Effect of Different Dosing Regimens of Tadalafil or Tamsulosin Combined With 5α-Reductase Inhibitors on Urinary and Sexual Outcomes in Benign Prostatic Hyperplasia

NCT07715448 | Completed Phase 4

• 1 other identifier: FMBSUREC/07092025/Taha
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction

Keywords

Benign Prostatic Hyperplasia; BPH; Lower Urinary Tract Symptoms; LUTS; Tadalafil; Tamsulosin; 5-Alpha Reductase Inhibitors; 5ARI; Finasteride; Dutasteride; Phosphodiesterase-5 Inhibitors; PDE5 Inhibitors; Erectile Function; Ejaculatory Dysfunction; IPSS; Randomized Controlled Trial; Urology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (7)

• Change in Erectile Function

  Baseline and Week 12

• Change in Ejaculatory Function

  Baseline and Week 12

• Change in Maximum Urinary Flow Rate (Qmax)

  Baseline and Week 12

• Change in Prostate Volume

  Baseline and Week 12

• Change in Prostate-Specific Antigen (PSA)

  Baseline and Week 12

Study Arms (6)

Tamsulosin daily + 5ARI daily

EXPERIMENTAL

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

Tamsulosin daily + 5ARI every other day

EXPERIMENTAL

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

Tamsulosin every other day + 5ARI every other day

EXPERIMENTAL

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

Tadalafil daily + 5ARI daily

EXPERIMENTAL

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

Tadalafil daily + 5ARI every other day

EXPERIMENTAL

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

Tadalafil every other day + 5ARI every other day

EXPERIMENTAL

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

Interventions

Tamsulosin DRUG

Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.

Tamsulosin daily + 5ARI daily; Tamsulosin daily + 5ARI every other day; Tamsulosin every other day + 5ARI every other day

Tadalafil DRUG

Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.

Tadalafil daily + 5ARI daily; Tadalafil daily + 5ARI every other day; Tadalafil every other day + 5ARI every other day

5-Alpha Reductase Inhibitor DRUG

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.

Tadalafil daily + 5ARI daily; Tadalafil daily + 5ARI every other day; Tadalafil every other day + 5ARI every other day; Tamsulosin daily + 5ARI daily; Tamsulosin daily + 5ARI every other day; Tamsulosin every other day + 5ARI every other day

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male participants aged 50 years or older.
• Newly diagnosed with benign prostatic hyperplasia (BPH).
• Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) \> 7.
• Prostate volume \>40 mL confirmed by transrectal ultrasonography (TRUS).
• Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score \>10.
• Prostate-specific antigen (PSA) \<4 ng/mL and no suspicious findings on digital rectal examination (DRE).
• Able and willing to provide written informed consent.

You may not qualify if:

• History of prostate cancer.
• Previous prostate surgery.
• Abnormal digital rectal examination suggestive of malignancy.
• Severe erectile dysfunction (IIEF-EF score ≤10).
• Uncontrolled diabetes mellitus.
• Uncontrolled cardiovascular disease.
• Neurological disorders affecting bladder function.
• Renal impairment.
• Hepatic impairment.
• Active urinary tract infection.
• Bladder stones or other significant urological pathology.
• Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors.
• Patients actively seeking fertility treatment.
• Current use of medications known to significantly affect sexual function.
• Concurrent use of nitrates or contraindicated antihypertensive medications.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suef Governorate, Egypt

Location

Related Publications (3)

• Gacci M, Ficarra V, Sebastianelli A, Corona G, Serni S, Shariat SF, Maggi M, Zattoni F, Carini M, Novara G. Impact of medical treatments for male lower urinary tract symptoms due to benign prostatic hyperplasia on ejaculatory function: a systematic review and meta-analysis. J Sex Med. 2014 Jun;11(6):1554-66. doi: 10.1111/jsm.12525. Epub 2014 Apr 7.

  PMID: 24708055 BACKGROUND

• Lepor H. Alpha blockers for the treatment of benign prostatic hyperplasia. Rev Urol. 2007 Fall;9(4):181-90.

  PMID: 18231614 BACKGROUND

• Giuliano F, Uckert S, Maggi M, Birder L, Kissel J, Viktrup L. The mechanism of action of phosphodiesterase type 5 inhibitors in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia. Eur Urol. 2013 Mar;63(3):506-16. doi: 10.1016/j.eururo.2012.09.006. Epub 2012 Sep 11.

  PMID: 23018163 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction; Ejaculatory Dysfunction

Interventions

Tamsulosin; Tadalafil; 5-alpha Reductase Inhibitors

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• Omar S Taha, MBBCh

  Department of Urology, Faculty of Medicine, Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to treatment allocation to minimize assessment bias. Participants received one of the six randomized treatment regimens throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.B.B.Ch., Faculty of Medicine, Beni-Suef University

Model Details: Participants were randomly assigned in a 1:1:1:1:1:1 ratio into six parallel treatment groups to compare different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors. Each participant received only one assigned treatment regimen throughout the 12-week study period.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)