Back to resultsEffect 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
About this trial
This is an interventional treatment trial for Neurogenic Bladder focused on measuring female voiding dysfunction, Tamsolusin, prazosin
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
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
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
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