RECRUITING

Clinical Study of External Electrical Stimulation for Male Incontinence

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Conditions

Urinary Incontinencemalemenprostatetectomyincontinenceelectrical stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

Quick Facts

Study Start:2024-05-15
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06620419

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled for robotic-assisted laparoscopic prostatectomy
  2. * Read and speak English
  3. * Predominant SUI of at least 1 pad/day
  1. * History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
  2. * Complete denervation of the pelvic floor
  3. * Severe Obesity as defined by BMI \>= 40
  4. * Has undergone pre-op pelvic floor exercise strengthening
  5. * Pelvic pain/painful bladder syndrome
  6. * Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
  7. * History of epilepsy
  8. * Underlying neurologic/neuromuscular disorder
  9. * Metal implants in the abdomen or pelvic area
  10. * Chronic coughing
  11. * Impaired decision making, suicidal thoughts, or drug/alcohol dependence
  12. * Uncontrolled intercurrent illness that would limit compliance with study requirements
  13. * Lacks capacity to adhere with study requirements
  14. * Lacks capacity to consent for themselves.

Contacts and Locations

Study Contact

Gloria Kolb, MS MBA
CONTACT
978-435-4324
elidahstudy@gmail.com

Principal Investigator

Gloria Kolb, MS,MBA
PRINCIPAL_INVESTIGATOR
Elidah, Inc.

Study Locations (Sites)

Elidah
Monroe, Connecticut, 06468
United States

Collaborators and Investigators

Sponsor: Elidah, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-15
Study Completion Date2025-02

Study Record Updates

Study Start Date2024-05-15
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • male
  • men
  • prostatetectomy
  • incontinence
  • electrical stimulation

Additional Relevant MeSH Terms

  • Urinary Incontinence