Efficacy and safety of two doses of tolterodine versus placebo in patients with detrusor overactivity and symptoms of frequency, urge incontinence, and urgency: urodynamic evaluation

Summary Tolterodine is a new competitive muscarinic receptor antagonist developed for the treatment of the unstable bladder. A total of 242 patients were enrolled in a multicenter, multinational, randomized, double-blind, placebo-controlled study conducted over a period of 4 weeks in patients with detrusor overactivity and symptoms of frequency, urgency, and urge incontinence. The objective of the study was to compare the efficacy and safety of tolterodine given at 1 or 2 mg b.i.d. versus placebo. At week 4 a statistically significant increase in the volume at first contraction (p = 0.030) and maximal cystometric capacity (p = 0.034) was only in the tolterodine 2 mg b.i.d. group. Tolterodine was safe and generally well tolerated. The incidence of dry mouth, as the most commonly reported adverse event, was only 9% and of mild to moderate intensity.     

Simplified bladder training augments the effectiveness of tolterodine in patients with an overactive bladder

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

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.     

经尿道前列腺电切术后储尿期症状状况分析

目的:通过对经尿道前列腺电切术(TURP)术后下尿路症状(LUTS),尤其是储尿期症状的改变状况分析,提高TRUP术后管理水平和患者生活质量。方法:对我院86例(年龄56～85岁)因患良性前列腺增生(BPH)行TURP者拔除尿管后第1、3、7、15天及第30天进行排尿症状的直接或电话随访,并按术前有和无膀胱逼尿肌不稳定和/或膀胱顺应性差,分为A组和B组。了解两组患者拔管后IPSS评分及储尿期症状评分的变化。结果:86例患者中有15例失访,在有效的71例患者中,其中有膀胱逼尿肌不稳定和/或膀胱顺应性差者28例(A组),不伴有膀胱逼尿肌不稳定和/或膀胱顺应性差者43例(B组)。71例患者拔除尿管后IPSS评分,第1、3、7、15天分别为(8.1±2.5)分、(7.2±3.1)分、(5.3±4.2)分、(6.3±3.8)分、(5.3±4.2)分、(2.4±3.4)分,第1天与第3天比较,以及第15天与第7天比较无统计学差异(P>0.05);而第7天与第1天比较,以及第30天与第15天比较,均有统计学差异(P<0.05)。拔除尿管后第1天LUTS表现以尿频、尿急及急迫性尿失禁等储尿期症状为主,A组IPSS评分(10.4±3.3)分,储尿期症状评分(9.3±3.8)分;B组IPSS评分(6.2±2.8)分,储尿期症状评分(5.2±2.7)分,两组IPSS评分比较及储尿期症状评分比较,均有统计学差异(P<0.05),经舍尼亭及α肾上腺素受体阻滞剂治疗后,拔管后第15天与拔管后第30天两组IPSS评分及储尿期症状评分比较均无统计学差异(P>0.05)。结论:TURP术后排尿症状特别是储尿期症状与术前膀胱功能密切相关且随术后时间推移而逐渐好转。     

Dose-ranging study of tolterodine in patients with detrusor hyperreflexia

Tolterodine is a potent antimuscarinic agent specifically developed for the treatment of urinary urge incontinence and other symptoms related to the overactive bladder. In order to assess the optimum dosage for use in future clinical studies, a double-blind, randomized, placebo-controlled, parallel-group, multicenter study was performed in 90 patients with detrusor hyperreflexia and symptoms of urinary urgency, frequency, and/or urge incontinence. Urodynamic variables, micturition diary variables, and subjective urinary symptoms were measured before and after 2 weeks' treatment with either placebo or tolterodine 0.5, 1, 2, or 4 mg twice daily (bd). Serum drug concentrations, electrocardiogram recordings, blood pressure, and incidence of adverse events were also assessed. Linear regression analysis showed a significant dose-response relationship for several clinically relevant urodynamic variables, while there was a trend towards an improvement in micturition diary variables and subjective assessment of symptoms with increasing dosages of tolterodine. There were no safety or tolerability concerns regarding any of the dosages of tolterodine investigated, although 2 patients treated with a dosage of 4 mg bd experienced urinary retention that necessitated dosage reduction. The results of this study suggest that tolterodine is well-tolerated and exerts a dose-dependent effect on bladder function in patients with detrusor hyperreflexia. The optimum dosage of tolterodine for use in future studies is 1–2 mg bd. Neurourol. Urodynam. 17:499–512, 1998. © 1998 Wiley-Liss, Inc.     

