The efficacy and safety of oral Tamsulosin controlled absorption system (OCAS) for the treatment of lower urinary tract symptoms due to bladder outlet obstruction associated with benign prostatic hyperplasia: an open-label preliminary study

Abstract

Aims: Tamsulosin, a superselective subtype alpha 1a and 1d blocker, is used for the treatment of male Lower Urinary Tract Symptoms (LUTS) commonly caused by Benign Prostatic Hyperplasia (BPH). This prospective study evaluated the efficacy and safety of a new formulation, Tamsulosin OCAS® (Oral Controlled Absorption System), for LUTS associated with BPH in Thai patients. Materials and Methods: Fifty one patients over 40 years old with complaints of LUTS associated with BPH were recruited. Patients received an 8 week course of once daily 0.4 mg tamsulosin OCAS®, and were followed up at 2 (visit 3), 4 (visit 4) and 8 (visit 5) weeks post-treatment. At each visit, patients were assessed using the International Prostate Symptom Score (IPSS), Nocturia Quality of Life (N-QoL) Questionnaire, QoL Assessment Index (IPSS-QoL), and International Index of Erectile Function (IIEF). The primary outcome was efficacy of Tamsulosin. The secondary outcomes included change in the mean number of nocturia episodes, hours of undisturbed sleep (HUS) and uroflowmetry measurements. Results: Total IPSS significantly decreased at week 8 from baseline (from 19.52 to 6.08; p < 0.001). Similarly, the voiding and storage subscores of IPSS also continued to improve significantly starting from the second and third visits, respectively (p < 0.001 versus baseline). The IPSS-QoL and N-QoL scores significantly improved at visit 3 through end of study. In addition, we observed significant nocturia and HUS improvement in their last clinic visit. Uroflowmetry parameters, Q max and Q ave , improved significantly at 3 rd clinic visit . Three patients experienced mild dizziness. Conclusion: Tamsulosin OCAS® treatment led to significant improvements in LUTS, HUS and QoL in Thai patients with bladder outlet obstruction from BPH with few side effects.

Comparative Assessment of Efficacy of Tadalafil and Tamsulosin Alone and in Combination Among Men With Benign Prostatic Hyperplasia

“…However, literature review revealed that no study has evaluated the effect of each of these drugs with their combination in the selected population and geographic area. [6][7][8][9][10] In other monotherapy studies with these drugs, it was reported that the IPSS results were in line with results of the present study. Double-blind, randomized, placebo-controlled studies of 5 mg tadalafil once-daily in Japanese men, Japanese, Korean and Taiwanese men and Japanese and Korean men has demonstrated greater improvement in the change from baseline to endpoint in total IPSS for monotherapy with 5 mg tadalafil compared to placebo.…”

An open-label, prospective interventional study of the tolerability and efficacy of 0.4 mg oral tamsulosin oral controlled absorption system in men with lower urinary tract symptoms associated with benign prostatic hyperplasia who are unsatisfied with treatment with 0.2 mg tamsulosin

“… 14 In a study of 51 Thai men with LUTS associated with BPH, 0.4 mg tamsulosin OCAS was given for 8 weeks, with significant improvements in total IPSS scores, voiding and storage, QOL, and nocturia, as well as sleep and uroflowmetry parameters, although some mild dizziness was reported. 15 Although 0.2 mg tamsulosin has been routinely used, results of these studies may allay the concerns of medical practitioners in Taiwan and encourage them to switch to a higher 0.4 mg dose for improved efficacy and the support of an acceptable safety and tolerability profile.…”

The New England Research Institutes, Inc. (NERI) Nocturia Advisory Conference 2012: focus on outcomes of therapy

“…not ‘blinded’, uncontrolled), it does suggest that specific nocturia outcomes might by positively affected by some primary BPE therapies, primarily 5ARIs, botulinum toxin‐A, and TURP. In contrast, and as summarised in Table , available evidence suggests only modest efficacy for α‐adrenergic antagonists and NSAIDs. Continuing research in these areas will be improved only if more specific and validated nocturia outcome measures are incorporated into study methodologies.…”