Efficacy and Safety of Alfuzosin for the Treatment of Voiding Dysfunction in Female - Full Text View

Sponsor:	Samsung Medical Center
Collaborators:	Handok Pharmaceuticals Co., Ltd. The Korean Urological Association
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00679315

Purpose

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.

Condition	Intervention	Phase
Female Voiding Dysfunction	Drug: alfuzosin hydrochloride XL 10mg Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Alfuzosin hydrochloride Alfuzosin

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Actual change in the score of IPSS from baseline to 8 weeks of treatment. [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IPSS parameters [ Time Frame: 4 and 8 weeks of treatment. ] [ Designated as safety issue: No ]
BFLUTS-SF parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
Uroflowmetry & PVR parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
Micturition diary parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
Quality of life parameters [ Time Frame: 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
Patient Perception of Bladder Condition [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]
Benefit, Satisfaction, and Willingness to Continue (BSW) Questions [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	June 2008
Study Completion Date:	December 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Alpha blocker alfuzosin hydrochloride XL 10mg	Drug: alfuzosin hydrochloride XL 10mg One tablet to be taken daily after a meal before bedtime for 8 weeks. Other Name: Xatral® XL
Placebo Comparator: Placebo Placebo	Drug: Placebo One tablet to be taken daily after a meal before bedtime for 8 weeks. Other Name: Placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679315

Locations

Korea, Republic of
Samsung Medical Center
50 Ilwon-Dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710
Chungnam National University Hospital
Daejeon, Korea, Republic of
Holy Family Hospital, The Catholic University of Korea
Kyonggi-do, Korea, Republic of, 420-717
Pusan National University Hospital
Pusan, Korea, Republic of, 602-739
Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University
Seoul, Korea, Republic of, 100-380
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Anam Hospital, College of Medicine, Korea University
Seoul, Korea, Republic of, 136-705

Sponsors and Collaborators

Samsung Medical Center

Handok Pharmaceuticals Co., Ltd.

The Korean Urological Association

Investigators

Principal Investigator:

Kyu-Sung Lee, Ph.D

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00679315 History of Changes
Other Study ID Numbers:	2007-07-073
Study First Received:	May 14, 2008
Last Updated:	May 10, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:

female voiding dysfunction
alpha adrenoreceptor antagonists
IPSS or American Urological Association symptom index

Additional relevant MeSH terms:

Alfuzosin
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists

Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012