Erectile Dysfunction Clinical Trial
Official title:
Satisfaction With the Treatment, Confidence and Naturalness in Engaging in Sexual Activity in Men With Psychogenic Erectile Dysfunction: Randomized Controlled Trial of Three Therapeutic Approaches.
Context and Objectives: Erectile dysfunction severely compromises not only sexual
satisfaction, which is well known to be closely linked to overall life satisfaction but is
also associated with a lower quality of life, lower self-esteem, depression, anxiety and
adverse effects on interpersonal relationships. The objective was to assess the efficacy of
psychotherapy and/or sildenafil for psychogenic erectile dysfunction.
Design and Settings: randomized controlled single-blind trial performed at Institute of
Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil Methods:
Thirty patients with mild and moderate psychogenic erectile dysfunction (ED) were randomized
to receive for six months: group psychotherapy (GP) plus 50mg sildenafil on demand, or 50mg
sildenafil exclusively, on demand, or GP exclusively. Changes in score from baseline for
three questions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were
evaluated at end-point and after 3-months follow-up.
Results: satisfaction with the treatment, confidence and naturalness increased in GP plus
sildenafil and GP exclusively groups (p=0.001) from baseline to endpoint. The
treatment-by-time comparison was not significant at end point versus 3-month follow-ups, in
the three groups. No difference was observed in the sildenafil group in the three study
periods (P >0.05) Conclusions: Patients with mild and moderate psychogenic ED had higher
treatment satisfaction, confidence and naturalness in engaging in sexual activity when
receiving GP plus sildenafil or GP exclusively, when compared with sildenafil exclusively,
as assessed by these three EDITS questions after 6-months treatment
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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