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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00602186
Other study ID # 85-1
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received April 18, 2007
Last updated January 26, 2008
Start date July 2005
Est. completion date March 2008

Study information

Verified date January 2008
Source Tabriz University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 80
Est. completion date March 2008
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
tamsolusin
0.4 mg /day
prazosin
1 mg/day

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tabriz University

Outcome

Type Measure Description Time frame Safety issue
Primary patient symptoms improvement(Standard questionare) every month untile 3 months Yes
Secondary Urodynamics parameters improvement three months later Yes
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