Objectives: To determine whether tadalafil, a PDE5i, is effective on stent-associated symptoms. Methods: In this double-blind randomized clinical trial, 80 consecutive male patients with unilateral double J stents were randomly assigned to intervention and placebo groups (n = 40 per group). The patients received 10 mg of tadalafil or placebo once a day for four weeks. The Ureteral Stent Symptom Questionnaire (USSQ) was selected as the primary outcome assessment tool. Complications were recorded as secondary outcomes. Data were analyzed using STATA 11 statistical software. Relative risk (RR) and risk difference (RD) were calculated for appropriately dichotomized endpoints. Results: Of the 80 patients who provided consent, 72 patients successfully completed the study. The mean urinary symptom index score was 30.94 in the placebo group and 26.59 in the tadalafil group (P = 0.0003). Stent-related pain was reported by 80% of the patients in the placebo group and by 67.6% of the patients in the tadalafil group. The mean pain index score was 20.77 in the placebo group and 16.41 in the tadalafil group (P = 0.039). The mean sexual matters score in the placebo and tadalafil groups was 6.20 and 3.73, respectively (P = 0.0007). There was no significant difference in other domains between the groups. The tadalafil group showed no increase in major side effects compared to the placebo group. Conclusions: Tadalafil improved stent-related urinary symptoms, pain, sexual status, and overall score; it can also be used as a novel treatment modality in the alleviation of lower urinary tract symptoms and improve the quality of life in these patients.

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