Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2008 by Tabriz University. Recruitment status was Active, not recruiting

First Received on April 18, 2007. Last Updated on January 26, 2008 History of Changes

Sponsor:	Tabriz University
Information provided by:	Tabriz University
ClinicalTrials.gov Identifier:	NCT00602186

Purpose

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

Condition	Intervention	Phase
Neurogenic Bladder	Drug: tamsolusin Drug: prazosin	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

Drug Information available for: Prazosin Prazosin hydrochloride Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Further study details as provided by Tabriz University:

Primary Outcome Measures:

patient symptoms improvement(Standard questionare) [ Time Frame: every month untile 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Urodynamics parameters improvement [ Time Frame: three months later ] [ Designated as safety issue: Yes ]

Enrollment:	80
Study Start Date:	July 2005
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 taking Tamsulosin	Drug: tamsolusin 0.4 mg /day Other Name: Flomax
Active Comparator: 2 taking prasosin	Drug: prazosin 1 mg/day

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)

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602186

Sponsors and Collaborators

Tabriz University

Investigators

Study Director:

SAKINEH hajebrahimi, MD

Urology department ofTabriz University of Medical Sciences

More Information

No publications provided

Responsible Party:	Lily Nosraty, Tabriz University
ClinicalTrials.gov Identifier:	NCT00602186 History of Changes
Other Study ID Numbers:	85-1
Study First Received:	April 18, 2007
Last Updated:	January 26, 2008
Health Authority:	United States: Institutional Review Board

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
Prazosin
Tamsulosin
Antihypertensive Agents
Cardiovascular Agents

Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012