Clinical Trials Directory

Trials / Completed

CompletedNCT01153204

Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)

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.

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Federal University of São Paulo · Academic / Other
Sex
Male
Age
25 Years – 50 Years
Healthy volunteers
Not accepted

Summary

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

Conditions

Interventions

TypeNameDescription
BEHAVIORALGroup Psychotherapy
OTHERGroup Psychotherapy plus Sildenafil citrate
DRUGSildenafil citrate

Timeline

First posted
2010-06-30
Last updated
2010-06-30

Source: ClinicalTrials.gov record NCT01153204. Inclusion in this directory is not an endorsement.