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A Prospective Study Comparing: Tadalafil 5mg Vs Tadalafil 10mg Vs the Combination of Tadalafil 5mg And Tamsulosin 0.4 mg In Cases of Moderate And Sever Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

A Prospective Study Comparing: Tadalafil 5mg Vs Tadalafil 10mg Vs the Combination of Tadalafil 5mg And Tamsulosin 0.4 mg In Cases of Moderate And Sever Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202506840472754
Enrollment
171
Registered
2025-06-23
Start date
2025-06-15
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and Genital Diseases

Interventions

Tadalafil capsule
Combination of tadalafil and tamsulosin

Sponsors

Tanta University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients above 50 years old and less than 80 years old who presented by LUTs due to BPH: - IPPS more than 7 - PVR less than 150 cc - Ability to provide informed consent and comply with study requirements

Exclusion criteria

Exclusion criteria: - Suspicious Cancer prostate. - Complicated BPH (refractory urine retention, recurrent UTI, recurrent Urinary bladder stone, gross hematuria secondary to BPH). - Insufficient renal function (s. creatinine >2 mg/dl) - Spinal cord injury - Active urinary tract infection - Cardiovascular diseases (unstable angina, recent myocardial infarction, poorly controlled blood pressure) - Hypotension - Recent treatment with nitrate - Previous prostate surgery (e.g. TURP, prostatectomy) - Urinary bladder cancer - Known hypersensitivity to study medication - Patient refused to be rolled in the study.

Design outcomes

Primary

MeasureTime frame
Change in International Prostate Symptom Score (IPSS) from baseline to 12 weeks following start of treatment

Secondary

MeasureTime frame
- Quality of life assessment (BPH-QOL) - Improvement in peak urinary flow rate (Q-max) - Assessment of side effects and adverse events - Effect on erectile function

Countries

Egypt

Contacts

Public ContactAyman Hassan

Professor of Urology at Tanta University Hospital

aym_hassan@yahoo.com00201149009977

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026