drugset / Trial / NCT02450188
Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the present study is to evaluate the efficacy of a combined approach with Vardenafil orodispersible and Cognitive Behavioural Sex Therapy in the treatment of Erectile Dysfunction, compared to medical only treatment, in terms of quality and duration of erection and couple's sexual satisfaction.
Timeline
- Start
- 2012-03
- Primary completion
- 2014-01
- Completion
- 2014-01
Publications
- Background Dean J, Rubio-Aurioles E, McCabe M, Eardley I, Speakman M, Buvat J, de Tejada IS, Fisher W. Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008 Jan;62(1):127-33. doi: 10.1111/j.1742-1241.2007.01636.x. Epub 2007 Nov 19.
- Background Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M. Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20. doi: 10.1038/sj.ijir.3901006.
- Background Banner LL, Anderson RU. Integrated sildenafil and cognitive-behavior sex therapy for psychogenic erectile dysfunction: a pilot study. J Sex Med. 2007 Jul;4(4 Pt 2):1117-25. doi: 10.1111/j.1743-6109.2007.00535.x.
- Background Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson KE, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, Eardley I, Fugl-Meyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, Wasserman M. Summary of the recommendations on sexual dysfunctions in men. J Sex Med. 2010 Nov;7(11):3572-88. doi: 10.1111/j.1743-6109.2010.02062.x.
- Results Boddi V, Castellini G, Casale H, Rastrelli G, Boni L, Corona G, Maggi M. An integrated approach with vardenafil orodispersible tablet and cognitive behavioral sex therapy for treatment of erectile dysfunction: a randomized controlled pilot study. Andrology. 2015 Sep;3(5):909-18. doi: 10.1111/andr.12079.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Vardenafil | Small molecule | 10 mg | — |