Background

Low-intensity shockwave therapy (Li-SWT) can improve bladder function through enhancement of angiogenesis and nerve regeneration and suppression of inflammation and overactivity. In this trial, we aimed to evaluate the efficacy of Li-SWT on persistent storage symptoms after transurethral surgery (TUS) for benign prostatic obstruction (BPO).

Methods

Between July 2020 and July 2022, 137 patients with persistent storage symptoms; urgency episodes/24 h ≥ 1 and daytime frequency ≥8, for at least three months after TUS for BPO were randomly allocated to Li-SWT versus sham versus solifenacin 10 mg/day in 3:1:1 ratio. The primary end point was the percent reduction from baseline in overactive bladder symptom score (OABSS) at 3-month follow-up. The changes in 3-day voiding diary parameters, quality of life (QoL) score, peak flow rate and residual urine at 3 and 6-month follow-up were compared. Treatment-related adverse effects were also evaluated.

Results

Baseline data were comparable between groups. The percent reduction from baseline in OABSS at 3-month follow-up was significantly higher in Li-SWT compared to sham (−55% versus −11%), and it was comparable between Li-SWT and solifenacin-10 (−55% versus −60%). Li-SWT achieved significant improvement like solifenacin-10 in 3-day voiding diary parameters and QoL score at 3-month follow-up. This improvement remained comparable between Li-SWT and solifenacin-10 at 6-month follow-up. No adverse effects related to Li-SWT were noted apart from tolerable pain during the procedure. Solifenacin-10 was associated with bothersome adverse effects in 73% of the patients with 11.5% discontinuation rate.

Conclusions

Li-SWT ameliorates persistent storage symptoms and promotes QoL after TUS for BPO, with comparable efficacy and better tolerance compared to solifenacin.

中文翻译：

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一项评估低强度冲击波疗法治疗良性前列腺梗阻经尿道手术后持续性储存症状的随机对照试验

背景

低强度冲击波疗法（Li-SWT）可以通过增强血管生成和神经再生以及抑制炎症和过度活动来改善膀胱功能。在本试验中，我们的目的是评估 Li-SWT 对良性前列腺梗阻 (BPO) 经尿道手术 (TUS) 后持续性储存症状的疗效。

方法

2020年7月至2022年7月期间，有137名患者出现持续性储存症状； BPO TUS 后至少三个月内，每 24 小时尿急发作次数≥1 次且日间频率≥8 次，按 3:1:1 的比例随机分配至 Li-SWT、假手术组和索利那新 10 mg/天。主要终点是 3 个月随访时膀胱过度活动症状评分 (OABSS) 较基线的下降百分比。比较随访 3 个月和 6 个月时 3 天排尿日记参数、生活质量 (QoL) 评分、峰值尿流率和残余尿的变化。还评估了与治疗相关的不良反应。

结果

组间基线数据具有可比性。与假手术相比，3 个月随访时，Li-SWT 中 OABSS 相对于基线的降低百分比显着更高（−55% 与 -11%），并且 Li-SWT 和 solifenacin-10 之间的百分比相当（−55%）对比-60%）。 Li-SWT 与 solifenacin-10 一样，在 3 天排尿日记参数和 3 个月随访时的生活质量评分方面取得了显着改善。在 6 个月的随访中，Li-SWT 和 solifenacin-10 的这种改善仍然具有可比性。除了手术过程中可忍受的疼痛外，没有发现与 Li-SWT 相关的不良反应。 Solifenacin-10 与 73% 的患者出现令人烦恼的不良反应相关，停药率为 11.5%。

结论

Li-SWT 可改善 BPO TUS 后的持续储存症状并提高生活质量，与索利那新相比具有相当的疗效和更好的耐受性。