of solifenacin on the detrusor instability of patients with overactive bladder (OAB).Methods A total of 20 outpatients with OAB of.1 - 20 ( mean, 8 )years, 12 males and 8 females, aged 21 - 83 ( mean, 43) years were included in this study.Five mg solifenacin was given orally once daily for 12 weeks.Before and after treatment, overactive bladder symptom score (OABSS), patient perception of bladder condition symptoms rating scale (PPBC), and filling cystometry was performed.Results Before and after solifenacin administration, significant decrease were detected in term of unstable detrusor waves ( 2.3 ± 2.4) vs (0.6 ± 1.3 ) ( P ＜ 0.05 ), and detrusor overactivity ( DO ) disappeared in 6 patients.Bladder capacities at first desire to void and maximum bladder capacity were significantly increased (P ＜0.01 ).Bladder compliance and detrusor pressure at maximum urine flow had no significant difference (P ＞ 0.05 ).All patients had significant improvement in OAB symptoms evaluating by OABSS and PPBC ( P ＜ 0.05 ).Six patients had mild side effect of dry mouth and could be relieved by drinking more water.Conclusion Urodynamically, solifenacin decreases the detrusor overactivity, increases the bladder capacity and improves the quality of life of OAB patients.     

高选择性M受体阻滞剂治疗高龄BPH患者膀胱过度活动症的疗效及安全性

目的探讨高选择性M受体阻滞剂索利那新治疗高龄BPH患者膀胱过度活动症（OAB）的疗效及安全性。方法选取2010年7月至2011年5月于我院泌尿外科门诊就诊、年龄≥75岁、确诊为OAB的BPH患者30例,给予索利那新治疗,每日1次,每次5mg,治疗周期3个月。治疗前后以排尿日记、国际前列腺症状评分（IPSS）、膀胱过度活动症状评分（OABSS）、患者感知膀胱症状情况分级量表（PPBC）、生活质量评分（QOL）为主要疗效指标,对疗效及服药安全性进行评价。结果治疗后的24h平均尿急次数、24h平均排尿次数、夜尿次数及每周尿失禁次数均较治疗前好转;IPSS、OABSS、PPBC、QOL评分均低于治疗前,差异具有统计学意义（均P〈0.05）。9例患者出现轻度口干、便秘等不良反应,均能耐受,对症治疗后缓解。2例患者出现排尿困难情况,停药1周并加用α受体阻滞剂后缓解。结论高选择性M受体阻滞剂索利那新治疗高龄BPH患者的膀胱过度活动症疗效较好,不良反应轻,是一种相对安全有效的药物治疗方法。     

索利那新对膀胱过度活动症病人逼尿肌功能及预后的影响

目的探究索利那新对膀胱过度活动症(overactive bladder,OAB)病人逼尿肌功能及预后的影响。方法 OAB病人128例,根据不同的治疗方法分为对照组与研究组,每组各64例。对照组采用托特罗定治疗,研究组采用索利那新治疗,服药时间为8周。比较两组病人尿动力参数、膀胱过度活动症症状评分(overactive bladder symptom score,OABSS)以及不良反应情况。结果研究组服药后膀胱顺应性、逼尿无抑制收缩次数、膀胱初次排尿感、最大膀胱容量、最大尿流率分别为(53.1±26.4)ml/cm H_2O、(1.5±1.2)次、(177.0±88.0)ml、(298.0±88.0)ml和(53.4±17.1)ml/s,对照组分别为(58.2±29.5)ml/cm H_2O、(1.9±1.5)次、(155.0±90.0)ml、(275.0±98.0)ml和(54.0±20.1)ml/s,两组比较差异有统计学意义(P0.05)。研究组和对照组服药后OABSS评分分别为(5.9±2.4)分和(6.7±3.4)分,差异有统计学意义(P0.05)。研究组不良发生率为4.6%,对照组为14.0%,差异有统计学意义(P0.05)。结论索利那新对治疗OAB,临床效果满意,不良反应轻微。     

小儿膀胱过度活动症106例治疗报告

目的探讨小儿膀胱过度活动症的临床特点及治疗方法。方法回顾分析近5年门诊收治的106例小儿膀胱过度活动症的临床表现、个性化治疗方法及疗效。结果38例学龄前患儿经心理疏导、改变生活习惯等方法治疗,30例治愈,治愈率78．9％。其余76例患儿予口服654．2片,其中58例治愈,治愈率76．3％;另18例加服硝苯吡啶联合治疗,16例治愈,2例好转。总治愈率98．1％。结论小儿膀胱过度活动症治疗应根据个人特点采取个性化治疗方案,治愈后复发率低。     

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.     

坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的临床观察

目的 探讨坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症的有效性及安全性。 方法 本组良性前列腺增生伴膀胱过度活动症患者82例。年龄50～75岁,平均57岁。入选标准：平均每天排尿次数≥8次,夜间≥2次,每次尿量＜200 ml;膀胱过度活动症症状评分(OABSS)：第3项评分＞2分,总分＞3分。采用随机对照方法,分为对照组（38例）和实验组(44例)。2组临床指标比较差异无统计学意义(P＞0.05)。对照组口服坦索罗辛0.2 mg,每日1次,共12周;实验组口服坦索罗辛0.2 mg,每日1次,索利那新5 mg,每日1次,共12周。比较2组治疗前后国际前列腺症状评分(IPSS)、排尿期症状评分、储尿期症状评分、最大尿流率(Qmax)、残余尿量、OABSS、尿常规检查、不良事件登记等。 结果 ①对照组治疗前后IPSS评分(19.5±2.2 vs 15.6±2.4)、排尿期症状评分(15.6±2.4 vs3.4±1.7)、Qmax(13.7±3.8 vs16.6±4.1),治疗前后比较差异有统计学意义（P值均＜0.05）。②实验组治疗前后IPSS评分(19.7±2.3 vs9.7±3.0)、储尿期症状评分（13.8±1.9 vs5.6±1.6）、OABSS( 10.3±1.8 vs5.3±1.3)、Qmax(14.1±4.1 vs 17.2±3.5),治疗前后比较差异有统计学意义（P值均＜0.05）。③治疗后实验组与对照组IPSS评分(9.7±3.0 vs15.6±2.4)、储尿期症状评分(5.6±1.6 vs 12.0±1.6,)、OABSS(5.3±1.3 vs9.7±2.7)比较差异有统计学意义（P值均＜0.05）。实验组与对照组排尿期症状评分(3.4±1.1 vs3.4±1.7)、Qmax (17.2±3.5 vs 16.6±4.1)、残余尿量(36.7±17.1 vs 35.7±12.5)比较差异无统计学意义(P值均＞0.05)。2组均无急性尿潴留发生,对照组总体不良反应发生率为7.9％( 3/38),实验组总体不良反应发生率为20.5％ (9/44)。 结论 坦索罗辛联合索利那新治疗良性前列腺增生伴膀胱过度活动症有效、安全,疗效优于单用坦索罗辛。     

Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction

Study Type – Symptom prevalence (prospective cohort) Level of Evidence 1b What’s known on the subject? and What does the study add? Few prevalence studies used current ICS LUTS symptom definitions and to our knowledge no studies exist that estimate total worldwide prevalence of reported LUTS symptoms. One of the primary goals of this analysis was to estimate current and future worldwide prevalence of LUTS among adults. Our estimation model suggests that LUTS are highly prevalent worldwide, with an increasing burden predicted over time.

OBJECTIVE

? To estimate and predict worldwide and regional prevalence of lower urinary tract symptoms (LUTS), overactive bladder (OAB), urinary incontinence (UI) and LUTS suggestive of bladder outlet obstruction (LUTS/BOO) in 2008, 2013 and 2018 based on current International Continence Society symptom definitions in adults aged ≥20 years.

PATIENTS AND METHODS

? Numbers and prevalence of individuals affected by each condition were calculated with an estimation model using gender‐ and age‐stratified prevalence data from the EPIC study along with gender‐ and age‐stratified worldwide and regional population estimates from the US Census Bureau International Data Base.

RESULTS

? An estimated 45.2%, 10.7%, 8.2% and 21.5% of the 2008 worldwide population (4.3 billion) was affected by at least one LUTS, OAB, UI and LUTS/BOO, respectively. By 2018, an estimated 2.3 billion individuals will be affected by at least one LUTS (18.4% increase), 546 million by OAB (20.1%), 423 million by UI (21.6%) and 1.1 billion by LUTS/BOO (18.5%). ? The regional burden of these conditions is estimated to be greatest in Asia, with numbers of affected individuals expected to increase most in the developing regions of Africa (30.1–31.1% increase across conditions, 2008–2018), South America (20.5–24.7%) and Asia (19.7–24.4%).

CONCLUSIONS

? This model suggests that LUTS, OAB, UI and LUTS/BOO are highly prevalent conditions worldwide. Numbers of affected individuals are projected to increase with time, with the greatest increase in burden anticipated in developing regions. ? There are important worldwide public‐health and clinical management implications to be considered over the next decade to effectively prevent and manage these conditions.     

Refractory overactive bladder after urethrolysis for bladder outlet obstruction: management with sacral neuromodulation

Refractory overactive bladder (OAB) after urethrolysis for iatrogenic bladder outlet obstruction (BOO) is a clinical dilemma without established guidelines for management. We sought to evaluate the efficacy of sacral neuromodulation (SNM) in the management of this complex patient population. Retrospective review identified eight patients who underwent SNM secondary to refractory OAB after urethrolysis or sling take-down. SNM was performed with the Interstim® device (Medtronic, Minneapolis) using a two-stage implant technique. SNM outcomes were determined subjectively during follow-up. Validated questionnaires were completed to assess symptom bother, patient satisfaction, and quality of life. Statistical analyses were conducted using Stata® version 9.0. Six patients had a favorable response to SNM during test stimulation and underwent implantation of the implantable pulse generator (IPG). With follow-up of 15.7?±?11.1 months (6–34), all patients significantly improved, with three patients being dry and three patients having one to two urgency incontinence episodes per week. Patient-reported outcomes indicated that patients perceived themselves as very much improved (3) or much improved (3) after SNM, while those failing test stimulation perceived no change. Quality of life and symptom bother were significantly better in SNM responders vs nonresponders. SNM appears to be an effective and viable treatment option in this complex patient population. Further work is needed to determine clinical factors predictive of outcome and durability of response.     

