Electrical Stimulation for Urinary Incontinence

Overseen By Gloria Kolb, MS MBA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Elidah, Inc.

Disqualifiers: Urinary incontinence, Obesity, Heart problems, Epilepsy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment using electrical stimulation can reduce urinary incontinence (loss of bladder control) in men who have undergone prostate surgery. Participants will use a device that delivers a mild electrical pulse to strengthen the muscles involved in bladder control. Ideal candidates are men scheduled for prostate surgery who currently use at least one pad a day for stress incontinence. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future treatments for urinary incontinence.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What prior data suggests that this electrical stimulation is safe for urinary incontinence treatment?

Research has shown that electrical stimulation on the perineal area is generally well-tolerated. One study focused on devices using electrical stimulation to treat stress urinary incontinence, a condition involving loss of bladder control. This study found these devices safe and effective in strengthening pelvic muscles. Another study examined similar devices and reported no serious safety concerns. Most participants experienced no significant side effects, and any discomfort was typically mild.

Overall, while further research is beneficial, current studies suggest this treatment is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about perineal-applied electrical stimulation for urinary incontinence because it offers a non-invasive and self-managed option, unlike traditional treatments like medications or surgeries. Most treatments rely on oral drugs that can have side effects or require surgical interventions, which come with risks and recovery time. This new method uses electrical stimulation applied externally, providing a potentially safer and more convenient alternative for patients. Additionally, it empowers individuals to manage their symptoms independently at home, which could improve adherence and outcomes.

What evidence suggests that perineal-applied electrical stimulation is effective for urinary incontinence?

Research has shown that electrical stimulation on the perineal area can help reduce urinary symptoms. Studies have found that this method strengthens pelvic floor muscles, improves quality of life, and increases satisfaction. Specifically, neuromuscular electrical stimulation (NMES) effectively treats lower urinary tract problems. A review of multiple studies also supports combining electrical stimulation with pelvic exercises to reduce the severity of urinary incontinence. These findings suggest that electrical stimulation, which participants in this trial will self-apply for six weeks, could be a promising option for managing urinary incontinence in men after prostate surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Gloria Kolb, MS,MBA

Principal Investigator

Elidah, Inc.

Are You a Good Fit for This Trial?

This trial is for men who are experiencing incontinence, specifically after having surgery to remove the prostate (post-prostatectomy). The study aims to help those struggling with bedwetting or urinary incontinence.

Inclusion Criteria

I am scheduled for a robotic-assisted surgery to remove my prostate.

I use at least one pad a day due to urine leakage.

Exclusion Criteria

Has undergone pre-op pelvic floor exercise strengthening

History of epilepsy

Impaired decision making, suicidal thoughts, or drug/alcohol dependence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-apply electrical stimulation for 6 weeks to reduce incontinence

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Perineal-applied electrical stimulation

Trial Overview The trial is testing a treatment called Elidah neuromuscular stimulation. It involves applying electrical stimulation externally at the perineum area to see if it can reduce symptoms of incontinence.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

Self-applied electrical stimulation for 6 weeks.

Perineal-applied electrical stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Electrical Stimulation for:

• Urinary incontinence
• Overactive bladder
• Stress urinary incontinence

Approved in European Union as Electrical Stimulation for:

• Urinary incontinence
• Overactive bladder
• Stress urinary incontinence
• Faecal incontinence

Who Is Running the Clinical Trial?

Elidah, Inc.

Lead Sponsor

Trials

4

Recruited

210+

Published Research Related to This Trial

A portable electrical stimulation system applied to the pelvic floor muscles showed significant improvement in urinary incontinence for five out of six patients after 4-8 weeks of treatment.

The treatment increased the detrusor reflex threshold and reduced involuntary bladder contractions without any reported complications, making it a promising option for patients who do not respond well to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical pelvic floor stimulation in the management of urinary incontinence due to neuropathic overactive bladder. Ishigooka, M., Hashimoto, T., Izumiya, K., et al.[2006]

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]

The vaginal epithelium is a crucial barrier against infections, but it can be damaged by mechanical or chemical irritants, increasing susceptibility to infections, highlighting the need for safe products applied to this area.

Current testing methods for vaginal mucosal irritation, such as the in vivo rabbit test, are being replaced by alternative in vitro methods that align with ethical standards and European regulations, ensuring the safety of personal care products without using animal testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vaginal irritation models: the current status of available alternative and in vitro tests. Costin, GE., Raabe, HA., Priston, R., et al.[2019]

Tazarotene foam 0.1% was found to cause more irritation than the vehicle foam and controls in a study with 14 participants (36%) experiencing mild and transient application-site adverse events.

The foam showed a low potential for contact sensitization, with only questionable reactions observed in three participants, indicating an acceptable safety profile for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Berg, JE., Bowman, JP., Saenz, AB.[2014]

In a study of 20 patients with refractory postencephalitic epilepsy (PEE) who underwent vagus nerve stimulation (VNS), significant reductions in seizure frequency were observed, with median seizure reduction rates increasing from 23.72% at 3 months to 67.99% at 12 months post-treatment.

VNS demonstrated a good safety profile, with no intraoperative complications or severe postoperative adverse effects reported, indicating its potential as a viable treatment option for patients with refractory PEE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus Nerve Stimulation Therapy for the Treatment of Seizures in Refractory Postencephalitic Epilepsy: A Retrospective Study. Sun, Y., Chen, J., Fang, T., et al.[2022]

In a study of 14 epilepsy patients treated with vagus nerve stimulation (VNS), the loss of seizure control and irregular stimulation perception were key indicators of end of effective stimulation (EOES) or end of battery life (EOBL), suggesting that these factors are critical for monitoring VNS effectiveness.

Delaying the replacement of the VNS generator after EOES or EOBL can lead to permanent loss of seizure control, highlighting the importance of timely generator replacement to maintain treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Generator replacement in epilepsy patients treated with vagus nerve stimulation. Vonck, K., Dedeurwaerdere, S., De Groote, L., et al.[2014]

In a pilot study involving 20 patients with refractory epilepsy, the VNS Therapy Demipulse Model 103 significantly reduced mean monthly seizure frequency from 54 to 33 seizures after one year, with 39% of patients experiencing a reduction of over 50%.

The treatment was generally well tolerated, although some side effects were reported, including throat tingling and hoarseness, and one case of sudden unexpected death in epilepsy (SUDEP).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution in VNS therapy for refractory epilepsy, experience with Demipulse devices at Ghent University Hospital. El Tahry, R., De Herdt, V., Raedt, R., et al.[2014]

In a study of 43 adult patients who had been using vagus nerve stimulation (VNS) for over 2 years, nearly half (49%) reported no clear benefit from the treatment and chose to stop using it, indicating that VNS may not be effective for everyone.

Patients who did not perceive a benefit from VNS had received more new antiepileptic drugs during treatment compared to those who did report benefits, suggesting that the effectiveness of VNS may be confounded by other treatments and the natural progression of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy patients with and without perceived benefit from vagus nerve stimulation: A long-term observational single center study. Brodtkorb, E., Samsonsen, C., Jørgensen, JV., et al.[2020]

Before using a new topical product on diseased skin, it is crucial to first assess its safety on healthy skin in human volunteers.

The paper outlines guidelines for evaluating potential skin irritation, sensitization, phototoxicity, and photoallergy of topical products, emphasizing the need for a structured safety evaluation approach since current studies lack regulatory oversight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical trials in dermatology. The phase I trials]. Czernielewski, J., Queille-Roussel, C., Duteil, L., et al.[2013]

In a study extension involving 27 male subjects, a pulsed electrical stimulation device showed significant efficacy in increasing terminal hair counts, with the active treatment group experiencing an increase from 82 to 276 hairs over 70 weeks.

The crossover group also demonstrated hair count improvements, rising from 160 to 249 hairs after switching from sham to active treatment, indicating the device's effectiveness and safety during extended use, although the small sample size limits the generalizability of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrotrichogenesis: further evidence of efficacy and safety on extended use. Maddin, WS., Amara, I., Sollecito, WA.[2019]

In a study of 26 patients with refractory epileptic encephalopathies, vagus nerve stimulation (VNS) significantly improved seizure control, with at least a 50% reduction in seizure frequency observed in 17 out of 20 patients with Lennox-Gastaut syndrome and in some patients with Dravet syndrome and epilepsy with myoclonic-astatic seizures.

