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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
PDE5 inhibitor
anti muscarinic
Ain Shams University Hospita
Cairo, Cairo Governorate, Egypt
change in stent related lower urinary tract symptoms (LUTS)
Change from baseline in stent-related symptoms, measured by a shortened International Prostate Symptom Score (IPSS), including incomplete emptying (Q1) and storage domain (Q2, Q4, Q7). The score was calculated (minimum 0 and maximum 20) according to patients' answers to the questions Higher scores indicate worse symptoms.
Time frame: 3 weeks
Change in numerical Pain rating score (NPRS)
Change from baseline in ureteric stent-related pain, measured by the Numeric Pain Rating Scale (0 = no pain, 10 = worst pain).
Time frame: 3 weeks
Incidence of Adverse Events
Number and type of drug-related adverse events (e.g., dry mouth, constipation, headache, flushing, myalgia), recorded during each treatment phase.
Time frame: Throughout the 7-week study period (3 weeks first drug, 1 week washout, 3 weeks second drug)
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