Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female
- Conditions
- Voiding Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00679315
- Lead Sponsor
- Samsung Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alpha blocker alfuzosin hydrochloride XL 10mg alfuzosin hydrochloride XL 10mg Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Actual change in the score of IPSS from baseline to 8 weeks of treatment. 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method IPSS parameters 4 and 8 weeks of treatment. BFLUTS-SF parameters 4 and 8 weeks of treatment Uroflowmetry & PVR parameters 4 and 8 weeks of treatment Micturition diary parameters 4 and 8 weeks of treatment Quality of life parameters 4 and 8 weeks of treatment Patient Perception of Bladder Condition 8 weeks of treatment Benefit, Satisfaction, and Willingness to Continue (BSW) Questions 8 weeks of treatment
Trial Locations
- Locations (9)
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Holy Family Hospital, The Catholic University of Korea
🇰🇷Kyonggi-do, Korea, Republic of
Anam Hospital, College of Medicine, Korea University
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
🇰🇷Seoul, Korea, Republic of
Kangnam St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
Asan Medical Center, Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of