Efficacy and safety of Vibegron for the treatment of residual overactive bladder symptoms after laser vaporization of the prostate: A single-center prospective randomized controlled trial (VAPOR TRIAL)

IF 1.5 4区医学 Q3 UROLOGY & NEPHROLOGY

LUTS: Lower Urinary Tract Symptoms Pub Date : 2024-07-02 DOI:10.1111/luts.12529

Narihito Seki, Hiroyuki Masaoka, Yoohyun Song, Takashi Dejima, Yoshiaki Sato, Shotaro Maeda

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引用次数: 0

Abstract

Objectives

This study aimed to evaluate the efficacy and safety of Vibegron for the treatment of residual overactive bladder (OAB) symptoms after laser vaporization of the prostate (photo-selective vaporization of the prostate, contact laser vaporization of the prostate, and thulium laser vaporization).

Methods

This randomized, open-label, parallel-group, single-center superiority trial with a 12-week observation (jRCTs071190040) enrolled male patients with OAB aged 40 years or older who had undergone laser vaporization of the prostate for not less than 12 weeks and not more than 1 year earlier. Patients were allocated to receive Vibegron 50 mg once daily or follow-up without treatment for 12 weeks.

Results

Forty-seven patients were enrolled between January 2020 and March 2023. The median age (interquartile range) was 75.5 (72.5–78.5) years for the Vibegron group and 76.5 (71.0–81.0) years for the control group. The intergroup difference in the mean change (95% confidence interval) in the 24-hour urinary frequency at 12 weeks after randomization was −3.66 (−4.99, −2.33), with a significant decrease for the Vibegron group. The Overactive Bladder Symptom Score, International Prostate Symptom Score, IPSS storage score, and Overactive Bladder Questionnaire score significantly improved for the Vibegron group. Voided volume per micturition also increased for the Vibegron group.

Conclusions

The administration of 50 mg of Vibegron once daily for 12 weeks showed significant improvement compared with follow-up without treatment in bladder storage (OAB) symptoms after laser vaporization of the prostate for symptomatic benign prostatic hyperplasia.

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Vibegron 治疗前列腺激光汽化术后残余膀胱过度活动症状的有效性和安全性：单中心前瞻性随机对照试验（VAPOR TRIAL）。

研究目的本研究旨在评估Vibegron治疗前列腺激光汽化术（光选择性前列腺汽化术、接触式前列腺激光汽化术和铥激光汽化术）后残留膀胱过度活动症（OAB）症状的有效性和安全性：这项随机、开放标签、平行组、单中心优效试验（jRCTs071190040）的观察期为12周，招募了年龄在40岁或40岁以上、接受过不少于12周且不超过1年的前列腺激光汽化术的男性OAB患者。患者被分配接受每天一次、每次 50 毫克的 Vibegron 治疗或为期 12 周的无治疗随访：47名患者于2020年1月至2023年3月期间入组。Vibegron组的中位年龄（四分位数间距）为75.5（72.5-78.5）岁，对照组为76.5（71.0-81.0）岁。随机分组 12 周后，24 小时尿频的平均变化（95% 置信区间）的组间差异为-3.66（-4.99，-2.33），Vibegron 组显著下降。Vibegron组的膀胱过度活动症状评分、国际前列腺症状评分、IPSS贮存评分和膀胱过度活动问卷评分均有显著改善。Vibegron组每次排尿量也有所增加：结论：在对有症状的良性前列腺增生症进行前列腺激光汽化术后，与不进行治疗的随访相比，每天服用一次 50 毫克的维贝琼，持续 12 周后，膀胱储尿（OAB）症状有了明显改善。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

LUTS: Lower Urinary Tract Symptoms UROLOGY & NEPHROLOGY-

CiteScore

3.00

自引率

7.70%

发文量

审稿时长

>12 weeks

期刊介绍： LUTS is designed for the timely communication of peer-reviewed studies which provides new clinical and basic science information to physicians and researchers in the field of neurourology, urodynamics and urogynecology. Contributions are reviewed and selected by a group of distinguished referees from around the world, some of whom constitute the journal''s Editorial Board. The journal covers both basic and clinical research on lower urinary tract dysfunctions (LUTD), such as overactive bladder (OAB), detrusor underactivity, benign prostatic hyperplasia (BPH), bladder outlet obstruction (BOO), urinary incontinence, pelvic organ prolapse (POP), painful bladder syndrome (PBS), as well as on other relevant conditions. Case reports are published only if new findings are provided. LUTS is an official journal of the Japanese Continence Society, the Korean Continence Society, and the Taiwanese Continence Society. Submission of papers from all countries are welcome. LUTS has been accepted into Science Citation Index Expanded (SCIE) with a 2011 Impact Factor.