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他达拉非5毫克对前列腺经尿道切除术后勃起及下尿路持续性储尿期症状的影响:一项随机对照研究。

The effect of tadalafil 5 mg on erection and persistent storage lower urinary tract symptoms after transurethral resection of prostate: a randomized controlled study.

作者信息

Taha Diaa-Eldin, Nabeeh Hossam, Zeinelabden Khaled Magdy, Abdelhalim Elsayed, Elmekawy Salah, Samaha Ibrahem Ismail, Behiry Ahmed, Elmoaty Ahmed Abd, Abdelbaky Tarek, Ibrahim Ali

机构信息

Department of Urology, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh University Hospital, El-Giesh Street, Kafrelsheikh, 33155, Egypt.

Department of Urology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

出版信息

Basic Clin Androl. 2025 Jul 1;35(1):27. doi: 10.1186/s12610-025-00273-2.

Abstract

BACKGROUND

We conducted a double-blind, randomized controlled trial to evaluate the effect of early administration of tadalafil (5 mg once daily) on persistent storage lower urinary tract symptoms (LUTS) and erectile function following transurethral resection of the prostate (TURP). All enrolled patients underwent TURP and were randomly assigned to one of two groups: Group A received tadalafil (5 mg once daily) postoperatively, while Group B received a placebo. Erectile function was assessed using the International Index of Erectile Function-5 (IIEF-5) questionnaire, and LUTS were evaluated using the International Prostate Symptom Score (IPSS). The study was conducted at a tertiary care hospital between May 2021 and October 2022.

RESULTS

A total of 195 patients were enrolled and randomized into two groups: Group A (n = 103), which received tadalafil 5 mg once daily, and Group B (n = 92), which received a placebo. The mean ± standard deviation (SD) scores for the International Index of Erectile Function (IIEF-5) in Group A at 1, 3, and 6 months post-TURP were 11.59 ± 1.90, 19.80 ± 1.12, and 20.97 ± 0.72, respectively. In Group B, the corresponding scores were 4.88 ± 0.82, 12.86 ± 1.56, and 15.32 ± 1.28. These differences were statistically significant (P < 0.001). Similarly, the mean ± SD values for the International Prostate Symptom Score (IPSS) in Group A at 1, 3, and 6 months post-TURP were 7.31 ± 1.66, 4.46 ± 0.97, and 2.33 ± 0.69, respectively, compared to 9.62 ± 3.34, 5.40 ± 1.98, and 2.83 ± 1.27 in Group B (P < 0.001). Regarding storage symptom subscores, Group A demonstrated preoperative and postoperative mean ± SD values of 8.63 ± 1.82, 3.05 ± 0.78, 1.63 ± 0.49, and 0.92 ± 0.67 at preoperative, 1, 3, and 6 months, respectively. In contrast, Group B showed corresponding values of 3.22 ± 0.72, 2.48 ± 0.50, and 1.69 ± 0.47. These differences were also statistically significant (P < 0.001).

CONCLUSION

Tadalafil 5 mg daily as monotherapy following TURP can lead to early improvement in erectile function; however, its effect on persistent storage lower urinary tract symptoms (LUTS) post-TURP appears to be modest.

TRIAL REGISTRATION

Our study has been approved by local ethical committee Kafrelsheikh university(MKSU50-3-1) on 20/5/2021 and by clinical trials (NCT06788704) on 25/1/2025.

摘要

背景

我们开展了一项双盲随机对照试验,以评估早期服用他达拉非(每日 5 毫克)对前列腺经尿道切除术(TURP)后持续性储尿期下尿路症状(LUTS)和勃起功能的影响。所有入组患者均接受了 TURP,并被随机分为两组:A 组术后接受他达拉非(每日 5 毫克),而 B 组接受安慰剂。使用国际勃起功能指数-5(IIEF-5)问卷评估勃起功能,使用国际前列腺症状评分(IPSS)评估 LUTS。该研究于 2021 年 5 月至 2022 年 10 月在一家三级护理医院进行。

结果

共 195 例患者入组并随机分为两组:A 组(n = 103)每日接受 5 毫克他达拉非,B 组(n = 92)接受安慰剂。TURP 术后 1、3 和 6 个月时,A 组国际勃起功能指数(IIEF-5)的平均±标准差(SD)评分分别为 11.59±1.90、19.80±1.12 和 20.97±0.72。B 组的相应评分为 4.88±0.82、12.86±1.56 和 15.32±1.28。这些差异具有统计学意义(P < 0.001)。同样,TURP 术后 1、3 和 6 个月时,A 组国际前列腺症状评分(IPSS)的平均±SD 值分别为 7.31±1.66、4.46±0.97 和 2.33±0.69,而 B 组分别为 9.62±3.34、5.40±1.98 和 2.83±1.27(P < 0.001)。关于储尿期症状子评分,A 组术前、术后 1、3 和 6 个月的平均±SD 值分别为 8.63±1.82、3.05±0.78、1.63±0.49 和 0.92±0.67。相比之下,B 组的相应值为 3.22±0.72、2.48±0.50 和 1.69±0.47。这些差异也具有统计学意义(P < 0.001)。

结论

TURP 后每日服用 5 毫克他达拉非单药治疗可使勃起功能早期改善;然而,其对 TURP 后持续性储尿期下尿路症状(LUTS)的影响似乎不大。

试验注册

我们的研究于 2021 年 5 月 20 日获得当地伦理委员会卡夫勒谢赫大学(MKSU50 - 3 - 1)批准,并于 2025 年 1 月 25 日获得临床试验(NCT06788704)批准。

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