Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV) (STEDOV)
Erectile Dysfunction
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, PDE5 inhibitors, Cognitive-behavioral Sex Therapy
Eligibility Criteria
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.
Sites / Locations
- Ambulatori Medicina della Sessualità e Andrologia
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
vardenafil
vardenafil+cbst
The study includes a total period of 10 week with a total of 3 visits for vardenafil Group (at the beginning, at 5th week and at the end). In this study we used Vardenafil 10 mg orodispersible tablets. These are the only orodispersible tablets on commerce indicated for the treatment of ED. Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks.
The study includes a total period of 10 week with a total of 10 visits for vardenafil+cbst Group (one weekly visit). Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks.CBST interventions used in this study includes: psycho-educational interventions on ED maintaining, on anxiety's role and sexual homework. This course is structured in 10 weekly meetings.