Are you scheduled for prostatectomy?  Would you be interested in potentially speeding recovery?

At-home research study for Urinary Incontinence in Men

Male Incontinence

Purpose of this Study

The purpose of this research study is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy. Many men experience persistent urinary incontinence after prostatectomy. The device stimulates the pelvic floor muscles and surrounding structures to improve urinary incontinence.

Incontinence after prostatectomy is usually “stress” incontinence. This type of incontinence happens when the muscles surrounding the urinary valve are not strong enough to keep the valve closed under pressure (lifting heavy things, coughing, exercising, etc.)  Pelvic floor muscle exercises can help strengthen the pelvic floor muscles.

The Elidah Device

The Elidah device, called Elitone, is FDA-cleared to treat incontinence in women. The Elidah device is investigational for men, which means that it is not approved by the Food and Drug Administration (FDA) for men. It is designed to be:

  • 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 a GelPad on your perineum (behind scrotum), and it adheres gently to your skin. Then get fully dressed and put the small controller in your pocket or clip it discreetly to your waistline.

The device works by using electrical neuromuscular stimulation to stimulate the nerves and muscles of the pelvic floor. The controller of the study device sends out identical muscle-stimulating signals as the original Elitone device. The difference is that the new GelPad is configured to fit the male anatomy.

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

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 questionnaires and assessments were completed, and materials were returned
  • Treatment data recorded by the device matches the daily logs

Study Details

Qualified candidates will review and sign a Consent Form to reserve a place. After surgery, when incontinence is confirmed, then you will be enrolled and study materials sent.  Once enrolled and after two-weeks post-prostatectomy, you will complete a few online questionnaires and record your leaks, bathroom visits, and pad use for 7 days. In addition, you will record 3 separate times the weight of pads used within a 24-hr period. This establishes your baseline severity level.  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 questionnaires, record pad weights and return the device. We will check information stored on the device to confirm proper use (no cheating) and then at your option return the device back to you. You do not need to do anything during weeks 7-11.

Following up at 12 weeks, there will be a followup questionnaire, last week of the log and again weighing of pads.

Post-prostatectomy study schedule

Do You Qualify?

This study is for men scheduled for prostatectomy. 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.
  • Scheduled for robotic assisted laparoscopic prostatectomy?
  • Read and speak English
  • Age: 18-80y
  • Gender: Male

Post-op screening:

  • Predominant stress urinary incontinence as determined by responses to a series of three standard questions defined as:
    • An affirmative response to “Do you lose urine with physical activities such as coughing, sneezing, lifting something heavy?”,
    • An affirmative or negative response to “Is it very difficult to control when you have a strong urge to urinate?”,
    • And, if an affirmative response to the second question, an affirmative response to “Are more of your incontinence episodes due to physical activities rather than a strong urge to urinate?”
  • Use of 1 or more pads/day average (also checked from baseline week reporting)

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

  • History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
  • Complete denervation of the pelvic floor
  • Severe Obesity as defined by BMI >= 40
  • Has undergone pre-op pelvic floor exercise strengthening
  • Pelvic pain/painful bladder syndrome
  • Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
  • History of epilepsy
  • Underlying neurologic/neuromuscular disorder
  • Metal implants in the abdomen or pelvic area
  • Chronic coughing
  • Impaired decision making, suicidal thoughts, or drug/alcohol dependence
  • Uncontrolled intercurrent illness that would limit compliance with study requirements
  • Lacks capacity to adhere with study requirements
  • Lacks capacity to consent for themselves.

Click the link to take the screening survey. We’ll let you know right away if you are eligible. Unfortunately, you are not eligible if you already had prostatectomy.

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
  • Faster reduction of incontinence than on your own
  • Improved quality of life
  • Reduction in cost of the symptoms – such as reduction of pads, diapers, laundry, etc.
  • Better understanding of urinary incontinence that may lead to new and improved treatments.

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:

Urinary continence in men is directly related to the internal (smooth muscle) and external (striated) sphincter muscles. The prostate also contributes to increased outlet resistance, especially as men age and the prostate enlarges. After radical prostatectomy, the internal sphincter at the bladder neck is removed and the patient’s continence becomes dependent on the external urinary sphincter. Due to the fact that the external sphincter is a striated muscle it can fatigue, especially after the insult of prostatectomy. Fortunately, the striated muscle can be rehabilitated and strengthened and continence can be improved.

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

Risks can be minimized by following the Instructions for Use (i.e. User Manual).

You may read the full study consent form here:

Post-prostatectomy Consent

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

Unfortunately, for the quality of the study, we need to compare results from the same starting point which is almost immediately after surgery. In the future, once the device is FDA approved the device should be available to you.

No. There will be no placebo devices used. All study participants will receive an active device.