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Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia
Sponsor: Beni-Suef University
Summary
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.
Official title: "Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia: A Comparative Clinical Trial Study"
Key Details
Gender
MALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
Not specified
Completion Date
2026-01-01
Last Updated
2026-07-20
Healthy Volunteers
No
Interventions
Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
5-Alpha Reductase Inhibitor
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.
Locations (1)
Beni-Suef University Hospital
Banī Suwayf, Beni Suef Governorate, Egypt