Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

January 26, 2008 updated by: Tabriz University
The purpose of this study is to determine whether Tamsolusin or Prazosin are effective in the treatment of female voiding dysfunction(BOO)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
taking Tamsulosin
Drug: tamsolusin
0.4 mg /day
Other Names:
  • Flomax
Active Comparator: 2
taking prasosin
Drug: prazosin
1 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient symptoms improvement(Standard questionare)
Time Frame: every month untile 3 months
every month untile 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Urodynamics parameters improvement
Time Frame: three months later
three months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tabriz University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Anticipated)

March 1, 2007

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

January 25, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

January 29, 2008

Last Update Submitted That Met QC Criteria

January 26, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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