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:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT05416450
Eligibility Criteria:
Inclusion Criteria:
* Over the age of 18 with the clinical diagnosis of idiopathic OAB
* Who could able to give written informed consent and understand the procedures
Exclusion Criteria:
* Women who had stress urinary incontinence
* A history of conservative therapy (BT, ES) for OAB within 6 months
* Urogynecological surgery within 3 months
* Current vulvovaginitis or urinary tract infections or malignancy
* Pregnancy
* Cardiac pacemaker or implanted defibrillator
* Anatomic structural disorders of the genital region that did not allow to apply the vaginal probe
* The strength of PFM less than 3/5 (graded as modified Oxford scale, min:0-max:5)
* The pelvic organ prolapse quantification (POP-Q) (stage 2 or more)
* Neurogenic bladder
* The peripheral or central neurologic pathology
* Ultrasonographic evidence of post-void residual urine volume more than 100 ml
* Allergy to condom or lubricant gel that is used with vaginal probe
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05416450
Study Brief:
Protocol Section:
NCT05416450