Vardenafil and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florence
• Treatments: Vardenafil Dihydrochloride

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.