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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 (DTT-BPH)

15. juli 2026 opdateret af: Yasser Mohamed Nagy Mohamed Khalid, Beni-Suef University

"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"

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

240

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
    • Beni Suef Governorate
      • Banī Suwayf, Beni Suef Governorate, Egypten
        • Beni-Suef University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tamsulosin daily + 5ARI daily
Participants received tamsulosin 0.4 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks.
Medicin: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Medicin: 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.
Eksperimentel: Tamsulosin daily + 5ARI every other day
Participants received tamsulosin 0.4 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Medicin: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Medicin: 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.
Eksperimentel: Tamsulosin every other day + 5ARI every other day
Participants received tamsulosin 0.4 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Medicin: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Medicin: 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.
Eksperimentel: Tadalafil daily + 5ARI daily
Participants received tadalafil 5 mg once daily in combination with a 5-alpha reductase inhibitor administered once daily for 12 weeks.
Medicin: 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.
Medicin: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Eksperimentel: Tadalafil daily + 5ARI every other day
Participants received tadalafil 5 mg once daily combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Medicin: 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.
Medicin: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Eksperimentel: Tadalafil every other day + 5ARI every other day
Participants received tadalafil 5 mg every other day combined with a 5-alpha reductase inhibitor administered every other day for 12 weeks.
Medicin: 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.
Medicin: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Lower Urinary Tract Symptoms (IPSS)
Tidsramme: Baseline and Week 12
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Erectile Function
Tidsramme: Baseline and Week 12
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.
Baseline and Week 12
Change in Ejaculatory Function
Tidsramme: Baseline and Week 12
Change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score from baseline to Week 12.
Baseline and Week 12
Change in Maximum Urinary Flow Rate (Qmax)
Tidsramme: Baseline and Week 12
Change in maximum urinary flow rate measured by uroflowmetry from baseline to Week 12.
Baseline and Week 12
Change in Prostate Volume
Tidsramme: Baseline and Week 12
Change in prostate volume measured by transrectal ultrasonography (TRUS) from baseline to Week 12.
Baseline and Week 12
Change in Prostate-Specific Antigen (PSA)
Tidsramme: Baseline and Week 12
Change in serum prostate-specific antigen (PSA) level from baseline to Week 12.
Baseline and Week 12
Change in Post-Void Residual Volume (PVR)
Tidsramme: Baseline and Week 12
Change in post-void residual urine volume measured by bladder ultrasound from baseline to Week 12.
Baseline and Week 12
Incidence of Treatment-Related Adverse Events
Tidsramme: Throughout the 12-week treatment period
Frequency and type of treatment-emergent adverse events, including dizziness, orthostatic hypotension, headache, flushing, dyspepsia, gynecomastia, decreased libido, erectile dysfunction, and ejaculatory dysfunction.
Throughout the 12-week treatment period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beni-Suef University

Efterforskere

  • Ledende efterforsker: Omar S Taha, MBBCh, Department of Urology, Faculty of Medicine, Beni-Suef University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Primær færdiggørelse (Faktiske)

1. januar 2026

Studieafslutning (Faktiske)

1. januar 2026

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FMBSUREC/07092025/Taha

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