NCT00679315

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 patients with voiding dysfunction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2008

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

9 months

First QC Date

May 14, 2008

Last Update Submit

June 7, 2013

Conditions

Voiding Dysfunction

Keywords

female voiding dysfunctionalpha adrenoreceptor antagonistsIPSS or American Urological Association symptom index

Outcome Measures

Primary Outcomes (1)

  • Actual change in the score of IPSS from baseline to 8 weeks of treatment.

    8 weeks of treatment

Secondary Outcomes (7)

  • IPSS parameters

    4 and 8 weeks of treatment.

  • BFLUTS-SF parameters

    4 and 8 weeks of treatment

  • Uroflowmetry & PVR parameters

    4 and 8 weeks of treatment

  • Micturition diary parameters

    4 and 8 weeks of treatment

  • Quality of life parameters

    4 and 8 weeks of treatment

  • +2 more secondary outcomes

Study Arms (2)

Alpha blocker

EXPERIMENTAL

alfuzosin hydrochloride XL 10mg

Drug: alfuzosin hydrochloride XL 10mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

alfuzosin hydrochloride XL 10mgDRUG

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Also known as: Xatral® XL
Alpha blocker
PlaceboDRUG

One tablet to be taken daily after a meal before bedtime for 8 weeks.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Holy Family Hospital, The Catholic University of Korea

Kyonggi-do, 420-717, South Korea

Location

Pusan National University Hospital

Pusan, 602-739, South Korea

Location

Cheil General Hospital & Women's Healthcare Center, College of Medicine, Kwandong University

Seoul, 100-380, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Anam Hospital, College of Medicine, Korea University

Seoul, 136-705, South Korea

Location

Kangnam St. Mary's Hospital, The Catholic University of Korea

Seoul, 137-701, South Korea

Location

Asan Medical Center, Ulsan College of Medicine

Seoul, 138-736, South Korea

Location

MeSH Terms

Interventions

alfuzosin

Study Officials

  • Kyu-Sung Lee, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2008

First Posted

May 16, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2009

Study Completion

December 1, 2009

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

KR(9)