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

This study has been completed.
Sponsor:
Collaborator:
Institute of Psychiatry of the Medical School of at Universidade de São Paulo, São Paulo, Brazil
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01153204
First received: June 29, 2010
Last updated: NA
Last verified: June 2010
History: No changes posted
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
Behavioral: Group Psychotherapy
Other: Group Psychotherapy plus Sildenafil citrate
Drug: Sildenafil citrate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Satisfaction with the treatment [ Designated as safety issue: No ]
    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:
  • Confidence in engaging in sexual activity [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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.


Enrollment: 30
Arms Assigned Interventions
Experimental: Group Psychotherapy (GP)
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
Active Comparator: Sildenafil
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
Active Comparator: Group Psychotherapy (GP) plus Sildenafil
The same as above.
Other: Group Psychotherapy plus Sildenafil citrate

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Federal University of São Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT01153204     History of Changes
Other Study ID Numbers: DE Satisfaction - 2010
Study First Received: June 29, 2010
Last Updated: June 29, 2010
Health Authority: Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Erectile Dysfunction
Group Psychotherapy
Sildenafil [Substance Name]
Patient Satisfaction
Efficacy
Randomized Controlled Trial [Publication Type]

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014