MP24-17: Tamsulosin versus tadalafil for management of symptomatic benign prostatic enlargement: assessment of treatment discontinuation rate and symptoms improvement
Introduction: both tamsulosin and tadalafil 5mg are used for treatment of symptomatic benign prostatic enlargement. Nevertheless, the incidence and causes of treatment discontinuation (TD) was not evaluated. A randomized trial is conducted to compare TD rate and symptoms improvement between the two drugs. Methods: A randomized controlled trial (RCT) is conducted with estimate sample size of 160 cases. Sexually active LUTS/BPO patients with concomitant ED were included and randomly allocated in two groups: the first received tadalafil 5mg once daily and the second one received tamsulosin for twelve months. The therapeutic outcomes are assessed at 2weeks , 4weeks , 12weeks, 6 months and 12 months. The evaluation includes International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-15) questionnaire, quality of life (QoL), uroflowmetry, post voiding residual (PVR) and incidence and causes of (TD). Results: In tadalafil group 5 patients lost follow up. thirty out of 80 patients showed drug discontinuation (37.5%), 6 of them developed adverse effects in view of headache and musculoskeletal pain, other 24 patients developed no response. IPSS, QoL & IIEF-15 improved in 12 months follow-up compared to baseline criteria (Table 1) In tamsulosin group, 7 patients lost follow up. Eighteen out of 80 patients showed drug discontinuation (22.5%), 5 of them developed adverse effects in view of dizziness and orthostatic hypotension, while 13 patients showed no response. IPSS ,QoL & Qmax improved in 12 months follow-up compared to baseline criteria. (Table 1) Conclusions: When both groups were compared, discontinuation was higher in tadalafil group due to lack of response with significant statistical difference with comparable adverse events. IPSS & QoL were improved in both drugs. SOURCE OF Funding: mansoura urology and nephrology center (UNC)
