Do you experience a sudden, uncontrollable urge to urinate?  Can’t go too far from a bathroom?

At-home research study for Urge Urinary Incontinence

incontinence 1

Purpose of this Study

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

If your leaks are caused by sneezing, coughing, laughing, exercising, or lifting heavy things, then you have “stress” incontinence, and this study is not for you.  Please check out the original ELITONE which is FDA-cleared to treat stress incontinence and available without prescription.

The ELITONE-UUI Device

The ELITONE-UUI device (study device) is similar to the original ELITONE.  Both devices are:

  • Easy to Use: Treatment only takes 20 minutes a day and you can wear it while you go about your normal day. You simply Apply, Adjust, and Wear.
  • External: You apply where you would put a pad, but adhered gently to your skin. Then get fully dressed and put the small controller in your pocket or clip it discreetly to your waistline.

Both devices work by using electrical stimulation to stimulate the nerves and muscles of the pelvic floor. The only difference between the study device and the original device is the muscle-stimulating signal that each device delivers. The study device outputs a signal specifically designed to treat urge incontinence.

ELITONE is an external Kegel Exerciser to stimulates pelvic floor muscles to reduce urinary leaks

Is There a Cost/Compensation to Participate?

There are no office visits and your insurance company will not be billed. You may incur unexpected expenses from participation in this study.

For taking part in this research, you may be paid $100, and allowed to keep the study device. Compensation will be paid only after all study requirements have been met, including:

  • The device was used according to the instructions
  • All daily logs were maintained and returned
  • All pre- and post-study materials were returned
  • Treatment data recorded by the device matches the daily logs

Study Details

Qualified candidates will review and sign a Consent Form prior to being enrolled. Once enrolled you will complete a pre-study questionnaire that details your experience with urinary incontinence. You will also record your leaks, bathroom visits, and pad use for 7 days. This establishes your baseline severity level. After confirming your eligibility you will be sent the ELITONE-UUI device. For the next 6 weeks you will:

  1. Wear the device 20 minutes a day, 5X PER WEEK. During these treatments you are free to get dressed and do other activities.
  2. Record your leaks, bathroom visits, and pad use in a daily log. You need to do this EVERY DAY.
  3. Upload the daily log ONCE PER WEEK. This allows us to make sure everything is going smoothly for you.

After 6 weeks you will complete an additional questionnaire and return the device. We will check information stored on the device to confirm proper use (no cheating) and then process your compensation.

UUI Protocol Chart

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.

NOTE: This study is not available to women who are using or have previously used the ELITONE device.

  • 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
  • Pelvic pain/painful bladder syndrome
  • 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).

**Enrollment is closed.

Click the link to take the screening survey. We’ll let you know right away if you are eligible.

UPDATE: We are currently only recruiting women with pure urge incontinence. If you have have symptoms of stress incontinence (leaking when you laugh, sneeze, exercise) in addition to urge incontinence you are not eligible to participate at this time.

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.

Frequently Asked Questions

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 is 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.

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 a link to sign it digitally.

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