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

NCT ID: NCT00679315

Last Updated: 2013-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-12-31

Brief 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.

Detailed 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

Conditions

Voiding Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Alpha blocker

alfuzosin hydrochloride XL 10mg

Group Type: EXPERIMENTAL

alfuzosin hydrochloride XL 10mg

Intervention Type: DRUG

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Interventions

alfuzosin hydrochloride XL 10mg

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Intervention Type: DRUG

Placebo

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Xatral® XL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Handok Inc.

INDUSTRY

Sponsor Role: collaborator

The Korean Urological Association

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

KYU-SUNG LEE

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyu-Sung Lee, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, Seoul, South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Holy Family Hospital, The Catholic University of Korea

Kyonggi-do, , South Korea

Pusan National University Hospital

Pusan, , South Korea

Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Anam Hospital, College of Medicine, Korea University

Seoul, , South Korea

Kangnam St. Mary's Hospital, The Catholic University of Korea

Seoul, , South Korea

Asan Medical Center, Ulsan College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2007-07-073

Identifier Type: -

Identifier Source: org_study_id