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Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

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ClinicalTrials.gov Identifier: NCT00602186
Recruitment Status : Unknown
Verified January 2008 by Tabriz University.
Recruitment status was:  Active, not recruiting
First Posted : January 28, 2008
Last Update Posted : January 29, 2008
Sponsor:
Information provided by:
Tabriz University

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

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Drug: tamsolusin Drug: prazosin Phase 1 Phase 2

Detailed 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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
Study Start Date : July 2005
Estimated Primary Completion Date : March 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
taking Tamsulosin
Drug: tamsolusin
0.4 mg /day
Other Name: Flomax
Active Comparator: 2
taking prasosin
Drug: prazosin
1 mg/day



Primary Outcome Measures :
  1. patient symptoms improvement(Standard questionare) [ Time Frame: every month untile 3 months ]

Secondary Outcome Measures :
  1. Urodynamics parameters improvement [ Time Frame: three months later ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00602186


Sponsors and Collaborators
Tabriz University
Investigators
Study Director: SAKINEH hajebrahimi, MD Urology department ofTabriz University of Medical Sciences

Responsible Party: Lily Nosraty, Tabriz University
ClinicalTrials.gov Identifier: NCT00602186     History of Changes
Other Study ID Numbers: 85-1
First Posted: January 28, 2008    Key Record Dates
Last Update Posted: January 29, 2008
Last Verified: January 2008

Keywords provided by Tabriz University:
female voiding dysfunction
Tamsolusin
prazosin

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Tamsulosin
Prazosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents