Electrical Stimulation for Urinary Incontinence

Overseen By Theresa 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

Trial Summary

What is the purpose of this trial?

Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help. Objective: To see if the Elidah device can reduce urinary incontinence after prostate treatment. Eligibility: Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer. Design: Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests. The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis. Participants will be given an Elidah device and taught how to use it at home. They will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks. Participants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads. Participants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used. Participants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment. Participants will complete 15-minute questionnaires.

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.

Is electrical stimulation for urinary incontinence safe?

Electrical stimulation for urinary incontinence is generally considered safe, especially when using non-implantable electrodes for short-term treatment, with adverse effects occurring in less than 14% of cases. However, there may be some risks like infection, pain, and bleeding, particularly with implantable electrodes. ^{1 2 3 4 5}

How is the Elidah Device treatment different from other treatments for urinary incontinence?

The Elidah Device, used for electrical stimulation, is unique because it offers a noninvasive and simple way to treat urinary incontinence by stimulating the pelvic floor muscles, which can be done at home or in a clinical setting. This method is effective for both stress and urge incontinence and is a cost-effective alternative to more invasive procedures or drug therapies. ^{6 7 8 9 10}

Research Team

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vaginal energy-based devices: characterization of adverse events based on the last decade of MAUDE safety reports. [2021]

2. England pubmed.ncbi.nlm.nih.gov

New device and new concept for treating nocturnal enuresis: preliminary results of a phase one study. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of intravesical electrical stimulation for underactive bladder. [2023]

4. United States 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). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Electrical stimulation for stress incontinence. [2019]

6. Norway pubmed.ncbi.nlm.nih.gov

[Electrostimulation of the pelvic floor. A simple method of treating urinary incontinence]. [2008]

7. Denmark pubmed.ncbi.nlm.nih.gov

[Electrostimulation of the pelvic floor muscles in urinary incontinence]. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Critical evaluation of electro-stimulation for management of female urinary incontinence. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Technique of percutaneous electrode implantation for electrical pelvic floor stimulation. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Advances in nonimplantable electrical stimualtors for correction of urinary incontinence. [2005]