Stress Management Using an App to Improve Response With PDE5 Inhibitors in Men With Erectile Dysfunction.
1 other identifier
interventional
100
1 country
1
Brief Summary
The aim of this study is to determine if patients with ED taking PDE5 inhibitors (e.g. Viagra, CIalis, Levitra, Stendra) and experiencing performance anxiety will benefit using a user-friendly stress reducing phone app, Serenita. The study is internet based with no office visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 20, 2016
July 1, 2016
5 months
April 26, 2016
July 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Assessment Profile measured by a survey
If the treatment has improved their erectile function
1 month
Secondary Outcomes (1)
Index of Erectile Function measured by a survey
1 month
Study Arms (1)
Utilization of Serenita for Relaxation
EXPERIMENTALIntervention is that Users continue to take their PDE-5 Inhibitor prior to sexual interaction and IN ADDITION Utilize the Serenita App daily and before any sexual encounters.
Interventions
Users to use Serenita daily and before sexual interaction in order to assess stress and reduce it
Eligibility Criteria
You may qualify if:
- Male ages 18-55 years old
- Persistent mild to moderate ED on PDE5 inhibitors (Viagra, Cialis, Levitra, Stendra)
- Understand English
- Owns smartphone using either iPhone or Android
- Able to understand the use of "Serenita" app
- Willing to use Serenita app before sexual attempt
- Willing to complete all study questionnaires Willing to perform sexual attempt for at least once a week until end of study.
You may not qualify if:
- On testosterone replacement therapy
- History of Peyronie's disease
- Significant cardiac history (uncontrolled hypertension, cardiac arrhythmia, coronary artery disease, coronary bypass surgery)
- Uncontrolled diabetes mellitus
- History of prostate cancer
- Poorly controlled, symptomatic, active medical problems (HIV, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder)
- Neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eco Fusionlead
Study Sites (1)
RMA
New York, New York, 10025, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2016
First Posted
May 2, 2016
Study Start
July 1, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 20, 2016
Record last verified: 2016-07