VNS was well-tolerated and not only reduced seizures but also improved quality of life and neuropsychological performance over a treatment duration of up to 36 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagus nerve stimulation: effectiveness and tolerability in patients with epileptic encephalopathies. Cersósimo, RO., Bartuluchi, M., De Los Santos, C., et al.[2021]

A novel externally applied neuromuscular electrical stimulation (NMES) device significantly reduced leakage in women with stress urinary incontinence (SUI), showing an impressive 97.71% decrease in leakage after eight weeks of treatment.

The study involved nine women who used the device at home for 30 minutes, four times a week, and demonstrated improvements in pelvic floor muscle contractions and overall muscle strength, indicating that NMES can be an effective noninvasive treatment for SUI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel externally applied neuromuscular stimulator for the treatment of stress urinary incontinence in women--€”a pilot study. Maher, RM., Caulfield, B.[2022]

In a study of 25 patients with stress urinary incontinence, perineal electrical stimulation showed positive results in 52% of cases, indicating its potential effectiveness as a treatment option.

Specifically, 66% of patients who experienced urinary incontinence after prostate surgery responded positively to this treatment, suggesting it could be a viable alternative before considering more complex therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of perineal electric stimulation in stress urinary incontinence]. Salinas Casado, J., Varela, E., Prieto Chaparro, L., et al.[2007]

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]

A global recall of Roche's nelfinavir mesylate (Viracept) was initiated due to elevated levels of the mutagen ethyl methanesulfonate (EMS), but animal studies indicated that the levels patients were exposed to were significantly lower than those causing toxicity.

Comprehensive toxicology evaluations showed that patients taking nelfinavir mesylate are not at increased risk for cancer or birth defects, as the doses of EMS they received were far below the levels required to cause DNA damage or mutations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elevated ethyl methanesulfonate (EMS) in nelfinavir mesylate (Viracept, Roche): overview. Pozniak, A., Müller, L., Salgo, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271381/

Effects of external neuromuscular electrical stimulation in ... External NMES was an effective and complementary method in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, and satisfaction level in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39033475/

Effects of external neuromuscular electrical stimulation in ... Conclusions: External NMES was an effective and complementary method in reducing urinary symptoms and improving PFMS, QoL, sexual function, PSI, ...

3. nature.com nature.com/articles/s41598-024-78358-7

Comparison of nonimplantable electrical stimulation in ... To date, no comprehensive evidence has indicated the method that yields the most effective outcomes in terms of alleviating urinary incontinence ...

4. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-01979-1

Meta-analysis of the therapeutic effect of electrical stimulation ... Meta-analysis results showed that electrical stimulation combined with pelvic floor muscle exercise could effectively mitigate the severity of female PFD.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715914600167

A Novel Externally Applied Neuromuscular Stimulator for ... Neuromuscular electrical stimulation (NMES) is commonly used to treat lower urinary tract dysfunctions. This study evaluated the efficacy of a novel externally ...

6. thepogp.co.uk thepogp.co.uk/_userfiles/pages/files/journals/124/gps89122ms.pdf

Safety and best practice in neuromuscular electrical ... A recent systematic review recommended that electrical stimulation with surface electrodes. (e.g. to the skin, vagina and anus) should not be offered as the ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/13685538.2025.2562662

Efficacy and safety of electrical stimulation and pelvic floor ... This study aimed to assess the efficacy and safety of early pelvic floor rehabilitation bioelectrical stimulation (BES) in postpartum stress urinary ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6486295/

Electrical stimulation with non‐implanted devices for stress ... We have evaluated an alternative treatment, electrical stimulation (ES) with non‐implanted devices, which aims to improve pelvic floor muscle function to ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04752709?term=AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Elidah,%20Inc.%22))&rank=2

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.

10. isrctn.com isrctn.com/ISRCTN68358784?q=&filters=conditionCategory:Urological%20and%20Genital%20Diseases&sort=&offset=233&totalResults=652&page=3&pageSize=100&searchType=basic-search

Safety and performance of Neuromuscular Electrical ... Safety and performance of Neuromuscular Electrical Stimulation (NMES) with the Neurotech Vital device for the treatment of stress urinary incontinence (SUI).