Clinical Study of External Electrical Stimulation for Male Incontinence
Launched by ELIDAH, INC. · Sep 27, 2024
Trial Information
Current as of November 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment called Elidah neuromuscular stimulation to help reduce urinary incontinence in men who have had prostate surgery. Urinary incontinence is when a person has trouble controlling their bladder, which can lead to leakage. The trial is currently recruiting participants, specifically men aged 65 to 74 who are scheduled for robotic-assisted prostate surgery and experience mild incontinence, using at least one pad per day.
To join the study, participants must be able to read and speak English and meet certain health criteria. They should not have a history of specific types of incontinence or certain medical conditions, such as severe obesity or heart problems. Participants can expect to receive the neuromuscular stimulation treatment and be monitored for its effectiveness. This study aims to provide helpful information on how well this treatment works for men dealing with incontinence after prostate surgery.
Gender
MALE
Eligibility criteria
- 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.
About Elidah, Inc.
Elidah, Inc. is a pioneering biotechnology company dedicated to advancing innovative solutions in the field of women's health. With a focus on developing cutting-edge medical devices and therapies, Elidah is committed to addressing unmet needs and improving patient outcomes. The company emphasizes rigorous clinical research and collaboration with healthcare professionals to ensure the efficacy and safety of its products. By leveraging state-of-the-art technology and a patient-centered approach, Elidah aims to enhance quality of life for women, driving progress in both clinical and consumer healthcare markets.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Monroe, Connecticut, United States
Patients applied
Trial Officials
Gloria Kolb, MS,MBA
Principal Investigator
Elidah, Inc.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported