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Minerva Urologica e Nefrologica 2020 Nov 17

DOI: 10.23736/S0393-2249.20.04099-0


language: English

Outcomes of combination therapy with daily Tadalafil 5mg plus Tamsulosin 0.4mg 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, University of Florence, Careggi Hospital, Florence, Italy; 2 Department of Clinical Physiopathology, University of Florence, Florence, Italy; 3 Center for Male Health, Department of Urology, Stritch School of Medicine, Loyola University Medical Center, Maywood, IL, USA; 4 Department of Urology, Icahn School of Medicine at Mount Sinai, New York City, NY, USA; 5 Department of Urology, Sheffield Teaching Hospitals NHS Trust, Sheffield, UK; 6 Department of Urology, University of Thessaly, Larissa, Greece


BACKGROUND: To assess the impact of Tadalafil 5mg/die plus Tamsulosin 0.4mg/die combination therapy on LUTS and ED, according to presence vs. absence of Mets.
METHODS: 75 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 PVR, IPSS, IPSS QoL, OAB-q and IIEF-5.
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 ΔOAB-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 7.7±4.7(p=0.238). No serious 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 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: LUTS; Erectile dysfunction; Metabolic syndrome; Tadalafil; Tamsulosin

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