Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding...

Date First Received: April 18, 2007

Last Updated: January 26, 2008

Verified by: Tabriz University, January 2008

Clinical Trial Phase: Phase 1/Phase 2 | Start Date: July 2005

Overall Status: Active, not recruiting

Estimated Enrollment: 80

Brief Summary

Official Title: “Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction”

Condition Keyword(s):

Intervention(s):

The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2007

Detailed Clinical Trial Description

Voiding dysfunction is not uncommon in Tabriz.About 20% of patients in female urology clinic of Tabriz university of medical sciences sufered from some degrees of voiding dysfunction (due to bladder imparement or bladder outlet obstruction).There is limited information about medical treatment of those patients. On the other hand alpha adrenergic blockers are the first choice medication in BENIGN PROSTATIC HYPERPLASIA. There is some new facts about destribution of alpha adrenergic blockers in female pelvic floor.The purpose of this study is to comparision whether Tamsolusin 0.4/daily or Prazosin 1 mg/daily are effective in the treatment of female voiding dysfunction(BOO)

Intervention(s) in this Clinical Trial

  • Drug: tamsolusin
    • 0.4 mg /day
  • Drug: prazosin
    • 1 mg/day

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • taking Tamsulosin
  • Active Comparator: 2
    • taking prasosin

Outcome Measures for this Clinical Trial

Primary Measures

  • patient symptoms improvement(Standard questionare)
    • Time Frame: every month untile 3 months
      Safety Issue?: Yes

Secondary Measures

  • Urodynamics parameters improvement
    • Time Frame: three months later
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Healthy females with voiding difficulty with MFR<12 and post void residual urine>50cc

Exclusion Criteria:

  • History of pelvic floor surgury during last 3 month
  • Any contraindication for Tamsolusin or prazosin

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Tabriz University

Overall Clinical Trial Officials and Contacts

SAKINEH hajebrahimi, MD Study Director Urology department ofTabriz University of Medical Sciences  

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00602186

Study ID Number: 85-1

ClinicalTrials.gov Identifier: NCT00602186

Health Authority: United States: Institutional Review Board

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