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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Collaborators: Handok Inc.; Handok Pharmaceuticals Co., Ltd.; The Korean Urological Association
• Treatments: 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