Clinical efficacy of tolterodine with or without a simplified pelvic floor exercise regimen

OBJECTIVES: To investigate whether the combination of tolterodine plus (Tp) a simple pelvic floor muscle exercise (PFME) program would provide improved treatment benefits compared with tolterodine alone (Ta) in patients with symptoms of overactive bladder (OAB). METHODS: After a 1-2 week run-in period, 480 patients with symptoms of urinary frequency (> or =8 micturitions/24 hr), urgency, and urge incontinence (> or =1 episode/24 hr), were randomized to receive tolterodine 2 mg bid with or without a simple PFME program for 24 weeks in this multinational study. Treatment efficacy was assessed by comparing the change from baseline in 3-day micturition diary recordings. RESULTS: After 24 weeks' treatment, in the Ta group the urgency episodes reduced from mean of 4.1 to 1.5 (83% reduction) while in the Tp group the urgency episodes reduced from 4.2 to 2.1 (78.7% reduction). Mean incontinence episodes per day decreased from 3.21 (standard deviation (SD) 3.4) to 0.95 (SD 1.9) in Ta group and from 3.44 (SD 3.4) to 1.25 (SD 2.7) in the Tp group. Similarly, the number of micturition/24 hr were significantly reduced, from 12.78 to 9.20 (27.3% reduction) in the Ta group and from 11.87 to 9.29 (23% reduction) in the Tp group. There was an improvement in the patients' perception of urinary symptoms in 85.9% of patients on Ta and 81.7% patients on Tp PFME. There were no statistically significant differences between the groups with regard to any of the outcome parameters. CONCLUSIONS: Tolterodine therapy for 24 weeks results in significant improvement in urgency, frequency, and incontinence, however, no additional benefit was demonstrated for a simple PFME program.     

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.     

Tolterodine: an overview

Tolterodine has emerged as a new anticholinergic drug to treat detrusor instability in recent years. This substance and its major metabolite DD01 exhibit a favourable effect-to-side-effect ratio for the bladder. Several clinical studies demonstrated the drug's efficacy in reducing the symptoms of an overactive bladder (urgency, urge incontinence and high micturition frequency) and in increasing functional bladder volume. With a clinical effectiveness comparable to oxybutynin, the side effect-profile measures up favourably to oxybutynin. Consequently, though some limitations need to be addressed, tolterodine can be regarded as the drug of first choice to treat overactive bladders in a variety of patient groups: the young (and otherwise healthy), the elderly, as well as in patients with renal and hepatic insufficiency. A new extended release formula of tolterodine has been launched that may improve patients' compliance.     

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

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.     

Perforación de la uretra proximal durante TVT-O,en paciente con desviación uretral secundaria a cirugía de Burch fallida

A 59 years old woman with laparoscopic Burch made during 2003 in another hospital. During 2006, the patient is evaluating in our center for a persistent urinary incontinence, the urodynamic study demonstrated stress urinary incontinence type II and overactive bladder without obstruction evidences. A TVT-O (tension-free vaginal tape obturador in-out route) was made, nevertheless when the right branch was passed blood was observed in the Foley catheter. A cystoscopy showed an important deviation of urethra and the tape through urethra in the proximal portion. The right branch went again inserted taking the necessary precautions. Two days after surgery the Foley catheter was removed and the stress urinary incontinence symptoms disappeared. The urge incontinence symptoms disappeared with the pharmacalogical treatment (Tolterodine 2 mg/day). We believe that the urethral deviation caused by a technically deficient laparoscopic Burch was the reason for the urethral perforation during the TVT-O.     

Does concomitant stress incontinence alter the efficacy of tolterodine in patients with overactive bladder?

PURPOSE: Muscarinic antagonists such as tolterodine are the treatment of choice for overactive bladder (OAB). We determined the impact of concomitant stress incontinence (SI) on the therapeutic effects of tolterodine in patients with OAB with and without concomitant SI. MATERIALS AND METHODS: Data from an open label, observational study involving 2,250 patients with OAB symptoms were analyzed for baseline frequency, urgency and incontinence, and alterations in these symptoms while on 12-week treatment with 2 mg tolterodine twice daily. Data are shown as the mean +/- SD. The statistical significance of differences in treatment effects was determined by multiple regression analysis, adjusting for gender, age and baseline symptom intensity. RESULTS: Concomitant I to III degree SI according to the Stamey grading was present in 31%, 15% and 2% of patients, respectively, and it was associated with increasing basal incontinence, although only III degree SI was associated with greater baseline frequency or urgency. In the overall group tolterodine decreased frequency, urgency and urge incontinence from 12.4 +/- 4.3 to 7.7 +/- 2.7, 8.4 +/- 5.1 to 2.0 +/- 3.0 and 3.4 +/- 4.2 to 0.8 +/- 2.0 episodes daily, respectively. On multiple linear regression analysis I and II degree SI had a minor, if any, effect on this improvement, while III degree SI was statistically associated with a smaller decrease in frequency (by 1.4 +/- 0.4 micturitions daily, p = 0.0002) and incontinence (by 2.1 +/- 0.3 episodes daily, p < 0.0001) but with similar alterations in the number of urge episodes. CONCLUSIONS: Concomitant I or II degree SI has little effect on the efficacy of tolterodine in OAB cases. Only patients with concomitant III degree SI have significantly less improvement.     

