Erectile DysfunctionPhase 4NCT01153204
Satisfaction, Confidence and Naturalness in Men With Psychogenic Erectile Dysfunction (ED)
A Phase 4 study testing Group Psychotherapy, Group Psychotherapy plus Sildenafil citrate and Sildenafil citrate in people with Erectile Dysfunction, run by Federal University of São Paulo.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Group Psychotherapy, Group Psychotherapy plus Sildenafil citrate and Sildenafil citrate
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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);
- 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.
Who cannot join
- 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
About this study
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.
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
- Being tested
- Group Psychotherapy, Group Psychotherapy plus Sildenafil citrate, Sildenafil citrate
- Keywords
- Erectile Dysfunction, Group Psychotherapy, Sildenafil [Substance Name], Patient Satisfaction, Efficacy, Randomized Controlled Trial [Publication Type]
- Medical subject headings
- Erectile Dysfunction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group PsychotherapyBehavioural
Group Psychotherapy plus Sildenafil citrateOther
Sildenafil citrateDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sildenafil citrate |
| Group Psychotherapy (GP) plus Sildenafil | Active comparator | The same as above. Receives: Other: Group Psychotherapy plus Sildenafil citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153204
- Sponsor's protocol ID
- DE Satisfaction - 2010
- Status last verified
- Jun 2010
- First submitted
- 29 Jun 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22455403
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01153204
- Acronym / sponsor ID
- DE Satisfaction - 2010
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Group Psychotherapy, Sildenafil [Substance Name], Patient Satisfaction, Efficacy, Randomized Controlled Trial [Publication Type]
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- First posted
- 30 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Psychotherapy (GP) | Experimental | Behavioral: Group PsychotherapyTime-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 | Active comparator | Drug: Sildenafil citrateParticipants 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 | Active comparator | Other: Group Psychotherapy plus Sildenafil citrateThe same as above. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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);
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Psychotherapy | Behavioural | Group Psychotherapy (GP) |
| Group Psychotherapy plus Sildenafil citrate | Other | Group Psychotherapy (GP) plus Sildenafil |
| Sildenafil citrate | Drug | Sildenafil |
Primary outcome
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.
2 secondary outcomes
Confidence in engaging in sexual activity
Naturalness in engaging in sexual activity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Derived from this study: PubMed 22455403Melnik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group Psychotherapy, Group Psychotherapy plus Sildenafil citrate and Sildenafil citrate in people with Erectile Dysfunction, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01153204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010; AzTrials last refreshed its copy on 6 Nov 2026.