Comparison of the Effectiveness of Tamoxifen and Mitomycin C in the Prevention of Recurrent Urethral Stricture Following Internal Optical Urethrotomy (IOU): A Randomized Controlled Trial

Internal optical urethrotomy (IOU) is a common surgical procedure for treating anterior urethral strictures, but recurrence remains a significant concern. The aim of the study is to compare the effectiveness of oral tamoxifen versus mitomycin C (MMC) in preventing recurrence and improving functional outcomes following IOU for anterior urethral stricture. This prospective, randomized controlled trial enrolled 60 male patients with anterior urethral strictures ≤2 cm in length. Participants were randomized 1:1 to receive oral tamoxifen or MMC immediately following IOU. Outcomes assessed at baseline, three months, and six months included the International Prostate Symptom Score (IPSS) as the primary outcome, and secondary measures, including maximum urinary flow rate (Qmax), stricture morphology on retrograde urethrogram, recurrence rate, and recurrence-free period. Recurrence-free period was analyzed separately using Kaplan-Meier analysis. Statistical analysis used the independent-samples t-test, Chi-square test, and Kaplan-Meier analysis, with p <0.05 considered significant. Baseline characteristics were similar between groups. At three months, both groups showed significant improvement in IPSS and Qmax, with no intergroup difference. At six months, tamoxifen patients had significantly lower IPSS (12.33 ± 2.29 vs. 19.23 ± 3.66; p < 0.001), higher Qmax (11.22 ± 1.14 vs. 7.77 ± 0.91 mL/s; p < 0.001), and narrower stricture width (1.76 ± 0.28 vs. 3.07 ± 0.38 mm; p < 0.001) than MMC patients. Recurrence occurred in 23.3% of tamoxifen and 20.0% of MMC patients (p = 0.787). Kaplan-Meier analysis showed no significant difference in recurrence-free period (p > 0.05). Both tamoxifen and MMC improved urinary function after IOU, but tamoxifen provided superior functional improvement at six months, despite similar recurrence rates. These findings support further evaluation of tamoxifen as an adjuvant to IOU in larger, long-term trials.