Effect of Tamsulosin vs Prazosin in Treatment of Female V... | NCT00602186

Studies
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

NCT00602186

Sponsor

Tabriz University

Status

Unknown status

Last Update Posted

Jan 29, 2008Estimated

Enrollment

80Actual

Phase

Phase 1Phase 2

Conditions

Neurogenic Bladder

Interventions

tamsolusin
prazosin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Mar 2007Estimated

Completion Date

Mar 2008Estimated

First Submitted Date

Apr 18, 2007

First Submission Date that Met QC Criteria

Jan 25, 2008

First Posted Date

Jan 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2008

Last Update Posted Date

Jan 29, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	taking Tamsulosin	Drug: tamsolusin
2	Active Comparator	taking prasosin	Drug: prazosin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tamsolusin	Drug	0.4 mg /day	1	Flomax

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Urodynamics parameters improvement		three months later

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001750	Urinary Bladder, Neurogenic

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077409	Tamsulosin
D011224	Prazosin

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided