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; Pietro Spatafora; Jacopo Frizzi; Omar Saleh; Maurizio Sessa; Cosimo De Nunzio; Andrea Tubaro; Linda Vignozzi; Mario Maggi; Sergio Serni; Kevin T McVary; Steven A Kaplan; Stavros Gravas; Christopher Chapple; Mauro Gacci

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, Pietro Spatafora, Jacopo Frizzi, Omar Saleh, Maurizio Sessa, Cosimo De Nunzio, Andrea Tubaro, Linda Vignozzi, Mario Maggi, Sergio Serni, Kevin T McVary, Steven A Kaplan, Stavros Gravas, Christopher Chapple, Mauro Gacci

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 (∆group-TAD+PLA vs. ∆group-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.

Original language	English
Journal	Journal of Clinical Medicine
Volume	8
Issue number	8
ISSN	2077-0383
DOIs	https://doi.org/10.3390/jcm8081126
Publication status	Published - Aug 2019

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Sebastianelli, A., Spatafora, P., Frizzi, J., Saleh, O., Sessa, M., De Nunzio, C., Tubaro, A., Vignozzi, L., Maggi, M., Serni, S., McVary, K. T., Kaplan, S. A., Gravas, S., Chapple, C., & Gacci, M. (2019). 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. Journal of Clinical Medicine, 8(8). https://doi.org/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. / Sebastianelli, Arcangelo; Spatafora, Pietro; Frizzi, Jacopo et al.
In: Journal of Clinical Medicine, Vol. 8, No. 8, 08.2019.

Research output: Contribution to journal › Journal article › Research › peer-review

Sebastianelli, A, Spatafora, P, Frizzi, J, Saleh, O, Sessa, M, De Nunzio, C, Tubaro, A, Vignozzi, L, Maggi, M, Serni, S, McVary, KT, Kaplan, SA, Gravas, S, Chapple, C & Gacci, M 2019, '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', Journal of Clinical Medicine, vol. 8, no. 8. https://doi.org/10.3390/jcm8081126

@article{87b49d05a6db41b0a4e2c9c27187064f,

title = "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",

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 (∆group-TAD+PLA vs. ∆group-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.",

author = "Arcangelo Sebastianelli and Pietro Spatafora and Jacopo Frizzi and Omar Saleh and Maurizio Sessa and {De Nunzio}, Cosimo and Andrea Tubaro and Linda Vignozzi and Mario Maggi and Sergio Serni and McVary, {Kevin T} and Kaplan, {Steven A} and Stavros Gravas and Christopher Chapple and Mauro Gacci",

year = "2019",

month = aug,

doi = "10.3390/jcm8081126",

language = "English",

volume = "8",

journal = "Journal of Clinical Medicine",

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TY - JOUR

T1 - 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

T2 - Results of a Prospective Observational Trial

AU - Sebastianelli, Arcangelo

AU - Spatafora, Pietro

AU - Frizzi, Jacopo

AU - Saleh, Omar

AU - Sessa, Maurizio

AU - De Nunzio, Cosimo

AU - Tubaro, Andrea

AU - Vignozzi, Linda

AU - Maggi, Mario

AU - Serni, Sergio

AU - McVary, Kevin T

AU - Kaplan, Steven A

AU - Gravas, Stavros

AU - Chapple, Christopher

AU - Gacci, Mauro

PY - 2019/8

Y1 - 2019/8

N2 - 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 (∆group-TAD+PLA vs. ∆group-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.

AB - 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 (∆group-TAD+PLA vs. ∆group-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.

U2 - 10.3390/jcm8081126

DO - 10.3390/jcm8081126

M3 - Journal article

C2 - 31362410

SN - 2077-0383

VL - 8

JO - Journal of Clinical Medicine

JF - Journal of Clinical Medicine

IS - 8

ER -

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

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