Urodynamic and other effects of tolterodine: A novel antimuscarinic drug for the treatment of detrusor overactivity

Tolterodine, a novel compound intended for treatment of urgency and urge incontinence, has been characterized as a potent muscarinic receptor antagonist in pharmacological in vitro and in vivo studies. In cats, tolerodine was shown to reduce bladder pressure at doses significantly lower than those affecting salivation. To predict clinical effectiveness, an open pilot study was performed in healthy male volunteers. Efficacy was measured by cystometry and by spontaneously reported effects after administration of a single oral dose of tolterodine. 6.4 mg, given as a water solution. Tolterodine had distinct inhibitory effects on urinary bladder function, both at 1 and 5 hours post-dose. At 1 hour, but not at 5 hours post-dose tolterodine also significantly reduced stimulated salivation. In addition to the objectively demonstrated changes in urodynamic parameters, most volunteers experienced voiding difficulties. No significant changes in blood pressure, heart rate, or near point of accommodation were registered. Tolterodine, in the dosage used, was both objectively and subjectively shown to exert a marked inhibitory effect on micturition in healthy subjects, and the data suggest a more pronounced effect on bladder function than on salivation. © 1995 Wiley-Liss, Inc.     

Tolterodine is equally effective in patients with mixed incontinence and those with urge incontinence alone

OBJECTIVE: To examine the efficacy of tolterodine, an antimuscarinic agent with a bladder-selective profile, in patients with mixed incontinence (MI, stress and urge) compared with patients with urge incontinence (UI) alone. PATIENTS AND METHODS: The study included 239 patients with MI (urge predominating) and 755 with urge incontinence alone from a single-blind, multicentre trial of 1380 patients (80% female) with an overactive bladder. Those completing the trial were analysed 'per-protocol'. After a 7-day washout and a 3-day run-in to collect baseline information, patients were treated with tolterodine twice daily for 16 weeks. The two groups were compared for incontinence episodes/24 h, voiding frequency, nocturia episodes and pad usage after 16 weeks of treatment. RESULTS: After 16 weeks the median changes from baseline for all voiding variables were statistically significant for the MI and the UI groups (P < 0.001), with no apparent significant between-group differences. The median percentage reduction in incontinence episodes from baseline was 67% for the MI and 75% for the UI groups (P = 0.39). 'Dry' rates for the MI and UI groups at the end of the study were 39% (66/171) and 44% (243/552), respectively, whilst 24% of patients in each group (MI 40/170; UI 130/551) achieved a voiding pattern of < 8 voids/24 h. 'Cure' rates for nocturia and the reduction in the number of patients not using pads used were also similar between the groups. CONCLUSION: Tolterodine is as effective in reducing leakage and other symptoms of an overactive bladder in patients with MI as it is in patients with UI alone.     

Comparison of fesoterodine and tolterodine extended release for the treatment of overactive bladder: a head‐to‐head placebo‐controlled trial

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.     

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.     

Overactive bladder symptoms after midurethral sling surgery in women: Risk factors and management

Introduction

Overactive bladder syndrome (OAB) including urgency and urgency urinary incontinence (UUI) occurs frequently after stress urinary incontinence (SUI) surgery. It is important to identify the risk factors for the occurrence of OAB symptoms in order to adequately inform the patient before surgery. Furthermore, when facing OAB after sling surgery it is crucial to know how to manage these symptoms.

Methods

We conducted a literature review in order to assess the risk factors and management of OAB symptoms after SUI surgery. We searched for relevant articles in PubMed that specifically addressed the topic of OAB symptoms after midurethral sling surgery.

