Stress Management Using an App to Improve Response With PDE5 Inhibitors in Men With Erectile Dysfunction.

Conditions:Erectile Dysfunction
Therapuetic Areas:Nephrology / Urology
Age Range:18 - 55
Start Date:July 2016
End Date:December 2016
Contact:Oren Furst, Ph.D.

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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.

The etiology of erectile dysfunction (ED) has been investigated in many studies. Most often,
ED is proposed to have a multifactorial etiology, with organic and/or psychogenic causal
factors hypothesized to affect erectile function. Numerous studies show that Deep and Slow
Breathing (DSB) reduces stress and anxiety.

Since ED is multifactorial, many physicians rely solely on phosphodiesterase-5 (PDE-5)
inhibitors to increase blood flow to the arteries to maintain an erection. Although it works
in many patients, some patients can get overly anxious prior to sexual intercourse and not
be able to produce or maintain an erection. While some patients may realize that DSB may
improve their anxiety they don't know how to perform DSB properly. We hypothesize that by
providing software interactivity on deep and slow breathing to this group of ED patients,
may in turn help reduce their anxiety, thus, maximize the effect of PDE5 inhibitors. The app
called "Serenita" for mobile phones, designed by Eco-Fusion will be utilized in this study.
The app performs two functions: it detects stress and focus level and It guides the user
through a personalized breathing exercise designed to reduce stress and increase focus.
Breathing as a method to treat stress has three scientifically validated variations, the
deep diaphragmatic breathing, used for centuries as part of Yoga which often refers as Yogic
breathing, biofeedback breathing, a method in which the user sees in real-time how his
breathing affects his stress level, and coherence breathing, a method that synchronizes
breathing pace with heart rhythms. The technology embedded in Serenita app combines all
three methods into a personalized guided breathing regimen. The app acquires data by turning
the mobile phone's camera into a biomedical sensor which peers into a person's blood stream,
obtaining heart rate, heart rate variability and breathing pace. Then the app processes the
data obtained to assess user's stress and focus level.

This study will utilize 6 standardized questionnaires to assess changes in patients'
responses while using the app:

- Erectile Performance Anxiety Index (EPAI), which will ask questions that assess anxiety
about being able to achieve or maintain an erection during sexual activity.

- International Index of Erectile Function (IIEF), which will ask questions about sexual
encounters for the past four weeks.

- Psychological and Interpersonal Relationship Scales (PAIRS), which will ask questions
about sexual self-confidence, time concerns and spontaneity with sexual encounters.

- Self-Esteem and Relationship (SEAR), which will ask questions about sexual
relationship, confidence, stress ad perceived stress and overall sexual relationship
for the past four weeks.

- Sexual Encounter Profile (SEP), which will ask question about each sexual attempt.

- Global Assessment Question, which will ask question at end of study if this app has
improved erectile function.

These questionnaires are conducted online for easy access and completion. There are no
office visits.

Registration to the study could be done at:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
New York, New York 10025
New York, NY
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