Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called Elidah that uses electrical stimulation to help men who have urinary incontinence after treatment for prostate cancer. Many men experience problems with leaking urine after their cancer treatment, and this study aims to see if the Elidah device can reduce these issues. To participate, men need to be at least 18 years old, have had moderate urinary incontinence for at least six months, and be able to read and write in English. They will also need to have specific types of urinary incontinence, like urge or stress incontinence.

Participants in the study will use the Elidah device at home for 20 minutes each day, five days a week, over six weeks. They will keep a daily log of their experiences and attend clinic visits to track their progress. During the study, they will also collect information about their urinary incontinence by using pads for a weight test. This trial is currently recruiting men who meet the eligibility criteria, and it could offer a potential new treatment option for those struggling with urinary issues after prostate cancer treatment.

Gender

MALE

Eligibility criteria

• * INCLUSION CRITERIA:
• • Participants must be male.
• • Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment.
• * Participants must have at least one of the following types of urinary incontinence:
• • stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing
• • urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer.
• • Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening.
• • Participants must be able to read and write in English.
• • Age \>= 18 years.
• • Eastern Cooperative Oncology Group (ECOG) performance status \<= 2.
• • Ability to understand and the willingness to sign a written informed consent document.
• EXCLUSION CRITERIA:
• • Change of therapy for prostate cancer planned during the study intervention.
• • History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence.
• • Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (\>= 4 UTIs within the 12 months prior to the study treatment initiation).
• • History of complete denervation of the pelvic floor.
• • Severe obesity (body mass index \[BMI\] \>35).
• • Pelvic pain/painful bladder syndrome.
• • Metal implant in the abdominal or pelvic area.
• • History of chronic cough with ongoing symptoms
• • An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems.
• • History of epilepsy.
• • History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence.
• • Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation.
• • Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.