Status:
COMPLETED
Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Handok Inc.
The Korean Urological Association
Conditions:
Voiding Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 patie...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00679315
Start Date
June 1 2008
End Date
December 1 2009
Last Update
June 10 2013
Active Locations (9)
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1
Samsung Medical Center
Seoul, Seoul, South Korea, 135-710
2
Chungnam National University Hospital
Daejeon, South Korea
3
Holy Family Hospital, The Catholic University of Korea
Kyonggi-do, South Korea, 420-717
4
Pusan National University Hospital
Pusan, South Korea, 602-739