Results

The incidence of de novo and persistent urgency and UUI is reported around 15% and 30%, respectively. Several studies demonstrated that women with mixed incontinence who have a predominant urge component will have worse outcomes after surgery. Older age was also found to be a predictive factor in three studies. Furthermore, urodynamic signs of overactive bladder (eg, DO, low bladder capacity, elevated detrusor pressure) can predict postoperative urgency or UUI. The management of OAB symptoms after SUI surgery is essentially the same as in idiopathic OAB. However, before commencing therapy it is crucial to rule out other factors than can cause urgency, including bladder outlet obstruction, urinary tract infection, or sling erosion.

Conclusions

OAB symptoms are frequently reported after sling surgery. Women with mixed incontinence and older women are at risk of developing post‐operative OAB symptoms. We have proposed an algorithm for the treatment of these symptoms which can be useful in clinical practice.     

Efficacy and tolerability of tolterodine extended-release in continent patients with overactive bladder and nocturia

OBJECTIVE: To evaluate the clinical efficacy and tolerability of tolterodine extended-release (ER) in continent patients with overactive bladder (OAB) and nocturia. PATIENTS AND METHODS: A post hoc analysis was conducted of data from a 12-week, double-blind study of 850 patients randomized to tolterodine ER (4 mg once daily) or placebo, taken within 4 h of going to bed. Patients with a mean of > or = 8 voids/24 h were enrolled, including a mean of > or = 2.5 voids/night. Patients completed 7-day voiding diaries, and for each void an urgency rating was assessed using a 5-point scale (1, none; 5, urgency incontinence); 24-h voids were categorized by urgency rating: total (1-5), non-OAB (1-2), OAB (3-4), and severe OAB (4-5) voids. All adverse events were recorded. RESULTS: The post hoc analysis included 513 patients (243 placebo; 270 tolterodine ER; 58% men) who were continent at baseline; 47% of 24-h voids were classed as non-OAB, and 12% as severe OAB. After 12 weeks of treatment, tolterodine ER significantly reduced mean urgency rating and 24-h OAB, severe OAB, and total voids vs placebo. Tolterodine ER did not affect normal, non-OAB voids, and there were no significant adverse events related to voiding. Other than dry mouth (tolterodine ER, 9% vs placebo, 2%), all the adverse events were reported in <3% of patients; <2% of patients receiving tolterodine ER withdrew because of adverse events. CONCLUSIONS: In continent patients with OAB, tolterodine ER significantly improved urgency rating and reduced 24-h OAB, severe OAB, and total voids, suggesting that it is an effective and well-tolerated treatment option for this subpopulation. More studies are needed to better understand the clinical efficacy of tolterodine ER in this under evaluated group of OAB patients without incontinence.     

托特罗定联合硝苯地平治疗女性膀胱过度活动症的疗效观察

目的探讨托特罗定联合硝苯地平治疗女性膀胱过度活动症（OAB）的疗效。方珐女性OAB患者60例,随机分为2组：A组（30例,托特罗定片2mg,2次／d,连服4周）,B组（30例,托特罗定片并硝苯地平片,5mg,3次／d,连用4周）。治疗前及结束后行ABSS评分。结果A组患者治疗前后尿急评分分别为（3．6±1．O）与（1．8±O．5）分,OABSS评分分别为（10．9±4．8）与（5．3±1．8）分;B组患者治疗前后尿急评分分别为（3．7±0．9）与（O．8±0．1）分,OABSS评分分别为（10．8±1．8）与（3．8±1．7）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）。结论托特罗定联合硝苯地平治疗女性膀胱过度活动症效果较好。     

Comparison of symptom severity and treatment response in patients with incontinent and continent overactive bladder

PURPOSE: Two thirds of patients with overactive bladder (OAB) are continent, but our knowledge on the treatment of the syndrome is largely based on studies with incontinent patients. Therefore, we have explored baseline symptoms and treatment responses to tolterodine in continent relative to incontinent OAB patients. MATERIALS AND METHODS: Data from an open-label, observational study involving 3824 patients with OAB symptoms were analyzed for baseline symptoms and alterations thereof upon a 9 months treatment with 4 mg q.d. tolterodine ER. RESULTS: Baseline symptoms (number of urgency episodes, total urination frequency, daytime frequency, nocturia, and three scales of OAB severity) were similar in 1147 continent and 2571 incontinent patients, the latter having 4.8+/-3.7 incontinence episodes per 24 h. Tolterodine ER-induced reduction of OAB symptoms was very similar in both groups of patients. CONCLUSIONS: The severity of OAB in continent patients can be similar to that in incontinent ones. Symptom improvement upon treatment with tolterodine ER is very similar in both groups. We propose that continent patients may similarly deserve treatment with a muscarinic receptor antagonist as incontinent ones.