Clinical Study of External Electrical Stimulation for Male Incontinence

Description

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

Conditions

Urinary Incontinence

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Study Overview

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Study Details

Study overview

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

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

Clinical Study of External Electrical Stimulation for Male Incontinence

Condition
Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Monroe

Elidah, Monroe, Connecticut, United States, 06468

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Elidah, Inc.,

Gloria Kolb, MS,MBA, PRINCIPAL_INVESTIGATOR, Elidah, Inc.

Study Record Dates

2025-02