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

NCT01153204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-06-30

No results posted yet for this study

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

BEHAVIORAL

Group Psychotherapy

OTHER

Group Psychotherapy plus Sildenafil citrate

DRUG

Sildenafil citrate

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01153204 on ClinicalTrials.gov