Trial design~Phase II, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the clinical efficacy and safety of alfuzosin (10mg, qd) from baseline to 8 weeks of treatment in female patients with non-neurogenic voiding dysfunction.~Efficacy Assessment~Primary efficacy endpoint~Actual change in the score of IPSS from baseline to 8 weeks of treatment.~Secondary efficacy endpoint~IPSS parameters~Percent change in the score of IPSS from baseline to 4 and 8 weeks of treatment.~Actual and percent changes in the sub-scale of IPSS from baseline to 4 and 8 weeks of treatment~Storage score: sum of questions 2, 4 and 7~Voiding score: sum of questions 1, 3, 5 and 6~Scored form of the Bristol Female Lower Urinary Tract Symptoms (BFLUTS-SF)parameters~Actual and Percent change in BFLUTS-SF from baseline to 4 and 8 weeks of treatment.~Actual and percent changes in the sub-scale of BFLUTS-SF from baseline to 4 and 8 weeks of treatment~BFLUTS-FS: sum scores F1-F4~BFLUTS-VS: sum scores V1-V3~BFLUTS-IS: sum scores I1-I5~BFLUTS-sex: sum scores S1 & S2~Uroflowmetry & PVR parameters~Numeric and percent changes from baseline to 4 and 8 weeks of treatment.~Maximum flow rate (mL/s)~Average flow rate (mL/s)~Post-void residual urine (mL)~Micturition diary parameters~Change in mean number of micturitions per 24 hours at weeks 4 and 8 relative to baseline~Percent change of micturitions per 24 hours at weeks 4 and 8 relative to baseline~Change in mean number of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline~Percent change of nighttime micturitions per 24 hours at weeks 4 and 8 relative to baseline~Change in mean number of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline (Urgency episodes are defined as those with Bladder Sensation Scale rating of ≥ 3 in the diary).~Percent change of urgency episodes per 24 hours at weeks 4 and 8 relative to baseline~Change in the mean and sum rating on the Bladder Sensation Scale at weeks 4 and 8 relative to baseline~Quality of life (QoL) parameters~Change in Bother score of IPSS from baseline to 4 and 8 weeks of treatment.~Change in QOL subscale scores of BFLUTS SF from baseline to 4 and 8 weeks of treatment~BFLUTS-QoL: Sum scores QoL1-QoL5~Patient Perception of Bladder Condition (PPBC)~Change from baseline in PPBC after 8 weeks of double-blind treatment~Benefit, Satisfaction, and Willingness to Continue (BSW) Questions~Patient Perception of Treatment Benefit at week 8~Patient Perception of Treatment Satisfaction at week 8~Willingness to continue with treatment at week 8
The purpose of this study is to explore the efficacy of Alfuzosin (10 mg, qd) in reducing the score of International Prostate Symptom Score (IPSS) from baseline to 8 weeks of treatment in female patients with voiding dysfunction.