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Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Sponsor
Tabriz University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00602186
Collaborator
(none)
80
Enrollment
2
Arms
32
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
Study Start Date :
Jul 1, 2005
Anticipated Primary Completion Date :
Mar 1, 2007
Anticipated Study Completion Date :
Mar 1, 2008

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. patient symptoms improvement(Standard questionare) [every month untile 3 months]

    Secondary Outcome Measures

    1. Urodynamics parameters improvement [three months later]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Tabriz University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00602186
    Other Study ID Numbers:
    • 85-1
    First Posted:
    Jan 28, 2008
    Last Update Posted:
    Jan 29, 2008
    Last Verified:
    Jan 1, 2008
    Keywords provided by , ,
    female voiding dysfunction
    Tamsolusin
    prazosin
    Additional relevant MeSH terms:
    Urinary Bladder, Neurogenic
    Prazosin

    Study Results

    No Results Posted as of Jan 29, 2008