Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS

This randomized, crossover clinical trial evaluated the efficacy and safety of tadalafil compared with darifenacin in managing lower urinary tract symptoms (LUTS) and pain related to indwelling ureteric stents. A total of 150 patients who underwent ureteric stent insertion after endoscopic treatment of ureteric stones were enrolled. Patients were randomized into two groups: Group 1 received tadalafil 5 mg once daily for 3 weeks, followed by a 1-week washout, then darifenacin 7.5 mg once daily for 3 weeks. Group 2 received the reverse sequence. The primary outcome was change in LUTS as measured by a shortened International Prostate Symptom Score (IPSS). The secondary outcome was stent-related pain measured by the Numeric Pain Rating Scale (NPRS). Drug safety and tolerability were also assessed.

NCT Number	NCT07206706
Lead Sponsor	Ain Shams University
Conditions	Management of Ureteric Stent Related LUTS and Pain
Enrollment	150 participants
Start Date	2022-05-01
Primary Completion	2022-12-14 (estimated)
Study Completion	2022-12-28 (estimated)
Updated on ClinicalTrials.gov	2026-01-16