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Introduction and Objectives: Women with overactive bladder and other lower urinary tract symptoms (LUTS) may not improve through monotherapy with antimuscarinic agents or alpha-blockers. To evaluate the efficacy and safety of tamsulosin and tamsulosin plus tolterodine in women with lower urinary tract symptoms, we assessed changes of international prostate symptom scores (IPSS), bladder diary variables, and safety and tolerability following 2 different treatments.
Methods: A randomized, multicenter trial at 4 urology centers involving women over 18 years or older who had a total IPSS of 8 or higher and a bladder diary documenting micturition frequency (8 times per 24 hours), urgency (> 1 episode per 24 hours), and nocturia ((2 episodes). Additional inclusion criteria were maximal urinary flow rate (Qmax, 15 ml per second) with postvoid residual urine (PVR, < 50 ml). Patients were randomly assigned to receive tamsulosin (0.2 mg, N = 40) or both tamsulosin (0.2 mg) plus tolterodine (2 mg, N = 40) for 12 weeks.
Results: IPSS decreased significantly in both groups. IPSS at baseline, at week 4, at week 8, and at week 12 was 23.33, 17.00, 16.50, 12.17 in tamsulosin group and 23.20, 18.20, 17.60, 15.00 in tamsulosin plus tolterodine group, respectively. Qmax at baseline and at week 12 was 11.90 ml/sec and 19.38 ml/sec in the tamsulosin group and 10.44 ml/sec and 20.72 ml/sec in the tamsulosin plus tolterodine group. At week 12, PVR was increased from 7.67 ml to 17.67 ml in the tamsulosin group and from 10.60 ml to 13.20 ml in the tamsulosin plus tolterodine group. Likewise, other diary variables such as urgency, frequency, nocturia, quality of life (QoL), PPBC, and OAB-q were also markedly improved in both groups by week 12. However, there were no significant differences in the changes of these variables between 2 groups.
Conclusions: Although there were no significant differences between the 2 groups, both tamsulosin monotherapy and treatment with tamsulosin plus tolterodine improved IPSS, QoL, Qmax, and PVR in women with LUTS.
KEYWORDS: LUTS, Women