Prospective Observational Study to Assess the Safety and Efficacy of Once- Daily Tamcontin ® Tablet (Continus ® Controlled Release Tablet of Tamsulosin Hydrochloride, 0.4 Mg) in the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia (BPH) in the Routine Clinical Practice- An Indian Experience.

To investigate the safety and efficacy of once-daily Tamcontin (R) Tablet (Continus (R) controlled release tablet of tamsulosin hydrochloride, 0.4 mg) in the routine clinical treatment of Benign prostatic hyperplasia (BPH) in India. BPH is a prevalent disease, especially in old men and if left untreated can lead to serious complications such as acute urinary retention, renal insufficiency and failure, urinary tract infection and bladder stones. The impact of BPH on quality of life (QOL) can be significant and cannot be underestimated. A total of 100 newly diagnosed, treatment naive BPH patients were included in the study from 6 urology centres. Patients were assigned to once-daily nighttime treatment with Tamcontin (R) tablet for a period of 6 weeks. Following the baseline visit, patients were examined at week 3 and 6. The efficacy variables of the study were International Prostate Symptom Score (IPSS), quality of life (QOL), maximal urinary flow rate (Qmax), post void residual urine volume and hours of undisturbed sleep (HUS). Safety was assessed via monitoring of adverse events at every visit. The mean age of the patients was 59.6 +/- 10.5 years. There was significant improvement in IPSS, QOL, post void residual urine volume and hours of undisturbed sleep (nocturia) at week 3 and 6. The study drug was well tolerated and no grade 3/4 toxicities were observed. The present study indicates the therapeutic advantage of Continus (R) controlled release tablet of tamsulosin hydrochloride (0.4 mg) in the treatment of BPH in the routine clinical practice.