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

Phase 4

Completed

• Conditions: Erectile Dysfunction
• Interventions: Behavioral: Group Psychotherapy; Drug: Sildenafil citrate; Other: Group Psychotherapy plus Sildenafil citrate

• Registration Number: NCT01153204
• Lead Sponsor: Federal University of São Paulo

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-29
• Last Update Submitted: 2010-06-29
• Study First Posted: 2010-06-30
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Psychotherapy (GP)	Group Psychotherapy	Time-limited group psychotherapy is a technique based on psychodrama, an in-depth method of group psychotherapy. Active methods are used to enable past, present, and future life events to be explored. Sexual issues and their possible solutions are enacted rather than simply discussed. Time-limited group psychotherapy focuses on a central or core issue or a circumscribed area of conflict (psychogenic erectile dysfunction) as the only or major object of intervention efforts.
Sildenafil	Sildenafil citrate	Participants took sildenafil citrate 50 mg as needed for sexual activity (on demand), no more than once daily, according to psychiatric prescription. Sildenafil citrate was taken with a glass of water on an empty stomach (at least 2 hours after eating). Participants met with a psychiatrist every month for 30-minutes to report adverse effects and to obtain the following month's dosage of four pills.
Group Psychotherapy (GP) plus Sildenafil	Group Psychotherapy plus Sildenafil citrate	The same as above.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.