Electrical Stimulation for Urinary Incontinence

Overseen By Theresa C Cooley Zgela, R.N.

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Disqualifiers: Urinary retention, UTI, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 6 weeks

41 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether a new device, the Elidah Device, can reduce urinary leakage in men who have undergone prostate cancer treatment. The device uses electrical impulses to stimulate pelvic floor muscles, potentially improving bladder control. Men who have experienced moderate urinary incontinence for at least six months after prostate cancer treatment might be suitable candidates for this study. Participants will use the device at home for 20 minutes a day, five days a week, over six weeks, and will keep a log of their experiences. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you should not change any medications prescribed for urinary incontinence within 2 weeks before starting the study.

What prior data suggests that the Elidah device is safe for treating urinary incontinence?

Research has shown that the Elidah device, which uses electrical impulses to stimulate muscles, is based on the ELITONE device. The FDA has already approved the ELITONE device for treating urinary incontinence in women, indicating its safety for use. While the Elidah device is designed for men, the original device's approval provides some confidence in its safety.

Previous studies on similar devices have found them to be generally well-tolerated. Users often report minor side effects, such as mild skin irritation at the application site. These effects are usually not serious and often resolve on their own.

The ongoing trial is in an intermediate phase, meaning the treatment has already passed early safety tests in humans. At this stage, researchers are primarily assessing its effectiveness while still closely monitoring safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Elidah Device is unique because it uses electrical stimulation to address urinary incontinence, offering a non-invasive alternative to traditional treatments like pelvic floor exercises, medications, or surgery. Unlike medications that can have side effects or surgery that requires recovery time, this device aims to directly strengthen pelvic muscles through targeted stimulation. Researchers are excited about its potential to provide a convenient, at-home solution that may offer quicker and easier relief for patients struggling with this condition.

What evidence suggests that the Elidah device is effective for urinary incontinence?

Research shows that the Elidah device, which uses gentle electrical signals, may help reduce urinary incontinence. In earlier studies, women using a similar device experienced 70% fewer leaks and reported improved quality of life. This trial will assess the Elidah device's effectiveness. For men, the device has reduced incontinence and the need for pads after prostate surgery. These findings suggest that the Elidah device could help men manage urinary leakage by strengthening pelvic floor muscles with mild electrical impulses. ^{3 6 7 8 9}

Who Is on the Research Team?

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

Men who have experienced urinary incontinence for at least 6 months following prostate cancer treatment are eligible. They must suffer from stress or urge urinary incontinence, with moderate severity of 1-5 leaks per day and use at least one pad daily. Candidates should be able to read/write English, be over 18 years old, and have a reasonable level of physical fitness.

Inclusion Criteria

Participants must be able to read and write in English.

Ability to understand and the willingness to sign a written informed consent document.

I am male.

Exclusion Criteria

Metal implant in the abdominal or pelvic area.

I plan to change my prostate cancer treatment during the study.

Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including 24-hour pad weight testing and questionnaires relating to incontinence and quality of life

1 week

1 visit (in-person)

Treatment

Participants self-administer the Elidah device treatment for 20 minutes per day, 5 days per week for 6 weeks

6 weeks

2 visits (in-person) at 3 weeks and end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including re-evaluation of symptoms and urinary incontinence via questionnaires and testing with the 24-hour pad weight test

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Elidah Device

Trial Overview The trial is evaluating the Elidah device's effectiveness on male urinary incontinence post-prostate cancer treatment. Participants will use this FDA-cleared electrical stimulation device designed to strengthen pelvic floor muscles at home for six weeks, followed by assessments to measure improvements.

How Is the Trial Designed?

Group I: 1/Elidah Device Experimental Treatment 1 Intervention

Elidah device application.

Elidah Device is already approved in United States for the following indications:

Approved in United States as Elitone for:

• Stress urinary incontinence in women
• Overactive bladder (urge incontinence)

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A modified technique of electrical pelvic floor stimulation was successfully tested on six patients with detrusor urinary incontinence, leading to significant muscle contractions and increased urethral closure pressure.

The percutaneous electrode implantation method is described as easy and noninvasive, showing stable effects on pelvic floor function, making it a promising option for chronic electrical stimulation in treating urinary incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of percutaneous electrode implantation for electrical pelvic floor stimulation. Ishigooka, M., Hashimoto, T., Sasagawa, I., et al.[2019]

Electrical stimulation of the pelvic floor is a safe and well-tolerated treatment for urinary incontinence, showing improvement or cure in over 50% of patients.

Widespread adoption of this inexpensive treatment could enhance patient quality of life and reduce healthcare costs, suggesting it should be more readily available in primary health care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electrostimulation of the pelvic floor. A simple method of treating urinary incontinence]. Schiøtz, HA., Vormdal, J.[2008]

The new device for treating nocturnal enuresis (NE) effectively combines a humidity sensor with electrical stimulation to contract pelvic floor muscles, helping to interrupt urination and teach children to wake up and use the toilet.

In a small study of patients aged 7 to 20, five out of six participants experienced complete resolution of their NE symptoms without any recognizable side effects, demonstrating both the safety and efficacy of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New device and new concept for treating nocturnal enuresis: preliminary results of a phase one study. Barroso, U., Lordêlo, P., Teles, A., et al.[2014]

External electrical stimulation is an effective, noninvasive treatment for stress and idiopathic urge incontinence, with 50%-75% of patients experiencing significant improvement or cure.

