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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2009

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

Intervention(s) in this Clinical Trial

• Drug: alfuzosin hydrochloride XL 10mg
  • One tablet to be taken daily after a meal before bedtime for 8 weeks.
• Drug: Placebo
  • One tablet to be taken daily after a meal before bedtime for 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • alfuzosin hydrochloride XL 10mg
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Actual change in the score of IPSS from baseline to 8 weeks of treatment.
  • Time Frame: 8 weeks of treatment
    Safety Issue?: No

Secondary Measures

• IPSS parameters
  • Time Frame: 4 and 8 weeks of treatment.
    Safety Issue?: No
• BFLUTS-SF parameters
  • Time Frame: 4 and 8 weeks of treatment
    Safety Issue?: No
• Uroflowmetry & PVR parameters
  • Time Frame: 4 and 8 weeks of treatment
    Safety Issue?: No
• Micturition diary parameters
  • Time Frame: 4 and 8 weeks of treatment
    Safety Issue?: No
• Quality of life parameters
  • Time Frame: 4 and 8 weeks of treatment
    Safety Issue?: No
• Patient Perception of Bladder Condition
  • Time Frame: 8 weeks of treatment
    Safety Issue?: No
• Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
  • Time Frame: 8 weeks of treatment
    Safety Issue?: No

Inclusion Criteria:

• Female aged ≥ 18
• Have voiding symptoms as chief complaints over 3 months
• IPSS symptom score ≥ 15
• A peak flow rate <12 mL/sec with a minimum voided volume of 100 mL and/or a postvoid residual urine volume >150 mL
• Underwent pressure-flow study

Exclusion Criteria:

• Patients who meet any of the following criteria are to be excluded from the study:
• Neurogenic voiding dysfunction
• Anatomic causes of bladder outlet obstruction
• Perform physical examination in patients diagnosed as BOO in pressure-flow study by urethral evaluation with 16 Fr urethral sound: if there is resistance to 16Fr sound, it will be diagnosed as anatomical BOO and the patients can not participate in the study.
• Previous surgical procedures related to incontinence or cystocele
• Pregnant or nursing women
• Intake of medications and drugs affecting bladder function: alpha blocker, anticholinergic
• Anticholinergic drugs: Tolterodine, Oxybutynin, Propiverin, Trospium, Solifenacin, SSRI including TCA
• Cholinergic drug: Bethanechol
• Any other blocker other than alfuzosin
• patients can be enrolled after wash-out
• Any positive urine culture had to be successfully treated before the recruitment.
• Clinically significant ( ≥ Stamey grade II/III) stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test.
• Recurrent UTIs defined as having been treated for symptomatic UTIs ≥ 4 times in the last year
• Diagnosed or suspected interstitial cystitis
• Patients with marked cystocele or other clinically significant pelvic prolapse.
• Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with:
• Estrogen treatment started more than 2 months prior to inclusion will be allowed
• Receipt of any electrostimulation or bladder training within the 14 days before randomization, or expected to start such treatment during the study.
• Hypersensitive to the study drug
• Orthotopic hypotension or history of orthotopic hypotension
• Intake of calcium channel blockers
• Severe hepatic or renal dysfunctions

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Samsung Medical Center

Overall Clinical Trial Officials and Contacts

Myung-Soo Choo, Ph.D Principal Investigator Asan Medical Center, Ulsan College of Medicine  

Overall Contact: Kyu-Sung Lee, Ph.D 82-2-3410-3554 ksleedr@skku.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679315

Study ID Number: ALFUS_L_02533

ClinicalTrials.gov Identifier: NCT00679315

Health Authority: South Korea: Korea Food and Drug Administration (KFDA)