A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction

Eusebio Rubio-Aurioles, Hartmut Porst, Edward Kim, Francesco Montorsi, Geoff Hackett, Antonio Martin Morales, Bronwyn Stuckey, Hartwig Buttner, Teena M. West, Ngan N. Huynh, Enrique Lenero, Patrick Burns, Vladimir Kopernicky

Research output: Contribution to journalArticle

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Abstract

Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

Original languageEnglish (US)
Pages (from-to)1418-1429
Number of pages12
JournalJournal of Sexual Medicine
Volume9
Issue number5
DOIs
StatePublished - Jan 1 2012

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Erectile Dysfunction
Self Concept
Phosphodiesterase 5 Inhibitors
Sildenafil Citrate
Tadalafil
Psychology
Cross-Over Studies
Outcome Assessment (Health Care)
Confidence Intervals
Least-Squares Analysis

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Urology

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A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction. / Rubio-Aurioles, Eusebio; Porst, Hartmut; Kim, Edward; Montorsi, Francesco; Hackett, Geoff; Morales, Antonio Martin; Stuckey, Bronwyn; Buttner, Hartwig; West, Teena M.; Huynh, Ngan N.; Lenero, Enrique; Burns, Patrick; Kopernicky, Vladimir.

In: Journal of Sexual Medicine, Vol. 9, No. 5, 01.01.2012, p. 1418-1429.

Research output: Contribution to journalArticle

Rubio-Aurioles, Eusebio ; Porst, Hartmut ; Kim, Edward ; Montorsi, Francesco ; Hackett, Geoff ; Morales, Antonio Martin ; Stuckey, Bronwyn ; Buttner, Hartwig ; West, Teena M. ; Huynh, Ngan N. ; Lenero, Enrique ; Burns, Patrick ; Kopernicky, Vladimir. / A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction. In: Journal of Sexual Medicine. 2012 ; Vol. 9, No. 5. pp. 1418-1429.
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abstract = "Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69{\%} prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.",
author = "Eusebio Rubio-Aurioles and Hartmut Porst and Edward Kim and Francesco Montorsi and Geoff Hackett and Morales, {Antonio Martin} and Bronwyn Stuckey and Hartwig Buttner and West, {Teena M.} and Huynh, {Ngan N.} and Enrique Lenero and Patrick Burns and Vladimir Kopernicky",
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T1 - A Randomized Open-Label Trial with a Crossover Comparison of Sexual Self-Confidence and Other Treatment Outcomes Following Tadalafil Once a Day Vs. Tadalafil or Sildenafil On-Demand in Men with Erectile Dysfunction

AU - Rubio-Aurioles, Eusebio

AU - Porst, Hartmut

AU - Kim, Edward

AU - Montorsi, Francesco

AU - Hackett, Geoff

AU - Morales, Antonio Martin

AU - Stuckey, Bronwyn

AU - Buttner, Hartwig

AU - West, Teena M.

AU - Huynh, Ngan N.

AU - Lenero, Enrique

AU - Burns, Patrick

AU - Kopernicky, Vladimir

PY - 2012/1/1

Y1 - 2012/1/1

N2 - Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

AB - Aim. To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5mg once a day (OaD) vs. tadalafil 20mg or sildenafil 100mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED). Methods. A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN. Data were analyzed with a mixed effects model for crossover design. Main Outcome Measures. The primary outcome measure was the Sexual Self-Confidence domain of the Psychological and Interpersonal Relationship Scales (PAIRS) between tadalafil OaD and sildenafil PRN. Secondary Outcomes Included. Time Concerns and Spontaneity domains of PAIRS, and the Self-Esteem and Relationship (SEAR) scale. Results. Men naive to tadalafil OaD were enrolled (N=378), with 61-69% prior PDE5 inhibitor use. There were improvements in all PAIRS domains from baseline when comparing tadalafil OaD and PRN with sildenafil PRN (P<0.001). The Sexual Self-Confidence domain improved from baseline and was 0.50±0.78 following tadalafil OaD, 0.5±0.72 for tadalafil PRN, and 0.39±0.67 for sildenafil PRN. The difference in least-squares mean was 0.12±0.04 (confidence interval [CI]=0.04, 0.19; P=0.001) between tadalafil OaD and sildenafil PRN and 0.01±0.04 (CI=-0.06, 0.08; P=0.872) between tadalafil OaD and tadalafil PRN. The Time Concerns domain score was lower with tadalafil OaD than tadalafil PRN (P<0.001). There were no differences in SEAR scores between treatments. Conclusions. Tadalafil OaD and tadalafil PRN compared with sildenafil PRN demonstrated greater improvements in Sexual Self-Confidence, Time Concerns, and Spontaneity. There was no significant difference in Sexual Self-Confidence between tadalafil OaD and tadalafil PRN. Changes in SEAR, the erectile function domain of the International Index of Erectile Function, and the Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to end point were similar.

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