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Active, not recruitingNCT06620419Updated Jan 27, 2026

Clinical Study of External Electrical Stimulation for Male Incontinence

An interventional study of Perineal-applied electrical stimulation in Urinary Incontinence, sponsored by Elidah, Inc.. Active, not recruiting at 1 site in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-27.

Sponsored by Elidah, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
Male
01

Study summary

The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.

02

Conditions studied

  • Urinary Incontinence

Keywords

  • male
  • men
  • prostatetectomy
  • incontinence
  • electrical stimulation
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 30 is below the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Elidah, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Scheduled for robotic-assisted laparoscopic prostatectomy
  • Read and speak English
  • Predominant SUI of at least 1 pad/day

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Treatment group

    Self-applied electrical stimulation for 6 weeks.

    Device: Perineal-applied electrical stimulation

Interventions

  • DevicePerineal-applied electrical stimulation

    Small controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area.

    Also known as: Elidah, Elitone, Edytone

06

What researchers measure

Primary outcomes

  1. Reduction in Leakage by Pad weight

    24-hr pad weight

    Time frame: 6 weeks

Secondary outcomes

  1. Safety measured by no Adverse events

    No adverse events

    Time frame: 6 weeks

  2. Quality of Life Improvement

    Incontinence I-QoL survey

    Time frame: 6 weeks

  3. Quality of Life Improvement

    Sexual Health SHIM survey

    Time frame: 6 weeks

  4. Reduction in leakage

    As measured by Pads per day

    Time frame: 6 weeks

  5. Reduction in leakage at Night

    As measured by Nocturia episode

    Time frame: 6 weeks

  6. Reduction in leakage

    As measured by daytime leaking episodes

    Time frame: 6 weeks

07

Study locations

1 site
  • Elidah
    Monroe, Connecticut 06468, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06620419
Lead sponsor
Elidah, Inc.
Responsible party
Sponsor
First posted
Oct 1, 2024
Start date
May 15, 2024
Primary completion
Jun 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jan 27, 2026

Study contacts

Gloria Kolb, MS,MBA
principal investigator · Elidah, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Elidah, Inc.

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