Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT06161506
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT06161506
Study Brief:
Protocol Section:
NCT06161506