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Home»Erectile dysfunction» Searching for men treated with PDE5 inhibitors (such as Viagra or Cialis) and experiencing performance anxiety to test new mobile app
Clinical Trial
Searching for men treated with PDE5 inhibitors (such as Viagra or Cialis) and experiencing performance anxiety to test new mobile app
This trial aims to evaluate if men with erectile dysfunction using PDE5 inhibitors (such as Viagra or Cialis) and experiencing performance anxiety will benefit using a new mobile phone app. The main outcome to be investigated is erectile function. The trial is recruiting online.
The details
Phosphdiesterase-5 (PDE5) inhibitors, such as sildenafil (Viagra) or tadalafil (Cialis), are a well-recognized and effective treatment for erectile dysfunction. PDE5 inhibitors increase blood flow to the penile arteries and help achieve an erection. Many men, however, experience anxiety prior to sexual intercourse. This can make it difficult to maintain an erection despite the use of PDE5 inhibitors.
This study will examine whether a new mobile app, Serenita, can improve erectile function for men treated with PDE5 inhibitors and experiencing performance anxiety. Serenita was designed to detect stress levels and guide the user through relaxation exercises. The app collects data by turning the mobile phone's camera into a biomedical sensor. The sensor obtains data such as heart rate, heart rate variability, and breathing pace. The app then processes the data to assess stress and focus level. This is followed by a range of personalized breathing exercises. A number of online questionnaires will record changes in erectile function, anxiety, sexual encounters, and psychological and interpersonal relationship measures while using the app.
Who are they looking for?
This study will recruit about 100 men between the ages of 18 and 55 with mild to moderate erectile dysfunction. Participants should currently be using PDE5 inhibitors (including Viagra, Cialis, Levitra, or Stendra). All men participating in the trial must own a smartphone (either iPhone or Android) and be able to learn to use the Serenita mobile app. The app must be used before each sexual attempt, at least once a week until the end of the study.
Participants cannot take part in the trial if they are undergoing testosterone replacement therapy. Participants should not have a history of Peyronie’s disease, prostate cancer, or significant heart disease (such as uncontrolled high blood pressure, heart attack, irregular heart rate, or previous bypass surgery). Patients should not have any active infections or malignancies (such as hepatitis, HIV, cancer, or benign prostatic hyperplasia) or present with any significant psychological or neurological disorders.
How will it work
All participants will undergo behavioral therapy with the Serenita mobile app in addition to continued use of PDE5 inhibitors. PDE5 inhibitors and the mobile app should be used before sexual interactions take place. The app should be used daily to assess stress and reduce it. The mobile app should be used prior to a sexual attempt at least once per week until the end of the study (1 month).
6 separate questionnaires will record participants’ responses to therapy for 1 month. These will assess changes in erectile function, anxiety, self-esteem, sexual encounters, and psychological and interpersonal relationship measures.
