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. 2019 Jul 29;8(8):1126.
doi: 10.3390/jcm8081126.

Tadalafil 5 mg Alone or in Combination with Tamsulosin 0.4 mg for the Management of Men with Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Prospective Observational Trial

Arcangelo Sebastianelli  1 , Pietro Spatafora  2 , Jacopo Frizzi  2 , Omar Saleh  2 , Maurizio Sessa  3 , Cosimo De Nunzio  4 , Andrea Tubaro  4 , Linda Vignozzi  5 , Mario Maggi  5 , Sergio Serni  2 , Kevin T McVary  6 , Steven A Kaplan  7 , Stavros Gravas  8 , Christopher Chapple  9 , Mauro Gacci  2
Affiliations

Tadalafil 5 mg Alone or in Combination with Tamsulosin 0.4 mg for the Management of Men with Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Prospective Observational Trial

Arcangelo Sebastianelli et al. J Clin Med. .

Abstract

Tadalafil 5 mg represents the standard for men with Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE). We carried out an observational trial aiming to assess the efficacy and safety of Tadalafil compared with Tadalafil plus Tamsulosin. Seventy-five patients complaining of ED and LUTS were treated for 12-weeks with Tadalafil plus placebo (TAD+PLA-group) or with combination therapy tadalafil plus tamsulosin (TAD+TAM-group). Efficacy variables were: International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax) and safety assessments. Data were evaluated using paired samples T-test (baseline vs. 12-weeks) and analysis of variance (Δgroup-TAD+PLA vs. Δgroup-TAD+TAM). At baseline, both groups presented similar characteristics and symptoms scores (all: p > 0.05). From baseline to 12-weeks, all the subjects showed a significant improvement of IIEF, total-IPSS, storage-IPSS, Qmax (all: p < 0.001). Conversely, a significant improvement of voiding-IPSS was observed in TAD+TAM-group (-3.5 points, p < 0.001). Indeed, TAD+PLA-group showed a not significant improvement of voiding-IPSS (-2.0 points, p = 0.074). When we compared between-groups differences at 12-weeks, IIEF (p = 0.255), total-IPSS (p = 0.084) and storage-IPSS (p = 0.08) did not show any statistically significant differences, whereas, voiding-IPSS and Qmax were significantly better in TAD+TAM-group (p = 0.006 and p = 0.027, respectively). No severe treatment adverse events (TAEs) were reported in both groups. Tadalafil achieved the same improvements of IIEF, total-IPSS, storage-IPSS when compared to combination therapy. Instead, Qmax and voiding-IPSS were better managed with combination therapy, without change of TAEs.

Keywords: benign prostatic hyperplasia; erectile dysfunction; lower urinary tract symptoms; medical therapy; tadalafil; tamsulosin.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Disposition of subjects according to Subject Consolidated Standards of Reporting Trials (CONSORT) diagram.
Figure 2
Figure 2
Change from baseline to 12 weeks for tadalafil and tadalafil plus tamsulosin (combination) groups. Graphical representation of the significant differences between the two groups. IPSS = International Prostate Symptom Score.
See this image and copyright information in PMC

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