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

NCT01153204 | Completed Phase 4

• 1 other identifier: DE Satisfaction - 2010
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Group Psychotherapy; Sildenafil [Substance Name]; Patient Satisfaction; Efficacy; Randomized Controlled Trial [Publication Type]

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Confidence in engaging in sexual activity

• Naturalness in engaging in sexual activity

Study Arms (3)

Group Psychotherapy (GP)

EXPERIMENTAL

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.

Behavioral: Group Psychotherapy

Sildenafil

ACTIVE COMPARATOR

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.

Drug: Sildenafil citrate

Group Psychotherapy (GP) plus Sildenafil

ACTIVE COMPARATOR

The same as above.

Other: Group Psychotherapy plus Sildenafil citrate

Interventions

Group Psychotherapy BEHAVIORAL

Group Psychotherapy (GP)

Group Psychotherapy plus Sildenafil citrate OTHER

Group Psychotherapy (GP) plus Sildenafil

Sildenafil citrate DRUG

Sildenafil

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• age between 25 and 50 years;
• mild and moderate erectile dysfunction according to the International Index of Erectile Function (IIEF);

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• University of Sao Paulo: collaborator

Related Publications (1)

• Melnik T, Abdo CH, de Moraes JF, Riera R. Satisfaction with the treatment, confidence and 'naturalness' in engaging in sexual activity in men with psychogenic erectile dysfunction: preliminary results of a randomized controlled trial of three therapeutic approaches. BJU Int. 2012 Apr;109(8):1213-9. doi: 10.1111/j.1464-410X.2011.10516.x. Epub 2011 Aug 22.

  PMID: 22455403 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction; Patient Satisfaction

Interventions

Psychotherapy, Group; Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: June 30, 2010
• Last Updated: June 30, 2010

Record last verified: 2010-06