Clinical trial NCT00679315: Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Voiding Dysfunction
Keywords: female voiding dysfunction
alpha adrenoreceptor antagonists
IPSS or American Urological Association symptom index
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Handok Inc.
name: The Korean Urological Association
First posted: 2008-05-16
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Actual change in the score of IPSS from baseline to 8 weeks of treatment.
timeFrame: 8 weeks of treatment
Secondary outcomes:
measure: IPSS parameters
timeFrame: 4 and 8 weeks of treatment.
measure: BFLUTS-SF parameters
timeFrame: 4 and 8 weeks of treatment
measure: Uroflowmetry & PVR parameters
timeFrame: 4 and 8 weeks of treatment
measure: Micturition diary parameters
timeFrame: 4 and 8 weeks of treatment
measure: Quality of life parameters
timeFrame: 4 and 8 weeks of treatment
measure: Patient Perception of Bladder Condition
timeFrame: 8 weeks of treatment
measure: Benefit, Satisfaction, and Willingness to Continue (BSW) Questions
timeFrame: 8 weeks of treatment
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Kyonggi-do
country: Korea, Republic of
facility: Holy Family Hospital, The Catholic University of Korea
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Anam Hospital, College of Medicine, Korea University
city: Seoul
country: Korea, Republic of
facility: Kangnam St. Mary's Hospital, The Catholic University of Korea
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Ulsan College of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: