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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07366918
Eligibility Criteria:
Inclusion Criteria:
* Women over the age of 18 with a clinical diagnosis of idiopathic OAB
* Intolerant or unresponsive to antimuscarinic or oral β3 adrenoceptor agonist (mirabegron) medications and not using them for at least 4 weeks
* Ability to understand the procedures, advantages, and potential side effects
* Ability to provide written, informed consent
* Pelvic floor muscle (PFM) strength of 3/5 or higher (modified Oxford scale, minimum: 0 - maximum: 5)
Exclusion Criteria:
* Women with pure stress urinary incontinence
* History of conservative treatment for OAB within the last 6 months (MI, IVES, perineal ES, etc.)
* Pregnant or planning to become pregnant at the time of the study
* Diagnosis of vaginal infection, urinary tract infection, or cancer
* Women with urinary incontinence within the last 3 months Those who have undergone urogynecological surgery
* Those with genital area disorders that may preclude the use of a vaginal probe or perineal electrode
* Those diagnosed with stage 2 or higher according to the Pelvic Organ Prolapse Assessment (POP-Q)
* Those with a pacemaker or implanted defibrillator
* Those with neurogenic bladder or a history of neurological disease
* Those with a urine residual of more than 100 ml detected by ultrasound (using an ultrasound device)
* Those with allergies to condoms or lubricating gels used with a vaginal probe or perineometer
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07366918
Study Brief:
Protocol Section:
NCT07366918