Urology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.
Urology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
World J Urol. 2022 Oct;40(10):2505-2511. doi: 10.1007/s00345-022-04074-4. Epub 2022 Jul 8.
In this placebo-controlled trial, we aimed to evaluate the clinical results of using PDE-5 inhibitor, tadalafil 5 mg OD, for management of CP/CPPS.
140 patients ≤ 45 years old with moderate/severe CP/CPPS associated with ED (IIEF-5 < 22) were randomly divided and received either tadalafil 5 mg OD (tadalafil-group) or placebo (control-group) for 6 weeks. Post-treatment CPSI scores were compared to baseline and to placebo. Clinically significant responders (≥ 25% reduction from baseline score) were calculated. Tadalafil-induced changes in IIE-5 were evaluated in correlation to that of CPSI scores.
By the 6th week, 59 and 56 patients were available in both groups respectively. Compared to baseline, tadalafil-group patients showed significant improvement in total, pain, urinary and Qol domains of CPSI (19.1 ± 5.26, 10.42 ± 3.55, 4.2 ± 1.72 and 4.47 ± 1.64 vs. 24.21 ± 5.05, 12.14 ± 3.57, 6.08 ± 1.53 and 6.22 ± 1.76), p < 0.5. When compared to placebo, all 6th week CPSI domains scores, except for pain, were significantly better in tadalafil-group (p < 0.05). Post-treatment pain score didn't significantly differ between both groups (10.42 ± 3.55, vs. 11.71 ± 3.9, p > 0.05). Clinically significant responders were 30 patients (50.8%) in tadalafil-group vs. 3 patients (5.4%) in control. Tadalafil-induced changes in IIEF-5 score had weak but significant correlation to Qol domain (r = - 0.28, p < 0.05).
Tadalafil 5 mg OD can significantly improve all CPSI domains as compared to baseline. Post-treatment CPSI scores, except for pain, were better than placebo. About 50.8% of patients can develop ≥ 25% reduction in their total CPSI scores after treatment. Apart from Qol domain, these changes are not significantly correlated to tadalafil-induced IIEF-5 scores changes.
在这项安慰剂对照试验中，我们旨在评估使用 PDE-5 抑制剂他达拉非 5mg，每天一次，治疗 CP/CPPS 的临床结果。
140 名年龄≤45 岁的 CP/CPPS 合并 ED 患者（IIEF-5<22），随机分为他达拉非 5mg 组（他达拉非组）或安慰剂组（对照组），接受治疗 6 周。治疗后与基线和安慰剂比较 CPSI 评分。计算临床显著应答者（与基线评分相比降低≥25%）。评估他达拉非对 IIEF-5 的影响与 CPSI 评分的相关性。
第 6 周时，两组分别有 59 名和 56 名患者可评估。与基线相比，他达拉非组患者的 CPSI 总评分、疼痛评分、排尿评分和生活质量评分均显著改善（19.1±5.26、10.42±3.55、4.2±1.72 和 4.47±1.64 比 24.21±5.05、12.14±3.57、6.08±1.53 和 6.22±1.76，p<0.05）。与安慰剂相比，他达拉非组在第 6 周时的所有 CPSI 评分均显著改善（p<0.05），除疼痛评分外。两组治疗后疼痛评分无显著差异（10.42±3.55，比 11.71±3.9，p>0.05）。他达拉非组的临床显著应答者为 30 例（50.8%），对照组为 3 例（5.4%）。他达拉非对 IIEF-5 评分的影响与生活质量评分呈弱相关（r=-0.28，p<0.05）。
与基线相比，他达拉非 5mg，每天一次可显著改善 CPSI 的所有评分。治疗后，除疼痛评分外，CPSI 评分均优于安慰剂。治疗后约 50.8%的患者的总 CPSI 评分可降低≥25%。除生活质量评分外，这些变化与他达拉非诱导的 IIEF-5 评分变化无显著相关性。
