Overview
Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female
Status:
Completed
Completed
Trial end date:
2009-12-01
2009-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Samsung Medical CenterCollaborators:
Handok Inc.
Handok Pharmaceuticals Co., Ltd.
The Korean Urological AssociationTreatments:
Alfuzosin
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