Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)
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|ClinicalTrials.gov Identifier: NCT01153204|
Recruitment Status : Completed
First Posted : June 30, 2010
Last Update Posted : June 30, 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
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Behavioral: Group Psychotherapy Other: Group Psychotherapy plus Sildenafil citrate Drug: Sildenafil citrate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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.|
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
- Satisfaction with the treatmentChanges in scores of EDITS question 1 (satisfaction with the treatment), from baseline to endpoint and 3-months follow-up in the three groups.
- Confidence in engaging in sexual activityChanges 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 activityChanges 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.