Efficacy and safety of combined therapy with tamsulosin and tolterodine in female patients with a maximal flow rate less than 12 ml/s.

INTRODUCTION AND HYPOTHESIS: We assessed the effect of tamsulosin HCl (0.2 mg) with or without tolterodine extended release (2 mg) on female patients with a maximal flow rate (Qmax) less than 12 ml/s who were suspected of having functional bladder outlet obstruction.

METHODS

From January 2007 to December 2008, 250 patients with a Qmax less than 12 ml/s were selected for this study. Initial drop-out rates in groups I (15.2%) and II (40.0%) are significantly different: 19 of 125 patients in groups I and 50 of 125 patients in group II failed to complete the 12-week clinical trial. The patients were treated with tamsulosin alone (0.2 mg/day; group I, n = 106) or with tamsulosin combined with tolterodine (2 mg/day; group II, n = 75). The effectiveness of these medications was assessed at baseline and after 12 weeks of treatment on the basis of the International Prostate Symptom Score (IPSS) and other measures including the Qmax and the postvoid residual urine volume.

RESULTS

The total IPSS, the voiding symptom score, the Qmax, and the residual urine volume were significantly improved from baseline after 12 weeks of treatment (p < 0.05) in both groups, whereas the storage symptom score significantly improved only in group II (p < 0.05). After 12 weeks of treatment, there were no significant differences in subjective symptom scores or objective uroflowmetric parameters between the two groups, except for storage symptoms (group I, 4.3 ± 1.6 vs group II, 3.8 ± 0.9) and postvoid residual urine (group I, 31.8 ± 22.4 vs group II, 56.1 ± 29.7), which was not considered to be clinically meaningful.

CONCLUSION

Combination therapy with tamsulosin and tolterodine improved the subjective symptoms and uroflowmetric measures of female patients with a maximal flow rate of less than 12 ml/s. Women with a slight degree of storage symptoms will not be benefitted by prescribing anticholinergics.