The purposeof this study is to investigate and compare the effects of 5-mg once-daily tadalafil versus 5-mg alternate-day tadalafil in men with moderate-to-severe erectile dysfunction (ED) and lower urinary tract symptoms (LUTS). Between January 2012 and June 2013, 144 men presenting with an International Index of Erectile Function-5 (IIEF-5) score of <18 and an International Prostate Symptom Score (IPSS) of >8 were enrolled to the study. Patients were allocated the simple alternate randomization into Group I (5-mg once-daily tadalafil) and Group II (5-mg alternate-day tadalafil). Changes in IIEF scores, Sexual Encounter Profile Question 3 (SEP Q3) percentage, IPSS, uroflowmetry and post void residual at the first visit (V1), week 4 (V2) and week 12 (V3) were compared. No significant difference was found between the baseline patient characteristics of Group I and Group II. Treatment with 5-mg daily tadalafil demonstrated improvement in IIEF, SEP Q3 percentage and IPSS score between V1 and V2, and that between V1 and V3. Patients receiving 5-mg alternate-day tadalafil also showed a significant improvement in IIEF, SEP Q3 percentage, and IPSS score between V1 and V2, and that between V2 and V3. However, no significant improvements were found in any other parameters. There were no significant differences between Group I and Group II apart from IIEF scores in V2 (19.4 versus 17.9, respectively). The SEP Q3 percentage was also higher at the V2 visit for Group I and Group II (35.6 versus 30.9%). Even with no placebo control and short of LUTS medication control, the use of 5-mg once-daily or alternate-day treatment with tadalafil was well tolerated in patients and effectively improved the IIEF score, IPSS score and SEP Q3 percentage. Management of patients with 5-mg alternate-day tadalafil could be adequate for regular use in patients with ED and LUTS.
Subscribe to Journal
Get full journal access for 1 year
only $47.57 per issue
All prices are NET prices.
VAT will be added later in the checkout.
Rent or Buy article
Get time limited or full article access on ReadCube.
All prices are NET prices.
Wespes E, Amar E, Hatzichristou D, Hatzimouratidis K, Montorsi F, Pryor J et al. EAU guidelines on erectile dysfunction: an update. Eur Urol 2006; 49: 806–815.
Hackett GI . Patient preferences in treatment of erectile dysfunction: the continuing importance of patient education. Clin Corner Stone 2005; 7: 57–65.
Hatzimouratidis K, Amar E, Eardley I, Giuliano F, Hatzichristou D, Montorsi F et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol 2010; 57: 804–814.
Eardley I, Donatucci C, Corbin J, El-Meliegy A, Hatzimouratidis K, McVary K et al. Pharmacotherapy for erectile dysfunction. J Sex Med 2010; 7: 524–540.
McMahon CG . Treatment of erectile dysfunction with chronic dosing of tadalafil. Eur Urol 2006; 50: 215–217.
Porst H, Hell-Momeni K, Büttner H . Chronic PDE-5 inhibition in patients with erectile dysfunction - a treatment approach using tadalafil once-daily. Expert Opin Pharmacother 2012; 13: 1481–1494.
Washington SL 3rd, Shindel AW . A once-daily dose of tadalafil for erectile dysfunction: compliance and efficacy. Drug Des Devel Ther 2010; 4: 159–171.
Porst H . Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Urology 2003; 62: 121–125.
Forgue ST . Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol 2006; 61: 280–288.
Gacci M, Eardley I, Giuliano F, Hatzichristou D, Kaplan SA, Maggi M et al. Critical analysis of the relationship between sexual dysfunctions and lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2011; 60: 809–825.
McVary KT, Roehrborn CG, Kaminetsky JC, Auerbach SM, Wachs B, Young JM et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2007; 177: 1401–1407.
Rajfer J, Aliotta PJ, Steidle CP, Fitch WP 3rd, Zhao Y, Yu A . Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res 2007; 19: 95–103.
McMahon C . Comparison of efficacy, safety, and tolerability of on-demand tadalafil and daily dosed tadalafil for the treatment of erectile dysfunction. J Sex Med 2005; 2: 415–425.
Sommer F, Klotz T, Engelmann U . Improved spotaneous erectile function in men with mild-to-moderate arteriogenic erectile dysfunction treated with a nightly dose of sildenafil for one year: a randomized trial. Asian J Androl 2007; 9: 134–141.
Brody S, Costa RM . Satisfaction (sexual, life, relationship, and mental health) is associated directly with penile-vaginal intercourse but inversely with other sexual behavior frequencies. J Sex Med 2009; 6: 1947–1954.