The treatment works by stimulating the pudendal nerves, which helps contract pelvic floor muscles and inhibit bladder contractions, and it has minimal adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electrostimulation of the pelvic floor muscles in urinary incontinence]. Tjelum, KB., Lose, G., Abel, I., et al.[2017]

Intravesical electrical stimulation (IVES) using a novel device significantly reduced post-void residual urine volume (PVR) in patients with underactive bladder (UAB) after 4 weeks of treatment, with a mean reduction of -97.1 mL compared to -10.5 mL in the control group (P < 0.01).

The treatment also improved maximum urinary flow rate (Qmax) and bladder voiding efficiency (BVE), indicating enhanced bladder function, while the safety profile was acceptable with only mild urinary tract infections reported and no severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of intravesical electrical stimulation for underactive bladder. Liao, L., Deng, H., Chen, G., et al.[2023]

Electrical stimulation for stress incontinence shows cure rates of 30% to 50% and improvement rates of 6% to 90%, but its clinical use is limited due to a lack of detailed physiological and technical information.

Short-term electrical stimulation with non-implantable electrodes is recommended for its safety and ease of use, with adverse effects occurring in less than 14% of cases, while long-term effects may help re-educate pelvic floor muscles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation for stress incontinence. Yamanishi, T., Yasuda, K.[2019]

In a 7-year study involving women aged 18 to 38, both the levonorgestrel-releasing IUD and the copper IUD demonstrated very low pregnancy rates (0.2/100 women) and low incidence of side effects, including pelvic infections.

The levonorgestrel IUD significantly reduced menstrual bleeding and related conditions compared to the copper IUD, although it was associated with higher rates of certain side effects like amenorrhea and headaches, particularly in younger women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR). Sivin, I., Stern, J.[2022]

Electro-stimulation has been shown to effectively relieve stress and urge urinary incontinence, with cure rates of 30-50% and improvement rates of 60-90%, making it a promising treatment option.

While electro-stimulation is effective, its superiority over other conservative treatments like pelvic floor exercises has not been established, suggesting that combining both methods may provide the best management for stress incontinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical evaluation of electro-stimulation for management of female urinary incontinence. Yasuda, K., Yamanishi, T.[2019]

Nonimplantable electrical stimulators, like the VAGICON-X, are effective rehabilitation aids for correcting urinary incontinence, specifically in patients with stress and urge incontinence.

Preliminary results indicate that anal pressure-controlled electrical stimulation may also benefit patients with stress incontinence, suggesting a promising avenue for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in nonimplantable electrical stimualtors for correction of urinary incontinence. Suhel, P., Kralj, B., Plevnik, S.[2005]

A review of 42 medical device reports on vaginal energy-based devices revealed that most patient complaints, including vaginal pain and urinary symptoms, were not severe, with serious adverse events being rare (only 3.5% reported third-degree burns).

The majority of complaints were reported after the FDA's July 30, 2018 warning, suggesting that increased awareness and potential litigation may have influenced reporting rates, highlighting the need for further research on the safety and efficacy of these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. Wallace, SL., Sokol, ER., Enemchukwu, EA.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04752709

Efficacy of Surface Electrical Stimulation for Urge Urinary ... The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women.

2. elitone.com elitone.com/clinical-study/?srsltid=AfmBOoq2MCGfvDWpZ_QtMN9rfNrjZ8Xa1EmDebDhb3bpXYnwOVS_mp2q

Clinical Study This research study aims to evaluate the Elidah wearable treatment device's effectiveness in reducing incontinence and pad-use in men post-prostatectomy.

3. elitone.com elitone.com/product/elitone-urge/?srsltid=AfmBOopf9nsjS20GFW2337ZCssBBlgKQ6AI6S_nzqOUbXCFW8VnXLK8c

Calm an Overactive Bladder OAB with Elitone URGE Women recorded 70% reduction in leaks improved on all 22 points of the standard Incontinence Quality-of-Life assessment. On average these women had been ...

4. ics.org ics.org/2021/abstract/404

Surface-Applied Electrical Stimulation for the Treatment of ... A successful clinical outcome will expand the use of the ELITONE device beyond its current indication for stress urinary incontinence, providing an opportunity ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03782116

NCT03782116 | Stress Incontinence Trial With Elitone Device Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with mild-moderate stress urinary incontinence. Detailed Description.

6. elitone.com elitone.com/product/elitone-urge/?srsltid=AfmBOoruY6Xw98ntObIIuW8tMh43vumhNlepfzWGj4_oVVQ96s_QyTC2

Calm an Overactive Bladder OAB with Elitone URGE While supplies last. Elitone URGE is FDA-cleared and doctor-recommended, because it is safe and proven, and no one should have to live life around bathroom ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K223884.pdf

K223884 Trade/Device Name: ELITONE - accessdata.fda.gov ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06161506

Surface Electrical Stimulation for Urinary Incontinence in ... The Elidah device is a modified version of the FDA approved ELITONE device cleared for use in the treatment of female stress urinary incontinence. For the ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf18/K183585.pdf

K183585 Trade/Device Name: ELITONE D - accessdata.fda.gov The data included within this submission supports Elitone as a safe and effective Rx and OTC treatment for stress urinary incontinence in women.