Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe LUTS Due to BPH
Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT05834270
Collaborator
(none)
60
1
2
7
8.5
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Single Dose Versus Double Dose Tamsulosin in Management of Moderate and Severe Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Actual Study Start Date
:
May 1, 2022
Actual Primary Completion Date
:
Dec 1, 2022
Actual Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Single dose tamsulosin 0.4mg Single dose tamsulosin 0.4mg |
Drug: Single dose tamsulosin 0.4mg
Single dose tamsulosin 0.4mg
|
| Active Comparator: Double dose tamsulosin 0.4mg Double dose tamsulosin 0.4mg |
Drug: Double dose tamsulosin 0.4mg
Double dose tamsulosin 0.4mg
|
Outcome Measures
Primary Outcome Measures
- Change in the lower urinary tract symptoms [3 months]
Assessed by the improvement in the internal prostatic symptoms score (IPSS)
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 80 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
age more than 50 years
-
moderate to severe lower urinary tract symptoms
Exclusion Criteria:
-
prostatic cancer
-
urethral stricture
-
prostate surgery
-
Neurogenic bladder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Faculty of Medicine | Shibīn Al Kawm | Menofia | Egypt | 342007 |
Sponsors and Collaborators
- Menoufia University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed M. Hassan,
Dr,
Menoufia University
ClinicalTrials.gov Identifier:
NCT05834270
Other Study ID Numbers:
- SD vs DD Tamsulosin
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed M. Hassan,
Dr,
Menoufia University
Additional relevant MeSH terms: