The use of microcurrent bioelectric stimulation to reverse erectile dysfunction

CONSENT FORM

 

Erectile dysfunction (ED) affects up to 20% of men, an increasing problem with advancing age. There are many contributing causes of ED, including concomitant use of prescribed medications for health problems (such as hypertension medication), or causal diseases such as diabetes, high cholesterol, coronary artery disease, and obesity. It is a global health problem. Although erectile dysfunction does not present risks to the individual's life, it can provoke a series of disorders, such as decreased self-esteem, increased anxiety, social relationship impairment, and depression, among others.

You have been diagnosed with ED and have been invited to participate in a voluntary clinical study to evaluate the benefit of microcurrent bioelectric stimulation to reverse erectile dysfunction. This trial involves a single treatment arm and no placebo.

We inform you that you will receive a treatment in which an electric stimulus will be applied to your penis. You may feel a tingling sensation in the region of the penis, and may or may not have an erection during or after treatment. At any time, you can request discontinuation of the treatment, which should last four weeks, twice a week, with 30-40 minutes of electrical stimulation applied each session. You will also be asked to complete questionnaires at the beginning and end of the treatment which are important goals of the study. Possible benefits to you include the potential for significant improvement of your erectile function.

This study is a collaboration between Dr. Amy Killen of Biorestoration and MyoStim ED, creators of the Erectistim protocol. Similar studies have been done in the past by Dr. Cristiane Carboni in Brazil, during which none of the 105 participants experienced significant negative side effects. Shannan Story, Dr. Killen’s Medical Assistant, will be administering the bioelectric stimulation to patients in this study. Shannan will also be corresponding with patients and will work with Dr. Killen to compile the necessary data.

You qualify for participation in this study because of the diagnosis of ED. Your participation is totally voluntary, and not participating will not cause any penalty to you or adversely affect your care or cause any loss of benefits. This is a research study, and the results of all patients that participate will be collected in a manner that will prevent the identification of your name or identity. This data will be used to demonstrate the overall benefit of the use of microcurrent bioelectric stimulation to reverse erectile dysfunction and will be published in medical journals and potentially presented at medical meetings to help educate providers about the added benefit of this approach. You can elect to discontinue participation in this study at any time.

After reading the terms and being guided by the researcher, I affirm that I have accepted to participate of my own free will, without receiving any financial incentive and with the exclusive purpose of collaborating for the success of the research. I received information about the strictly academic objectives of the study, where the results will be used in special situations, as in scientific publications, and at the end of the research, the data will be kept confidential.

I was offered a signed copy of this Consent Form, as recommended by the Research Ethics Committee. My collaboration will be done anonymously. The access and analysis of the data collected will be done only by the researcher and/or her assistant. I am aware that I am not obliged to answer the questions asked in the evaluation questionnaire and, if I have questions or feel impaired, I can contact the researcher responsible or her assistant. I also have free will to withdraw from this research at any time, without prejudice to my follow-up or suffer any sanctions or constraints.

If I have questions at any time along the way, I can contact Dr. Amy Killen at amykillenmd@gmail.com or Shannan Story at Shannan@biorestoration.com. I can call Biorestoration Medical Clinic at 801-501-9797 to make or change appointments.