Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction - Full Text View

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:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

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
1: Experimental taking Tamsulosin	Drug: tamsolusin 0.4 mg /day
2: Active Comparator 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:	Tabriz University ( Lily Nosraty )
Study ID Numbers:	85-1
Study First Received:	April 18, 2007
Last Updated:	January 26, 2008
ClinicalTrials.gov Identifier:	NCT00602186 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Tabriz University:

female voiding dysfunction
Tamsolusin
prazosin

Additional relevant MeSH terms:

Urinary Bladder, Neurogenic
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Nervous System Diseases
Urinary Bladder Diseases
Cardiovascular Agents
Adrenergic alpha-Antagonists
Antihypertensive Agents

Pharmacologic Actions
Nerve Compression Syndromes
Signs and Symptoms
Urologic Diseases
Neuromuscular Diseases
Prazosin
Therapeutic Uses
Peripheral Nervous System Diseases
Tamsulosin
Neurologic Manifestations
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010