Erectile DysfunctionNCT02757807
Stress Management Using an App to Improve Response With PDE5 Inhibitors in Men With Erectile Dysfunction.
A study testing Utilization of Serenita for Relaxation in people with Erectile Dysfunction, run by Eco Fusion at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Utilization of Serenita for Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Oren Furst, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
RMA
New York, New York, 10025
Oren Fuerst, Ph.D., oren@eco-fusion.com
About this study
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.
Read the 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
- Conditions
- Erectile Dysfunction
- Being tested
- Utilization of Serenita for Relaxation
- Keywords
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utilization of Serenita for RelaxationBehavioural
Users to use Serenita daily and before sexual interaction in order to assess stress and reduce it
| Study group | Role | What they receive |
|---|---|---|
| Utilization of Serenita for Relaxation | Experimental | 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. Receives: Behavioral: Utilization of Serenita for Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Assessment Profile measured by a survey
If the treatment has improved their erectile function
Measured: 1 month
Secondary outcomes (1)
Index of Erectile Function measured by a survey
if the treatment has improved erectile function
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eco Fusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757807
- Sponsor's protocol ID
- 008
- Status last verified
- Jul 2016
- First submitted
- 26 Apr 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management Using an App to Improve Response With PDE5 Inhibitors in Men With Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT02757807
- Acronym / sponsor ID
- 008
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eco FusionIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Utilization of Serenita for Relaxation | Experimental | Behavioral: Utilization of Serenita for RelaxationIntervention 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Utilization of Serenita for RelaxationUsers to use Serenita daily and before sexual interaction in order to assess stress and reduce it | Behavioural | Utilization of Serenita for Relaxation |
Primary outcome
Global Assessment Profile measured by a survey
Time frame: 1 month
If the treatment has improved their erectile function
1 secondary outcome
Index of Erectile Function measured by a survey
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Companys websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Erectile Dysfunction
RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Furst, Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Utilization of Serenita for Relaxation in people with Erectile Dysfunction, run by Eco Fusion at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oren Furst, Ph.D. (oren@eco-fusion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Assessment Profile measured by a survey (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.