Back to resultsSingle Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
Primary Purpose
Prostatic Neoplasms, Prostate Disease, Prostate Obstruction
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Tamsulosin, Prostate
Eligibility Criteria
Inclusion Criteria: age more than 50 years moderate to severe lower urinary tract symptoms Exclusion Criteria: prostatic cancer urethral stricture prostate surgery Neurogenic bladder
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mg
Arm Description
Single dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mg
Outcomes
Primary Outcome Measures
Change in the lower urinary tract symptoms
Assessed by the improvement in the internal prostatic symptoms score (IPSS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05834270
Brief Title
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
Official Title
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Menoufia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single dose versus double dose tamsulosin in Management of Moderate and severe lower urinary tract symptoms due to benign prostatic hyperplasia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Disease, Prostate Obstruction, Prostate Hypertrophy
Keywords
Tamsulosin, Prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose tamsulosin 0.4mg
Arm Type
Active Comparator
Arm Description
Single dose tamsulosin 0.4mg
Arm Title
Double dose tamsulosin 0.4mg
Arm Type
Active Comparator
Arm Description
Double dose tamsulosin 0.4mg
Intervention Type
Drug
Intervention Name(s)
Single dose tamsulosin 0.4mg
Intervention Description
Single dose tamsulosin 0.4mg
Intervention Type
Drug
Intervention Name(s)
Double dose tamsulosin 0.4mg
Intervention Description
Double dose tamsulosin 0.4mg
Primary Outcome Measure Information:
Title
Change in the lower urinary tract symptoms
Description
Assessed by the improvement in the internal prostatic symptoms score (IPSS)
Time Frame
3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age more than 50 years
moderate to severe lower urinary tract symptoms
Exclusion Criteria:
prostatic cancer
urethral stricture
prostate surgery
Neurogenic bladder
Facility Information:
Facility Name
Faculty of Medicine
City
Shibīn Al Kawm
State/Province
Menofia
ZIP/Postal Code
342007
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
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