# Do you experience a sudden urge to urinate? Do you have an Overactive Bladder (OAB)?

### Purpose of this Urge Urinary Incontinence (UUI) Study

The purpose of this research study is to evaluate the effectiveness of an experimental device (ELITONE-UUI) for urge incontinence. Urge incontinence is when you have a sudden uncontrollable urge to urinate, often called “overactive bladder.” The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.

Are more of your leaks from activities such as sneezing, exercising, or lifting heavy things?  If so, this study is not for you, but check out the original ELITONE.

### The ELITONE Device

The ELITONE device uses surface electrical stimulation. Surface electrical stimulation stimulates the nerves and muscles of the pelvic floor.

The current ELITONE device is already in use for stress incontinence. The only difference between your investigational device and the currently approved device is the muscle stimulating signal that the device delivers. In your device, this signal is specifically designed to treat urge incontinence.

### Study Details

The study is 8 weeks long and completed at home. You will be required to:

1. Keep track of your daily leaks, bathroom visits, and pads worn using an online diary. The first week establishes your baseline and confirms qualifications. You will also complete a pre-study questionnaire.
2. Wear the ELITONE-UUI device 20 minutes a day, 5x per week for 6 weeks. During your treatments, you are free to get dressed and do other activities.
3. At the end of the study you will upload all of your treatment data and complete a post-study questionnaire.

### Is there a cost to participate?

Once eligibility is verified, you will be asked to make a $50 refundable deposit. We will return the$50 back along with the device you used after completing and returning all study materials.  There are no office visits and your insurance company will not be billed.  While we understand this is different than many clinical studies, we have found that the most compliant candidates are ones that have a vested interest in completion. We believe this is a small temporary price for the chance to improve your wellbeing.

### Do You Qualify?

This study is for women with mild-moderate urge urinary incontinence. To see if you qualify:

1. Review and confirm that you DO meet all of the Inclusion criteria
2. Review and confirm that you DO NOT meet any of the Exclusion criteria.

If you believe you qualify and would like to participate, click the link below to take the screening survey. If you qualify we will contact you regarding the next steps.

• A ‘Yes’ answer to “Is it very difficult to control when you have a strong urge to urinate?”
• If you lose urine with physical activities such as coughing, sneezing, running, a ‘Yes’ to “Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing?”
• Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 4)
• Age: 21-80y
• Gender: Female

You will not qualify for the study, if any of these situations below are true.

• Less than 1 incontinence accident (leak) per day*
• Severe incontinence as determined by self-reported >5 accidents per day
• Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks
• Vaginal or pelvic surgery within previous 6 months
• Severe Obesity as defined by BMI >= 35
• Change in incontinence medication type or dosing within the last 3 months.
• History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence
• Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal)
• Tissues protruding outside the vagina at rest
• Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions,
• Complete denervation of the pelvic floor
• Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine,
• Chronic coughing
• Previous use of Interstim device or Botox for UI
• Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
• Cancer, epilepsy or cognitive dysfunction
• Underlying neurologic/neuromuscular disorder
• Impaired decision making, suicidal thoughts, or drug/alcohol dependence
• Lacks capacity to consent for themselves.

* During the baseline week subjects will be excluded if they average less than 1 urge incontinence episode per day (with or without a leak).

### Potential Benefits

We cannot promise any benefits from your taking part in this research. However, possible benefits to you include:

• Reduction of incontinence symptoms and episodes
• Improved quality of life
• Reduction in cost of the symptoms – such as reduction of pads, diapers, laundry, etc.

If you are found eligible to participate in the research study you will be provided additional information and the opportunity to ask any questions you may have. A few of the more common questions include:

The two most common types of incontinence are (1) stress urinary incontinence, which are leaks when you laugh, cough or exercise, and (2) urge urinary incontinence, which is when you have a sudden uncontrollable urge to urinate. With urge incontinence the bladder muscles contract at the wrong times, causing you to have accidents. Urge incontinence is sometimes called “overactive bladder’ and is very common in older adults.  Urge incontinence is typically treated through behavioral modifications, medications, electrical stimulation, or surgery.

If you have urge incontinence, you may qualify for this clinical research study of a new experimental treatment.

After we check the device, we will return the device to you. (Note that the cost of the current ELITONE stress incontinence device is \$399.)

Risks can include:

1. Skin irritation such as redness, itching or sensitivity from the GelPad. This typically disappears after treatment has stopped.
2. Pain or discomfort from pulling of the skin/hair. Applying the GelPad in the correct position and confirming that it is secure and in direct skin contact will help alleviate the pulling and minimize the discomfort.
3. Electrical shock. This is minimized by not using the device while charging and intensity of the shock being controlled by the user.
4. Pelvic muscle fatigue, which may increase urine leakage. If this occurs, it typically resolves after treatment has stopped
5. Fetal unknown risk: This device is not intended to be used in those who are pregnant or planning to become pregnant while in the study. It may harm the fetus in unknown ways.

Prior to starting the study you will receive a consent form that fully describes the study and risks.

You may read the full study consent form here:

ELITONE-UUI_consent_form

Note: Do not sign this copy. If you qualify you will be given an link to sign it digitally.