胎儿镜在胎儿下尿路梗阻中的应用

目的探讨胎儿镜在胎儿下尿路梗阻诊治中的应用。 方法局部麻醉下,通过超声引导,向胎儿膀胱置入胎儿镜,通过胎儿镜直接观察梗阻部位,区分下尿路梗阻原因,如后尿道瓣膜、尿道闭锁及尿道狭窄等。 结果成功向胎儿膀胱内置入胎儿镜,明确胎儿下尿路梗阻的病因为尿道闭锁,经胎儿亲属同意给予进一步行膀胱羊膜腔引流术。 结论此项技术操作难度大,孕妇及胎儿的手术风险大,必须是在有开展此项技术的医学中心进行手术。并且,胎儿必须满足因羊水严重过少导致宫内或新生儿期有极高死亡风险的条件,才能进行此项手术。产前干预对胎儿的获益,如预防肺发育不全、保护肾及膀胱功能等,暂时未明确,仍需更多的研究来证实。     

索利那新联合坦索罗辛治疗经尿道前列腺电切术术后膀胱过度活动症

目的探讨索利那新联合盐酸坦索罗辛预防性治疗经尿道前列腺电切术（TURP）后膀胱过度活动症的疗效。方法收集84例良性前列腺增生症患者的基本资料,发病年龄52～0（72．34-6．4）岁,随机分为4组：联合药物组、索利那新组、坦索罗辛组及对照组各21例。比较各组TuRP术后3d内膀胱区阵发性痉挛性疼痛的次数、膀胱痉挛持续时间及拔管后第1天和第3天尿频、尿急的情况。结果各组在术后3d内膀胱痉挛次数、膀胱痉挛平均持续时间均少于对照组（P〈O．05）;索利那新组术后第2、第3天膀胱痉挛次数分别为（1．64±0．42）次和（1．28±o．65）次,膀胱痉挛平均持续时间分别为（0.1±0．18）h和（0．20±0．07）h,少于盐酸坦索罗辛组（3．03±0．28）次和（2．18±0．58）次、（O．28±0．15）h和（0．23±0．11）h。联合药物组膀胱痉挛次数（1．334±0．31）次和（0.88±0.21）次,其持续时间为（0.184±0．11）h和（0．15±0．10）h,少于索利那新组（P〈0．05）。拔管后第1、3天,索利那新联合坦索罗辛组患者的尿频、尿急次数明显低于索利那新组和盐酸坦索罗辛组（P〈O．05）。结论早期预防性联合应用索利那新与坦索罗辛可能是一种安全有效的缓解患者TuRP术后膀胱过度活动症的方法,有助于患者的术后恢复和生活质量的提高。     

Randomised,Multicentre, Placebo-controlled,Double-blind Crossover Study Investigating the Effect of Solifenacin and Oxybutynin in Elderly People with Mild Cognitive Impairment: The SENIOR Study

Background

Compared with younger people, the elderly are more likely to suffer from overactive bladder (OAB) and to have other chronic conditions that affect physical or cognitive function. Despite this, there are few data on the cognitive safety of antimuscarinic agents in older patients and none that examine the effect of these agents on those with mild cognitive impairment (MCI).

Objective

To evaluate cognitive effects during chronic stable dosing with solifenacin and oxybutynin versus placebo in older (≥75 yr) subjects with MCI.

Design, setting, and participants

A randomised, double-blind, triple-crossover trial in 26 elderly volunteers with MCI. Cognitive function was assessed using Cognitive Drug Research (CDR) computerised testing.

Intervention

Three treatment periods of 21 d each with solifenacin 5 mg once daily, oxybutynin 5 mg twice daily, or placebo, separated by 21-d washout periods.

Outcome measurements and statistical analysis

The primary end point was change from baseline in cognitive function with solifenacin at 6 h postdose and oxybutynin at 2 h postdose (time points close to their predicted time to peak concentration). Secondary end points included change in cognitive function at additional time points, and safety and tolerability assessments.

Results and limitations

Neither agent was associated with significant changes from baseline in any of the five standard, composite outcomes of cognitive function (power of attention, continuity of attention, quality of working memory, quality of episodic memory, and speed of memory). In a secondary analysis, oxybutynin was associated with significant decreases in power and continuity of attention versus placebo at 1–2 h postdose. Both agents were well tolerated, with the most frequently reported adverse event being mild or moderate dry mouth.

Conclusions

Solifenacin had no detectable effect on cognition in this group of elderly people with MCI.