Emsella Consent Form

Emsella Consent Form

Client Details
Patient Name

First NameLast Name
Date of Birth

DayMonthYear
Date of birth
Phone Number
Phone number
Email
Email address
Diagnosis
Diagnosis
Treatment Considerations
You are scheduled for a series of non-invasive treatments with the BTL EMSELLA device.

BTL EMSELLA is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.

Your treatment provider will discuss your specific treatment needs. Recommended number of treatments is 6. The treatment is typically about 30 minutes per session, with sessions separated by at least 2 days, depending on your needs. Completing a full treatment series is necessary to maximize treatment efficacy. You may need additional treatments depending on the severity of your condition. The results will typically continue to improve over the next few weeks.

There is typically no pain associated with your treatment and there is no anesthetic required. You will experience gradually increasing tingling feeling and muscle contractions. These sensations in the pelvic area are normal and expected. You remain fully clothed during the treatment.

On the day of the treatment, you are advised to wear comfortable clothes which allow flexibility for correct positioning and increased comfort during the treatment.
Please answer whether you currently have or have had any of the following:

PregnancyCardiac Pacemakersimplanted defibrillators, implanted neurostimulatorselectronic implantspulmonary insufficiencyMetal implantsDrug pumpshemorrhagic conditionsanticoagulation therapyHeart DisordersMalignant TumourFeverAllergy to any medications, food or other substancesTaking prescription, herbal, or over the counter medicationAny surgeriesAny skin disease or sensitivity
If you answered YES to any of these questions, please specify:
List all relevant information
I am aware that pregnancy is contraindicated and pregnant women can’t undergo the treatment.

I am aware that I can’t undergo the treatment when menstruating. Initials:

I understand there are certain risks associated with BTL EMSELLA treatments and they include but are not limited to: muscular pain, temporary muscle spasm, temporary joint or tendon pain, local erythema or skin redness. I understand that the treatment may involve risks of complications or injury from both known and unknown causes, and I freely assume these risks.

I am willing to fill in forms and/or anonymous questionnaires if requested, as this will help for medical evaluation of the results of the treatment. Information will be acquired for medical records or marketing purposes.

I understand the results may vary from person to person and that an exact result cannot be predicted. It is very unlikely but it is possible that you will not feel any recognizable result after the procedure. I acknowledge the results may not meet my expectations.

I certify that I have read this entire document and that I agree with all provisions. I certify that I have had the opportunity to ask questions and these questions have been answered in full to my satisfaction.
I fully understand the treatment conditions, the procedure and possible side effects.

I have read the above information, and I request and give my consent to be treated with the BTL EMSELLA procedure by the physician(s) in the below stated practice and his/her designated staff.
My signature certifies that I have duly read and understood the content of this informed consent form, and have given the accurate information as to my health condition.
Patient Name: Patient Name Date Signed Date
Patient Signature*

Clear
Witness Name: Patient Name Date Signed Date
Witness Signature*

Clear
Practice Name
Name of Practice
Confidential
Many people leak urine some of the time. We are trying to find out how many people leak urine, and how much this bothers them. We would be grateful if you could answer the following questions, thinking about how you have been, on average, over the PAST FOUR WEEKS.
Date of Birth

DayMonthYear
Date of Birth
Are you:

FemaleMale
How often do you leak urine:

neverabout once a week or less oftentwo or three times a weekabout once a dayseveral times a dayall the time
We would like to know how much urine you think leaks. How much urine do you usually leak (whether you wear protection or not)?

nonea small amounta moderate amounta large amount
Overall, how much does leaking urine interfere with your everyday life? Please ring a number between 0 (not at all) and 10 (a great deal)

012345678910
When does urine leak? (Please ring all that apply to you)

never – urine does not leakleaks before you can get to the toiletleaks when you cough or sneezeleaks when you are asleepleaks when you are physically active/exercisingleaks when you have finished urinating and are dressedleaks for no obvious reasonleaks all the time
Thank you very much for answering these questions.

Iciq-ui-questionnaire_A5_EN100
Should be Empty:

Emsella Consent Form

Treatment Considerations

Confidential