A Phase 4 interventional study of Tamsulosin and Tadalafil in Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms and Erectile Dysfunction, sponsored by Beni-Suef University. Completed at 1 site in Egypt. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Beni-Suef University · Phase 4, Interventional, and Treatment
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Benign prostatic hyperplasia (BPH) is one of the most common causes of lower urinary tract symptoms (LUTS) in older men and is frequently associated with impaired sexual function. Alpha-blockers and 5-alpha reductase inhibitors (5ARIs) are widely used for medical management; however, both treatment strategies may adversely affect sexual function. Phosphodiesterase type-5 inhibitors, particularly tadalafil, have emerged as an alternative therapeutic option because they improve LUTS while preserving erectile function.
This randomized, single-blind, controlled clinical trial was conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University, Egypt. The study enrolled 240 eligible men aged 50 years or older with moderate-to-severe LUTS secondary to BPH and prostate volume greater than 40 mL. Participants were randomly allocated into six equal treatment groups comparing different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors.
The primary objective was to compare improvements in lower urinary tract symptoms using the International Prostate Symptom Score (IPSS). Secondary objectives included evaluation of erectile function using the International Index of Erectile Function-Erectile Function domain (IIEF-EF), ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), maximum urinary flow rate (Qmax), prostate volume, prostate-specific antigen (PSA), post-void residual urine volume (PVR), and treatment-related adverse events.
Participants received treatment for 12 weeks and were assessed at baseline and at the end of the study. Safety was evaluated by monitoring adverse events throughout the study. The findings are expected to identify the most effective and well-tolerated combination regimen for improving both urinary and sexual outcomes in men with benign prostatic hyperplasia.
783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 240 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.
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Exclusion Criteria:
Participants received tamsulosin 0.4 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks.
Drug: Tamsulosin · Drug: 5-Alpha Reductase Inhibitor
Participants received tamsulosin 0.4 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Drug: Tamsulosin · Drug: 5-Alpha Reductase Inhibitor
Participants received tamsulosin 0.4 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Drug: Tamsulosin · Drug: 5-Alpha Reductase Inhibitor
Participants received tadalafil 5 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks.
Drug: Tadalafil · Drug: 5-Alpha Reductase Inhibitor
Participants received tadalafil 5 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Drug: Tadalafil · Drug: 5-Alpha Reductase Inhibitor
Participants received tadalafil 5 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Drug: Tadalafil · Drug: 5-Alpha Reductase Inhibitor
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
A 5-alpha reductase inhibitor (finasteride 5 mg or dutasteride 0.5 mg according to routine clinical practice) administered either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Change in Lower Urinary Tract Symptoms (IPSS)
Change in the International Prostate Symptom Score (IPSS) from baseline to Week 12. Higher scores indicate more severe symptoms; a reduction in score reflects clinical improvement.
Time frame: Baseline and Week 12
Change in Erectile Function
Change in the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to Week 12. Higher scores indicate better erectile function.
Time frame: Baseline and Week 12
Change in Ejaculatory Function
Change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score from baseline to Week 12.
Time frame: Baseline and Week 12
Change in Maximum Urinary Flow Rate (Qmax)
Change in maximum urinary flow rate measured by uroflowmetry from baseline to Week 12.
Time frame: Baseline and Week 12
Change in Prostate Volume
Change in prostate volume measured by transrectal ultrasonography (TRUS) from baseline to Week 12.
Time frame: Baseline and Week 12
Change in Prostate-Specific Antigen (PSA)
Change in serum prostate-specific antigen (PSA) level from baseline to Week 12.
Time frame: Baseline and Week 12
Change in Post-Void Residual Volume (PVR)
Change in post-void residual urine volume measured by bladder ultrasound from baseline to Week 12.
Time frame: Baseline and Week 12
Incidence of Treatment-Related Adverse Events
Frequency and type of treatment-emergent adverse events, including dizziness, orthostatic hypotension, headache, flushing, dyspepsia, gynecomastia, decreased libido, erectile dysfunction, and ejaculatory dysfunction.
Time frame: Throughout the 12-week treatment period
Plan to share: No
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Beni-Suef University