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

This study has been completed.
Sponsor:
Collaborators:
Handok Pharmaceuticals Co., Ltd.
The Korean Urological Association
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00679315
First received: May 14, 2008
Last updated: June 7, 2013
Last verified: June 2013
  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
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:


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 ]

Enrollment: 190
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
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
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Anam Hospital, College of Medicine, Korea University
Seoul, Korea, Republic of, 136-705
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of, 138-736
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
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: June 7, 2013
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
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014