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

July 19, 2016 updated by: Eco Fusion
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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: http://eepurl.com/b3DcP1

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Utilization of Serenita for Relaxation
Intervention 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.
Behavioral: Utilization of Serenita for Relaxation
Users to use Serenita daily and before sexual interaction in order to assess stress and reduce it

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment Profile measured by a survey
Time Frame: 1 month
If the treatment has improved their erectile function
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Index of Erectile Function measured by a survey
Time Frame: 1 month
if the treatment has improved erectile function
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eco Fusion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (ESTIMATE)

May 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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