Incontinence after prostatectomy? Are you interested in speeding recovery and reducing leaks?

At-home Research Study for Urinary Incontinence in Men

Male Incontinence

What if you Could Speed Recovery?

Studies have shown that almost half of men are still wearing pads at 6 months post-surgery. This research study aims to evaluate the Elidah wearable treatment device’s effectiveness in reducing incontinence and pad-use in men post-prostatectomy, and speeding recovery of sexual function, and confidence. The device uses neuromuscular stimulation to externally tone pelvic floor muscles.

Incontinence after prostatectomy affects sexual function.  Did you know that studies show only 14.6% of men could have erections firm enough for intercourse at 12 months post-prostatectomy?1 Unfortunately, recovery of normal urinary control can take 1-2 years in some patients.2

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

Neuromuscular Stimulator

The Elidah device, called Elitone, is FDA-cleared to treat incontinence in women but is investigational 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 signals to stimulate the nerves and muscles of the pelvic floor, doing pelvic floor muscle exercises for you, same as the original Elitone. The difference is that the new GelPad is configured to fit the male anatomy.,

Take the Screening Survey (if within 6 weeks or prior to surgery)

Steps of Study

A: Take the Screening Survey.

B: Qualified candidates will sign a Consent Form.

  • Arm A is within 4 weeks post-prostatectomy (and has a follow-up)
  • Arm B may start after 4 weeks post-prostatectomy. ** CLOSED – this arm is full**

C: Baseline week measurements confirming your incontinence symptoms (questionnaires, record your leaks, bathroom visits, and pad use, and weight of pads within 24-hr period).

D: Treatment for 6 weeks:

  1. Wear the device under clothes (20 min), 5X PER WEEK. You may do other things during this time.
  2. Record your leaks, bathroom visits, and pad use in a daily log.
  3. Upload the daily log ONCE PER WEEK.

E: Repeat the same measurements as baseline week. We will check the data on the device. You do not need to do anything during weeks 7-11.

Followup: At 12 weeks (Arm A required, Arm B optional), there will be a follow-up questionnaire, last week of the log and again weighing of pads.

Male study Schedule
Male GelPad

Do You Qualify?

To see if you qualify, review the Inclusion/Exclusion:

  • Scheduled for or had robotic-assisted laparoscopic prostatectomy?
  • Read and speak English
  • Age: 18-80y
  • Gender: Male
  • 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, or 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 (exclusion for Arm A)
  • Have you had any prior prostate radiation (exclusion for Arm A)
  • 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 if you are eligible. You will then have the opportunity to sign the consent form.

Take the Screening Survey (if within 6 weeks or prior to surgery)

Potential Benefits

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

  • Less pads and other incontinence symptoms
  • Restored sexual function, confidence and quality of life
  • Reduction in cost due to symptoms

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. Feel free to contact us at elidahstudy@gmail.com or customercare@elitone.com. 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.

Yes this is a new option, Arm B. For Arm A, for the quality of the study, we need to compare results from the same starting point which is almost immediately after surgery.

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

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 will receive $100 (up to $250 for Arm A), and be allowed to keep the study device, 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

1.Based on 1643 men in Prostate Testing for Cancer and Treatment (ProtecT) trial (Donovan, et al. Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer. N Engl J Med 2016;375:1425-1437.
2.Van Kampen M, et al. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy” doi: 10.1016/S0140-6736(99)03473-X. PMID: 10675166.

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