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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 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

240

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Droga: 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.
Sperimentale: 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.
Droga: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Droga: 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.
Sperimentale: 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.
Droga: Tamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Droga: 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.
Sperimentale: 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.
Droga: 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.
Droga: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Sperimentale: 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.
Droga: 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.
Droga: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Sperimentale: 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.
Droga: 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.
Droga: Tadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Lower Urinary Tract Symptoms (IPSS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Erectile Function
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beni-Suef University

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Completamento primario (Effettivo)

1 gennaio 2026

Completamento dello studio (Effettivo)

1 gennaio 2026

Date di iscrizione allo studio

Primo inviato

15 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FMBSUREC/07092025/Taha

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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