Kang DH, Lee JY, Park SY, Moon HS, Jeong TY, Lee SW et al. Efficacy and safety of tadalafil 5 mg administered once daily in korean men with erectile dysfunction: a prospective, multicenter study. Korean J Urol 2010; 51: 647–652.
Eardley I, Cartledge J . Tadalafil (Cialis) for men with erectile dysfunction. Int J Clin Pract 2002; 56: 300–304.
Sung HH, Lee SW . Chronic low dosing of phosphodiesterase type 5 inhibitor for erectile dysfunction. Korean J Urol 2012; 53: 377–385.
Wrishko R, Sorsaburu S, Wong D, Strawbridge A, McGill J . Safety efficacy, and pharmacokinetic overview of low-dose daily administration of tadalafil. J Sex Med 2009; 6: 2039–2048.
McMahon C . Efficacy and safety of daily tadalafil in men with erectile dysfunction previously unresponsive to on-demand tadalafil. J Sex Med 2004; 1: 292–300.
Shabsigh R, Costabile R, Perelman MA, Burns P, Zeigler H, Wong DG et al. Reliability of efficacy in men with erectile dysfunction treated with tadalafil once daily after initial success. Int J Impot Res 2010; 22: 1–8.
Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L . Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a dose finding study. J Urol 2008; 180: 1228–1234.
Porst H, Kim ED, Casabe AR, Mirone V, Secrest RJ, Xu L et al. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: results of an international randomized, double-blind, placebo-controlled trial. Eur Urol 2011; 60: 1105–1113.
Egerdie RB, Auerbach S, Roehrborn CG, Costa P, Garza MS, Esler AL et al. Tadalafil 2.5 or 5 mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: results of a randomized, placebo-controlled, double-blind study. J Sex Med 2012; 9: 271–281.
Gacci M, Corona G, Salvi M, Vignozzi L, McVary KT, Kaplan SA et al. A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with α-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2012; 61: 994–1003.
Mirone V, Costa P, Damber JE, Holmes S, Moncada I, Van Ahlen H et al. An evaluation of an alternative dosing regimen with tadalafil, 3 times/week, for men with erectile dysfunction: SURE study in 14 European countries. Eur Urol 2005; 47: 846–854.
Gacci M, Salvi M, Sebastianelli A, Vignozzi L, Corona G, McVary KT et al. The use of a single daily dose of tadalafil to treat signs and symptoms of benign prostatic hyperplasia and erectile dysfunction. Res Rep Urol 2013; 5: 99–111.
Liu L, Zheng S, Han P, Wei Q . Phosphodiesterase-5 inhibitors for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a systematic review and meta-analysis. Urology 2011; 77: 123–129.
Konstantinopoulos A, Giannitsas K, Athanasopoulos A, Spathas D, Perimenis P . The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction. Expert Opin Pharmacother 2009; 10: 155–160.
Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, Lee SW et al. Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo- controlled trial. Eur Urol 2011; 60: 380–387.
Chung JH, Kang DH, Oh CY, Chung JM, Lee KS, Lee SW et al. Safety and efficacy of once daily administration of 50 mg mirodenafil in patients with erectile dysfunction: a multicenter, double-blind, placebo controlled trial. J Urol 2013; 189: 1006–1013.
Reginster JY, Rabenda V, Neuprez A . Adherence, patient preference and dosing frequency: understanding the relationship. Bone 2006; 38: S2–86.
Burkhart PV, Sabate E . Adherence to long-term therapies: evidence for action. J Nurs Scholar 2003; 35: 207.
Stroberg P, Hedelin H, Bergström A . Is sex only for the healthy and wealthy? J Sex Med 2007; 4: 176–182.
Teloken P, Mesquita G, Montorsi F, Mulhall J . Post-radical prostatectomy pharmacological penile rehabilitation: practice patterns among the international society for sexual medicine practitioners. J Sex Med 2009; 6: 2032–2038.
The authors declare no conflict of interest.
About this article
Cite this article
Choi, H., Kim, J., Shim, J. et al. Comparison of the efficacy and safety of 5-mg once-daily versus 5-mg alternate-day tadalafil in men with erectile dysfunction and lower urinary tract symptoms. Int J Impot Res 27, 33–37 (2015) doi:10.1038/ijir.2014.19
Effect of tadalafil 5 mg on post-micturition dribble in men with lower urinary tract symptoms: a multicentre, double-blind, randomized, placebo-controlled trial
BJU International (2019)
Pharmaceutical Development and Technology (2019)
Two Birds with One Stone: Regular Use of PDE5 Inhibitors for Treating Male Patients with Erectile Dysfunction and Cardiovascular Diseases
Cardiovascular Drugs and Therapy (2019)
Archives of Physical Medicine and Rehabilitation (2016)