search
Back to results

Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

Primary Purpose

Neurogenic Bladder

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
tamsolusin
prazosin
Sponsored by
Tabriz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bladder focused on measuring female voiding dysfunction, Tamsolusin, prazosin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    taking Tamsulosin

    taking prasosin

    Outcomes

    Primary Outcome Measures

    patient symptoms improvement(Standard questionare)

    Secondary Outcome Measures

    Urodynamics parameters improvement

    Full Information

    First Posted
    April 18, 2007
    Last Updated
    January 26, 2008
    Sponsor
    Tabriz University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00602186
    Brief Title
    Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
    Official Title
    Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    March 2007 (Anticipated)
    Study Completion Date
    March 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tabriz University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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)
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurogenic Bladder
    Keywords
    female voiding dysfunction, Tamsolusin, prazosin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    taking Tamsulosin
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    taking prasosin
    Intervention Type
    Drug
    Intervention Name(s)
    tamsolusin
    Other Intervention Name(s)
    Flomax
    Intervention Description
    0.4 mg /day
    Intervention Type
    Drug
    Intervention Name(s)
    prazosin
    Intervention Description
    1 mg/day
    Primary Outcome Measure Information:
    Title
    patient symptoms improvement(Standard questionare)
    Time Frame
    every month untile 3 months
    Secondary Outcome Measure Information:
    Title
    Urodynamics parameters improvement
    Time Frame
    three months later

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    SAKINEH hajebrahimi, MD
    Organizational Affiliation
    Urology department ofTabriz University of Medical Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Tamsulosin vs Prazosin in Treatment of Female Voiding Dysfunction

    We'll reach out to this number within 24 hrs