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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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
Sponsor: Eco Fusion

Current Primary Outcome: Global Assessment Profile measured by a survey [ Time Frame: 1 month ]

If the treatment has improved their erectile function


Original Primary Outcome: Same as current

Current Secondary Outcome: Index of Erectile Function measured by a survey [ Time Frame: 1 month ]

if the treatment has improved erectile function


Original Secondary Outcome: Same as current

Information By: Eco Fusion

Dates:
Date Received: April 26, 2016
Date Started: July 2016
Date Completion: December 2016
Last Updated: July 19, 2016
Last Verified: July 2016