Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female

Voiding Dysfunction Clinical Trial

Official title: Efficacy and Safety of Alfuzosin for the Treatment of Non-neurogenic Voiding Dysfunction in Female: An 8 Week Prospective, Randomized Double Blind, Placebo-Controlled, Parallel Group Study (Phase Ⅱ)

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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

1. Primary efficacy endpoint

Actual change in the score of IPSS from baseline to 8 weeks of treatment.

2. 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Voiding Dysfunction

• NCT number: NCT00679315
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 2
• Start date: June 2008
• Completion date: December 2009