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.
NCT number | NCT01153204 |
Other study ID # | DE Satisfaction - 2010 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | June 29, 2010 |
Last updated | June 29, 2010 |
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
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 25 Years to 50 Years |
Eligibility |
Inclusion Criteria: 1. exclusive diagnosis of psychogenic ED, using a checklist for DSM-IV criteria.Morning erections, situational erections (masturbatory or with another partner), or acute onset are characteristics of psychogenic ED; 2. age between 25 and 50 years; 3. mild and moderate erectile dysfunction according to the International Index of Erectile Function (IIEF); 4. stable heterosexual relationship for at least 1 year, and in accordance with inclusion criteria during short-time psychotherapy focused on sexuality; (f) informed consent from the patient. Exclusion Criteria: Patients were excluded if presenting significant clinical diseases, major depressive disorder or other severe mental disorder, primary no erectile sexual disorder (e.g., hypoactive sexual disorder), penile anatomic defects; users of medications that could interfere with sexual function; patients with any kind of physical limitations for the use of sildenafil citrate (current use of nitrates, past history of retinitis pigmentosa, allergies); and significant drug, alcohol or tobacco use |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo | University of Sao Paulo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Satisfaction with the treatment | Changes in scores of EDITS question 1 (satisfaction with the treatment), from baseline to endpoint and 3-months follow-up in the three groups. | No | |
Secondary | Confidence in engaging in sexual activity | Changes in EDITS questions 7 (confidence in engaging in sexual activity) evaluated in three study periods: baseline, end-point and 3-months follow-up in the three groups. | No | |
Secondary | Naturalness in engaging in sexual activity | Changes in EDITS questions 11 (naturalness in engaging in sexual activity), evaluated in three study periods: baseline, end-point and 3-months follow-up in the three groups. | No |
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