Erectile Dysfunction Clinical Trial
— STEDOVOfficial title:
An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)
Verified date | October 2018 |
Source | University of Florence |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - This study involved 30 male patients with ED, and their partners, both aged > 18 years and in a stable heterosexual relationship (> 6 months), seeking medical care for sexual dysfunction at Andrology Unit of University of Florence, Florence, Italy Exclusion Criteria: - Couples were excluded from participation if man had unstable medical conditions - Prior pelvic surgery or trauma - Spinal cord injury - Prostate surgery or radiation - Diabetes mellitus - Neurogenic trauma - Retinitis pigmentosa - Peyronie's disease - Multiple sclerosis - Substance abuse disorder - Significant mental health problems requiring psychotropic drugs, or were receiving medication for heart disease/angina (especially nitrates) or vascular disease. - Testosterone levels has been considered normal for plasma levels = 12 nmol/L and/or calculated free testosterone= 225 pmol/L. - When a diagnosis of hypogonadism was made, an adequate testosterone replacement therapy was assessed. - Patients with an artheriogenic ED (assessed with peak systolic velocity at penile colour doppler ultrasound after PGE1 stimulation, considered normal for data = 25 cm/sec ) were excluded. - We also excluded couples including women with primary sexual dysfunction, as dyspareunia, anorgasmia or vaginismus; substance abuse disorder and/or with significant mental health problems requiring psychotropic drugs. - The presence of substance abuse or mental health problems was assessed by clinical interviews by a mental health specialist. |
Country | Name | City | State |
---|---|---|---|
Italy | Ambulatori Medicina della Sessualità e Andrologia | Florence |
Lead Sponsor | Collaborator |
---|---|
University of Florence |
Italy,
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. — View Citation
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. Androlog — View Citation
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. Epub 2007 Nov 19. Review. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | erectile function | we evaluate change in IIEF-15 erectile function domain from the beginning to the end of treatment (T0 vs.T2) | Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment | |
Primary | overall satisfaction | we evaluate change in IIEF-15 overall satisfaction domain from the beginning to the end of treatment (T0 vs.T2) | Time0= at the beginning of treatment, Time 1 = after 5 weeks of treatment and Time 2= after 10 weeks of treatment |
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