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托特罗定 ER 可降低膀胱过度活动症女性的膀胱壁厚度增加。一项随机、安慰剂对照、双盲、平行组研究。

Tolterodine ER reduced increased bladder wall thickness in women with overactive bladder. A randomized, placebo-controlled, double-blind, parallel group study.

机构信息

Department of Urogynaecology, St Marys Hospital, Imperial NHS Trust, Paddington, London, UK.

Department of Epidemiology and Biostatistics, Imperial College London, London, UK.

出版信息

Neurourol Urodyn. 2018 Jan;37(1):237-243. doi: 10.1002/nau.23281. Epub 2017 Apr 13.

DOI:10.1002/nau.23281
PMID:28407338
Abstract

AIMS

We evaluated the effect of Tolterodine extended release (TER) versus placebo on bladder wall thickness (BWT) using transvaginal ultrasound in women with overactive bladder (OAB).

MATERIALS AND METHODS

We recruited 79 women with symptoms of OAB with a mean age of 47 years who had a BWT of at least 5 mm and a post-micturition volume of less than 50 mL at screening. Subjects received TER 4 mg or placebo once daily for the first 12 weeks of the study. For the subsequent 12 weeks, all subjects received TER 4 mg once daily. BWT was measured at screening, weeks 12 and 24. Subjects recorded number of micturitions, incontinence episodes and urgency episodes, and volume voided per micturition at regular intervals during the study.

RESULTS

Treatment with TER for 12 weeks produced a statistically significant decrease from baseline in BWT (mean [SD] = 0.9 [1.4] mm; P < 0.05) that was not evident following treatment with placebo (0.2 [1.6] mm; P = 0.54). However, the treatment difference did not reach statistical significance (LS Mean = -0.4; 95%CI: -1.2, 0.3; P = 0.25). After 12 weeks of treatment, subjects who had taken TER showed an improvement in each bladder diary variable compared to placebo-treated subjects.

CONCLUSIONS

TER may have a direct effect on BWT in women with OAB. Larger studies are warranted to further investigate the effect of behavioral interventions and antimuscarinics, such as TER, on BWT in women with OAB and increased BWT.

摘要

目的

我们通过经阴道超声评估托特罗定缓释片(TER)与安慰剂对膀胱壁厚度(BWT)的影响,以治疗膀胱过度活动症(OAB)女性。

材料与方法

我们招募了 79 名 OAB 症状女性,平均年龄 47 岁,在筛选时 BWT 至少为 5mm,排尿后残余尿量<50ml。受试者接受 TER 4mg 或安慰剂每日一次治疗,为期 12 周。随后 12 周,所有受试者均接受 TER 4mg 每日一次治疗。在筛选、第 12 周和第 24 周时测量 BWT。在研究期间,受试者定期记录排尿次数、尿失禁次数和尿急次数,以及每次排尿的尿量。

结果

TER 治疗 12 周后,BWT 从基线水平呈统计学显著下降(平均[标准差]为 0.9[1.4]mm;P<0.05),而安慰剂治疗后未见明显变化(0.2[1.6]mm;P=0.54)。然而,治疗差异未达到统计学意义(LS 均值为-0.4;95%CI:-1.2,0.3;P=0.25)。在治疗 12 周后,与安慰剂治疗组相比,服用 TER 的受试者在每个膀胱日记变量中均有改善。

结论

TER 可能对 OAB 女性的 BWT 有直接作用。需要更大规模的研究进一步探讨行为干预和抗毒蕈碱药物(如 TER)对 OAB 女性和 BWT 增加的影响。

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