Ain Shams University
Cairo, Cairo Governorate, 11591, Egypt
Location status: Recruiting
NCT Number: NCT07722884
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Not applicable
Cairo, Cairo Governorate, 11591, Egypt
Location status: Recruiting
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life.
Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS.
The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Time frame: 12 weeks post-procedure
The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH).
Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity.
The score evaluates symptoms into the following categories:
0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms
Time frame: 12 weeks post-procedure
Incidence of adverse events related to Tamsulosin such as dizziness, orthostatic hypotension, headache, fatigue, nasal congestion, retrograde ejaculation, and gastrointestinal disturbances will be recorded.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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