ORIGINAL ARTICLE   Free access

Minerva Urology and Nephrology 2021 December;73(6):836-44

DOI: 10.23736/S2724-6051.20.04099-0

Copyright © 2020 EDIZIONI MINERVA MEDICA

language: English

Outcomes of combination therapy with daily tadalafil 5 mg plus tamsulosin 0.4 mg to treat lower urinary tract symptoms and erectile dysfunction in men with or without metabolic syndrome

Arcangelo SEBASTIANELLI ¹, Simone MORSELLI ¹ ✉, Pietro SPATAFORA ¹, Andrea LIACI ¹, Luca GEMMA ¹, Claudia ZACCARO ¹, Linda VIGNOZZI ², Mario MAGGI ², Kevin T. MCVARY ³, Steven A. KAPLAN ⁴, Christopher CHAPPLE ⁵, Stavros GRAVAS ⁶, Sergio SERNI ¹, Mauro GACCI ¹

¹ Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi Hospital, University of Florence, Florence, Italy; ² Department of Clinical Physiopathology, University of Florence, Florence, Italy; ³ Stritch School of Medicine, Department of Urology, Center for Male Health, Loyola University Medical Center, Maywood, IL, USA; ⁴ Icahn School of Medicine at Mount Sinai, Department of Urology, New York, NY, USA; ⁵ Department of Urology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK; ⁶ Department of Urology, University of Thessaly, Larissa, Greece

BACKGROUND: The aim of this study was to assess the impact of tadalafil 5 mg/die plus tamsulosin 0.4 mg/die combination therapy on lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), according to presence vs. absence of metabolic syndrome (MetS).
METHODS: Seventy-five consecutive men presenting with ED and LUTS were enrolled. Patients were divided into two groups according to MetS presence. All subjects were treated with combination therapy for 12 weeks. Patients were re-evaluated after treatment with uroflowmetry and post-void residual volume (PVR), International Prostate Symptoms Score (IPSS), IPSS Quality of Life (QoL), overactive bladder questionnaire (OAB-q) and International Index Erectile Function-5 (IIEF-5) Score.
RESULTS: After enrollment, 50 patients were included: 31 (62.0%) with MetS and 19 (38.0%) without MetS. At baseline, patients without MetS showed a significantly better IPSS, IIEF and OAB-q, as compared to those with MetS. After 12 weeks of combination therapy LUTS, ED and flowmetry significantly improved in both groups (P<0.001). The improvement after 12 weeks was similar between groups in all parameters (P>0.05), except for ∆OAB-q that was significantly better for patients with MetS (P=0.028). Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS (P<0.05). Despite IIEF-5 was significantly different at baseline, after 12 weeks of combination therapy, erectile function was similar in men with or without METS: 16.3±3.8 vs. 17.7±4.7 (P=0.238). No serious adverse event (AE) was reported, and complications were comparable between groups (P>0.05).
CONCLUSIONS: Patients with MetS have worse LUTS and ED profiles. However, tadalafil plus tamsulosin combination treatment provided them a similar ED profile and a greater relief of overactive bladder (OAB) symptoms at the end of the trial. Combination therapy had the same safety profile in men besides MetS. Further randomized controlled trials are needed.

KEY WORDS: Lower urinary tract symptoms; Erectile dysfunction; Metabolic syndrome; Tadalafil; Tamsulosin