Efficacy and safety evaluation of imidafenacin administered twice daily for continency recovery following radical prostatectomy in prostate cancer patients: Prospective open-label case-controlled randomized trial.

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2024-09-01 DOI:10.4111/icu.20240129
Jun Hee Lee, Hyeok Jun Goh, Kisoo Lee, Dong Won Choi, Kwang Min Lee, Soodong Kim
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Abstract

Purpose: This study aims to prospectively analyze the effects of anticholinergic therapy using imidafenacin on detrusor overactivity occurring after robot-assisted radical prostatectomy (RARP).

Materials and methods: Patients were followed-up at outpatient visits 2-4 weeks post-surgery (visit 2) to confirm the presence of urinary incontinence. Those confirmed with urinary incontinence were randomly assigned in a 1:1 ratio to the anticholinergic medication group (imidafenacin 0.1 mg twice daily) or the control group. Patients were followed-up at 1, 3, and 6 months post-surgery for observational assessments, including the International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS).

Results: A total of 49 patients (25 in the treatment group and 24 in the control group) were randomized for the study. There were no differences observed between the groups in terms of age, comorbidities, prostate size, or pathological staging. According to the IPSS questionnaire results, there was no statistically significant difference between the medication and control groups (p=0.161). However, when comparing storage and voiding symptoms separately, there was a statistically significant improvement in storage symptom scores (p=0.012). OABSS also revealed statistically significant improvement in symptoms from 3 months post-surgery (p=0.005), which persisted until 6 months post-surgery (IPSS storage: p=0.023, OABSS: p=0.013).

Conclusions: In the case of urinary incontinence that occurs after RARP, even if the function of the intrinsic sphincter is sufficiently preserved, if urinary incontinence persists due to changes in the bladder, pharmacological therapy using imidafenacin can be beneficial in managing urinary incontinence.

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前列腺癌患者根治性前列腺切除术后,每日两次服用咪达那新促进尿失禁恢复的有效性和安全性评估:前瞻性开放标签病例对照随机试验。
目的:本研究旨在前瞻性地分析使用咪达那新进行抗胆碱能治疗对机器人辅助前列腺癌根治术(RARP)后发生的逼尿肌过度活动的影响:患者在手术后 2-4 周(第 2 次就诊)接受门诊随访,以确认是否存在尿失禁。确认有尿失禁的患者按 1:1 的比例随机分配到抗胆碱能药物组(咪达那新 0.1 毫克,每天两次)或对照组。术后1、3和6个月对患者进行随访,进行观察评估,包括国际前列腺症状评分(IPSS)和膀胱过度活动症状评分(OABSS):共有 49 名患者(治疗组 25 人,对照组 24 人)被随机纳入研究。两组患者在年龄、合并症、前列腺大小或病理分期方面均无差异。根据 IPSS 问卷调查结果,药物治疗组和对照组之间没有统计学差异(P=0.161)。不过,如果分别比较储尿症状和排尿症状,储尿症状得分有统计学意义的显著改善(P=0.012)。OABSS也显示,从术后3个月起,症状有了统计学意义上的明显改善(p=0.005),这种改善一直持续到术后6个月(IPSS储尿:p=0.023,OABSS:p=0.013):结论:在RARP术后出现尿失禁的情况下,即使内在括约肌的功能得到了充分的保留,如果由于膀胱的变化而导致尿失禁持续存在,使用咪达那新进行药物治疗对控制尿失禁是有益的。
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来源期刊
ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
自引率
2.10%
发文量
464
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