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Mindfulness-Based Therapy for Erectile Dysfunction (PRIMED Trial)

N/A
Recruiting
Led By Miriam Driscoll, MD
Research Sponsored by Vancouver Coastal Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
19 years of age or older
Diagnosed with situational erectile dysfunction (ED) of at least 6 months duration, as assessed by a physician at the BC Centre for Sexual Medicine according to DSM-5 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to four months post-treatment (22 weeks)
Awards & highlights

PRIMED Trial Summary

This trial will test if a 6-session mindfulness-based therapy group will help men with erectile dysfunction who have poor adherence to pharmacological treatments.

Who is the study for?
This trial is for men over 19 with situational erectile dysfunction (ED) lasting at least 6 months, who are comfortable in small groups and can communicate in English. Participants must not use ED medications from the start until 10 weeks into the study and should have no unmanaged health or severe mental conditions.Check my eligibility
What is being tested?
The trial tests a mindfulness-based psychosexual therapy (MBPST) across six sessions to see if it helps men with situational ED. It builds on a previous successful protocol, measuring outcomes through questionnaires about sexual function, relationship satisfaction, and treatment acceptability.See study design
What are the potential side effects?
Since MBPST involves psychological therapy rather than medication, typical side effects associated with drugs may not apply. However, participants might experience emotional discomfort or distress during therapy.

PRIMED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 19 years old or older.
Select...
I have been diagnosed with situational ED for at least 6 months.

PRIMED Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to four months post-treatment (22 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to four months post-treatment (22 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self-reported Confidence in Sexual and Erectile Competence as measured by Sexual Self-Efficacy Scale - Erectile Functioning
Self-reported Erectile Functioning as measured by International Index of Erectile Function - 5
Self-reported Sexual Distress as measured by Sexual Distress Scale-Revised
+3 more
Secondary outcome measures
Anxiety Symptoms as measured by Generalized Anxiety Disorder-7
Degree of Mindfulness as measured by the Five Facet Mindfulness Questionnaire-15
Non-attachment mindfulness skill as measured by Nonattachment Scale-7
+1 more
Other outcome measures
Mindfulness and Sexual Activities Practice as measured by investigator-created questionnaire
PDE5 inhibitor Medication Use
Patient Satisfaction towards therapy group and Self-reported Impact on Quality of Sexual Life as measured by Patient Global Impression of Change Scale - Revised

PRIMED Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Patients are compared to themselves before and after the treatment.

Find a Location

Who is running the clinical trial?

Vancouver Coastal HealthLead Sponsor
38 Previous Clinical Trials
716,852 Total Patients Enrolled
Miriam Driscoll, MDPrincipal InvestigatorUBC

Media Library

Mindfulness based psychosexual therapy ( MBPST) Clinical Trial Eligibility Overview. Trial Name: NCT04341025 — N/A
Erectile Dysfunction Research Study Groups: Single Arm
Erectile Dysfunction Clinical Trial 2023: Mindfulness based psychosexual therapy ( MBPST) Highlights & Side Effects. Trial Name: NCT04341025 — N/A
Mindfulness based psychosexual therapy ( MBPST) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04341025 — N/A
~5 spots leftby Dec 2024
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