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NCT Number: NCT06620419

Clinical Study of External Electrical Stimulation for Male Incontinence

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Urinary Incontinence Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Lower Urinary Tract Symptoms Male Urogenital Diseases Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Pathological Conditions, Signs and Symptoms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Elidah

Monroe, Connecticut, 06468, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

Perineal-applied electrical stimulation

Device

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

Other names: Elidah, Elitone, Edytone

Primary outcomes

  1. Reduction in Leakage by Pad weight

    Time frame: 6 weeks

    24-hr pad weight

Secondary outcomes

  1. Safety measured by no Adverse events

    Time frame: 6 weeks

    No adverse events

  2. Quality of Life Improvement

    Time frame: 6 weeks

    Incontinence I-QoL survey

  3. Quality of Life Improvement

    Time frame: 6 weeks

    Sexual Health SHIM survey

  4. Reduction in leakage

    Time frame: 6 weeks

    As measured by Pads per day

  5. Reduction in leakage at Night

    Time frame: 6 weeks

    As measured by Nocturia episode

  6. Reduction in leakage

    Time frame: 6 weeks

    As measured by daytime leaking episodes

Sponsors and collaborators

Lead sponsor

Elidah, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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