A randomized controlled trial evaluating sildenafil citrate in relieving ureteral stent-related symptoms.

PURPOSE: To evaluate the role of sildenafil in relieving ureteral stent symptoms. PATIENTS AND METHODS: A randomized controlled trial was conducted between March 2014 and November 2016. It included adult men who underwent unilateral ureteric stent after ureteroscopy. Patients who were taking PDE5-Is, alpha-blockers or anticholinergics, had contraindication to sildenafil or developed postoperative complications were not included. Eligible patients were randomized using sealed closed envelops to one of two groups (S and C). Patients in group S received sildenafil citrate 50 mg tablet once daily. Patients in group C were the control. All patients answered the ureteral stent symptom questionnaire (USSQ) after 2 weeks of stenting. Primary outcome was the difference in total USSQ score between both groups. Secondary outcomes were tolerability of the treatment and the difference in each domain of USSQ score.
RESULTS: After randomization, four patients (7.3%) in group C withdraw their consent because of severe symptoms and two patients (3.6%) in group S discontinued treatment because of headache and dizziness. Final analysis was performed for 46 and 48 patients in groups C and S, respectively. Total USSQ score and all domains (except work performance) were significantly lower in group S (P < 0.001). Dysuria and urgency were significantly more in group C (P = 0.012 and 0.007, respectively). Three patients in groups S (6.25%) experienced transient mild adverse effects (dyspepsia, flushing and rhinitis in one patient for each) but they continued sildenafil.
CONCLUSIONS: Sildenafil is an effective and well-tolerated treatment option for relieving ureteral stent-related symptoms in men. CLINICALTRIAL. GOV IDENTIFIER: NCT02345980.

RCT Entities:   Population Interventions Outcomes