FAQ (FREQUENTLY ASKED QUESTIONS)
Why is this study being done?
There are many studies in the medical literature which examine the function of orgasm for men and women, and document that women have fewer orgasms than men.
This has been termed “The Orgasm Gap”. For over a decade there have been studies which examine the role of low intensity shockwave and platelet rich plasma for the purpose of treating erectile dysfunction in men, or for enhancing male erectile function.
There are also many medications which can be used by men to improve erectile function. The same is not true for women. There is no effective “female viagra”, for example.
There are studies of the use of platelet rich plasma injection for female sexual wellness. Results have varied, in part due to lack of standardization or documentation of the platelet dose delivered.
Our study will be measuring the platelet dose delivered in order to better evaluate any proposed benefit. There are no published studies (to our knowledge) of the use of low intensity shockwave therapy to enhance the female sexual experience.
There is one recent study evaluating its use for the treatment of vulvodynia. We believe it is time for equal research attention to be paid to female sexual wellness treatment options.
Have these procedures been performed before?
Yes, as above, these procedures have been performed on women.
They are considered to be “Off Label” because the FDA has not specifically evaluated the procedures as a “treatment” for a specific condition.
What results might I expect from this/these procedure(s)
Yes, as above, these procedures have been performed on women.
They are considered to be “Off Label” because the FDA has not specifically evaluated the procedures as a “treatment” for a specific condition.
Who will see my responses to questionnaires? How is my privacy protected?
Once enrolled you will be assigned a patient number. Your appointments will be booked under that number and your surveys will be identified by patient number as well.
Our statistician is a woman who lives in the Northwest. She will not have access to names of patients.
What are the potential complications from this/these procedure(s)?
Based on our prior experience, as well as available published studies on the use of these devices, we do not expect any significant complications.
With regard to the shockwave treatment, there was a recent study published utilizing this device in the treatment of women with vulvar pain.
The subjects experienced improvement in their pain condition, and there were no complications noted.
You will be given consent forms which outline possible “side effects” of treatment, based on which procedure(s) you elect to have done.
With regard to the PRP injection, we perform this procedure numerous times per month over the past 7 years and have not had anyone with any significant reactions or complications.
There have been prior medical studies conducted which have not shown there to be any significant complications from this PRP procedure which is sometimes referred to as “The O-Shot”.
What if I withdraw from the study?
If you are enrolling in this study, we ask that you be quite certain that you are able to participate until completion of your treatment.
Should you elect to withdraw for any reason we will ask that you let us know the reason for withdrawal so that we can communicate this to our statistician.
There will be no refunds or credits issued for undelivered services
How long will the study take?
There are 6 procedure visits, scheduled about 7 to 10 days apart.
The first visit may be up to 90 minutes. Subsequent visits will likely be under 40 minutes.
Surveys completed outside of the MediSpa will be at 3 months, 6 months, and possible 12 months post final procedure and should take no more than 30 minutes each time
Will I be informed of the study results
You will be notified when the study has been published.
Redefine The Way You Age to Look and Feel Your Best
Redefine The Way You Age
to Look and Feel Your Best
AT LAST! A SOLUTION FOR SEXUALLY
ACTIVE ADULT (AGE 21+) WOMEN
Apply to Participate in Women’s Sexual Wellness Study
Who is this for?
For sexually active adult women (age 21+) who are interested in:
- Enhancing sexual function and/or
- Who have current difficulty achieving orgasm
Why?
Traditionally, the focus has always been on male sexual function and performance. We believe that it's time to pay equal attention to women, who can also experience difficulty due to changes in sensation, lubrication and blood flow.
Where?
Renew MediSpa Training Institute (separate entrance from MediSpa), 23B Crystal Avenue, Derry, NH 03038.
HOW DOES THIS SEXUAL WELLNESS STUDY WORK?
Study design: A Prospective Cohort Observational Study of the Effect of Focused Low Intensity Shockwave Therapy “FemiWave” with or without Platelet Rich Plasma on Female Orgasm
Location: Renew MediSpa Training Institute, 23B Crystal Avenue, Derry, NH 03038
Principal Investigator: Lisa Vuich, MD
Team Members:
- Heather Dozois, NP
- Tracey Decker, assistant
WHO IS THIS FOR?
- Sexually active adult women age 21+ who are interested in enhancing orgasm and/or who have current difficulty achieving orgasm.
- No specific “diagnosis” is required as this study will evaluate change from baseline.
- We welcome participants of all races, socio-economic backgrounds and sexual orientations.
WHO IS THIS NOT FOR?
- Current victim of Domestic Abuse/Partner Violence
- Significantly impaired immune system: ex: on Immunosuppressant medication, Chemotherapy
- Current use of prescription blood thinners such as Coumadin/warfarin/Plavix, etc... or those with bleeding disorders
- Not sexually active
- Unstable psychological illness; or Active Substance Abuse (Drugs, Alcohol)
- Pregnant or attempting to become pregnant
WHAT IS FEMIWAVE
A term often used for the non-invasive application of low intensity shockwave treatment (LiSWT) to the external female genitalia for the purpose of enhancing sensation, tissue health and blood flow.
The device used is the same type used to treat erectile dysfunction in men. The procedure requires no numbing and is not considered to be painful.
A recent study demonstrated safety of this type of device in this region for the treatment of Vulvodynia (click here to open the PDF in a new tab). Renew MediSpa has been offering LiSWT since 2016.
Platelet Rich Plasma (PRP): A concentration of your own platelets, which contain your natural growth factors, derived from a blood draw obtained from you at your first visit and processed using a sterile, FDA approved kit.
After adequate numbing, the PRP is then injected into the genital regions to promote tissue health/regeneration. Renew MediSpa has been offering this treatment since 2015.
The use of LiSWT and PRP for female sexual wellness has not been evaluated by the FDA as a treatment for specific disorders- this use is thus described as “Off Label Use”. However, the devices we use are all FDA cleared for use on human subjects.
COST & BENEFITS OF PARTICIPATING
Participants will receive a 20% discount ($420) off the regular price ($2100) of the services rendered.
You can earn an additional $100 gift card for each follow up survey you complete (3, 6, and 12 month follow up surveys= $300 money back).
This reduces the final investment to $1380.
Payment in full (regular price minus 20% = $1680) is required in advance to schedule the treatments.
We do not bill insurance but can provide any documentation required regarding charges if you wish to submit it yourself.
We do accept Flex Spending Account and Health Savings account processed payments.
Surveys which will be used to follow response to treatment can be provided upon request.
We will have Day, Evening and Saturday appointments available.
REQUIREMENTS
- Fill out the application through a secure HIPAA compliant form or print it out and return in a sealed envelope
- Participants will have 6 visits to Renew MediSpa Training Institute for active treatment
- First visit approximately 1.5 hours; paperwork, FemiWave treatment, (PRP injection if desired)
- Visits 2 through 6 approximately 7 to 10 days intervals, approximately 30 minutes (Femiwave only)
- Surveys to be completed and submitted or completed electronically: during visits, and at 3, 6 and 12 months post treatment (if you submit this timely each time you will get a $100 gift card for each survey you submit)
INTERESTED?
Start the application process or open a live chat with any questions or concerns right now. Or call us during business hours.
(*) for more info on our regular services, call, text or visit our website: https://www.renewmedispa.com/
Copyright 2022 - Renew MediSpa - 23 B Crystal Ave Derry 03038 (exit 4 , off route 93) - Privacy Policy - No Show Policy