Efficacy of Tadalafil on Ureteral Stent Symptoms: A Randomized Controlled Trial
Abstract
Objectives: To determine whether tadalafil, a PDE5i, is effective on stent-associated symptoms. Methods: Inthisdouble-blindrandomizedclinicaltrial,80consecutivemalepatientswithunilateraldoubleJstentswererandomly assigned to intervention and placebo groups (n = 40 per group). The patients received 10 mg of tadalafil or placebo once a day for fourweeks. TheUreteralStentSymptomQuestionnaire(USSQ)wasselectedastheprimaryoutcomeassessmenttool. 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 patientsintheplacebogroupandby67.6% of thepatientsinthetadalafilgroup. Themeanpainindexscorewas20.77intheplacebo 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). Therewasnosignificantdifferenceinotherdomainsbetweenthegroups. Thetadalafilgroupshowed no increase in major side effects compared to the placebo group. Conclusions: Tadalafilimprovedstent-relatedurinarysymptoms,pain,sexualstatus,andoverallscore;itcanalsobeusedasanovel treatment modality in the alleviation of lower urinary tract…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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