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特发性逼尿肌过度活动症中膀胱内注射肉毒杆菌毒素注射部位减少后的尿动力学变化:一项双盲前瞻性随机临床试验

Urodynamic Changes Following Fewer Injection Sites of Intravesical Botulinum Toxin in Idiopathic Detrusor Overactivity: A Double-Blinded Prospective Randomized Clinical Trial.

作者信息

Soleimanifard Niloofar, Nayeri Reza Kaffash, Moghimian Mehran, Tayebi Sona, Emami Maryam

机构信息

Shahid Labbafinejad Medical Center, The Center of Excellence in Urology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

Department of Urology, Hasheminejad Kidney Center, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Int Urogynecol J. 2025 Mar;36(3):567-574. doi: 10.1007/s00192-024-06009-6. Epub 2025 Jan 4.

Abstract

INTRODUCTION AND HYPOTHESIS

This study was aimed at evaluating the therapeutic effects of a modified intravesical botulinum toxin injection technique (fewer injection sites under local anesthesia), in comparison with the conventional technique for patients with idiopathic detrusor overactivity, considering the urodynamic parameters.

METHODS

In this double-blinded randomized clinical trial, 78 adult females with idiopathic detrusor overactivity were divided into two groups: conventional and modified groups. In the conventional method, patients received intradetrusor botulinum toxin injection at 20 sites under general or spinal anesthesia in a trigone-sparing fashion. In the modified group, injections were performed at five intradetrusor sites beyond the trigone, using local anesthetics. The primary end point was the comparison of urodynamic parameters in both groups following the procedure. The secondary endpoints were assessing the safety and tolerability of the modified method compared with the conventional method.

RESULTS

There were no significant differences between the two treatment groups in terms of urodynamic parameters before the intervention (p > 0.05). After the intervention, no significant differences in urodynamic parameters were observed between the two treatment methods. All patients in the modified-method group could tolerate the procedure well.

CONCLUSION

The innovation of reducing the number of injection sites and concurrently using local anesthetics was shown to be as effective as the conventional method in terms of improving urodynamic parameters, tolerability, and safety in patients with idiopathic detrusor overactivity.

摘要

引言与假设

本研究旨在评估改良型膀胱内注射肉毒杆菌毒素技术(局部麻醉下注射部位更少)与传统技术相比,对特发性逼尿肌过度活动患者的治疗效果,并考虑尿动力学参数。

方法

在这项双盲随机临床试验中,78名患有特发性逼尿肌过度活动的成年女性被分为两组:传统组和改良组。在传统方法中,患者在全身或脊髓麻醉下,以保留三角区的方式在20个部位进行膀胱逼尿肌内注射肉毒杆菌毒素。在改良组中,使用局部麻醉剂在三角区以外的五个膀胱逼尿肌内部位进行注射。主要终点是术后两组尿动力学参数的比较。次要终点是评估改良方法与传统方法相比的安全性和耐受性。

结果

干预前,两个治疗组在尿动力学参数方面无显著差异(p > 0.05)。干预后,两种治疗方法在尿动力学参数方面未观察到显著差异。改良方法组的所有患者对该操作耐受性良好。

结论

减少注射部位数量并同时使用局部麻醉剂的创新方法在改善特发性逼尿肌过度活动患者的尿动力学参数、耐受性和安全性方面与传统方法一样有效。

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