Title of research study: Sexual dysfunction in patients with postural orthostatic tachycardia syndrome (POTS).
Version Date: February 24, 2022
Investigator: Svetlana Blitshteyn, MD / Director of Dysautonomia Clinic / Clinical Associate Professor of Neurology, University at Buffalo Jacobs School of Medicine
Key Information: The following is a short summary of this study to help you decide whether or not to be a part of this study. More detailed information is listed later on in this form.
Why am I being invited to take part in a research study?
You are being invited to take part in a research study either because you have POTS or because we need representation of people without POTS, for purposes of comparison.
What should I know about a research study?
- Whether or not you take part is up to you.
- You can choose not to take part.
- Your decision will not be held against you.
Why is this research being done?
To gain a better understanding of symptoms of POTS, a syndrome that affects millions.
How long will the research last and what will I need to do?
We expect that this research study will continue for about 7 months. Depending on if you are in the patient or the control group:
- If you are in the patient group, you will be asked to fill out 3 surveys (about 15 minutes total) one time only.
- If you are in the control group, you will be asked to fill out 2 surveys (about 10 minutes total) one time only.
Is there any way being in this study could be bad for me?
There may be a small risk that filling out questionnaires regarding your symptoms could cause psychological or emotional distress.
More detailed information about the risks of this study can be found under “Is there any way being in this study could be bad for me? (Detailed Risks)”
Will being in this study help me in any way?
We cannot promise any other benefits to you or others from your taking part in this research. However, possible benefits to patients include a better understanding of your symptoms of POTS. In addition, the information gathered could provide better direction for POTS treatment in other patients.
What happens if I do not want to be in this research?
Participation in research is completely voluntary. You may choose not to enroll in this study.
Detailed Information: The following is more detailed information about this study in addition to the information listed above.
Who can I talk to?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the research team at [email protected]
This research has been reviewed and approved by an Institutional Review Board (“IRB”). An IRB is a committee that provides ethical and regulatory oversight of research that involves human subjects. You may talk to them at (716) 531-4598 or email [email protected] if:
- You have questions about your rights as a participant in this research
- Your questions, concerns, or complaints are not being answered by the research team.
- You cannot reach the research team.
- You want to talk to someone besides the research team.
- You want to get information or provide input about this research.
What happens if I say yes, I want to be in this research?
You will be shown two or three questionnaires to complete – one (for POTS patients only) to assess the severity of the autonomic dysfunction, one to assess the prevalence/severity of sexual dysfunction, and one to assess for prevalence/severity of depression.
Is there any way being in this study could be bad for me? (Detailed Risks)
There is minimal potential psychological risk that could occur when recalling your symptoms.
This study has been approved by the IRB at University at Buffalo Jacobs School of Medicine.