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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT03846895
Eligibility Criteria:
Inclusion Criteria:
* Postmenopausal women (≥ 12 months of amenorrhea or FSH ≥ 40 after hysterectomy with bilateral oophorectomy) who receive β3 adrenergic receptors (mirabegron 50 mg) treatment for OAB
* Overactive bladder syndrome (OAB)
* ≥ 3 months symptoms of urgency, with or without urinary incontinence, and ≥ 8 micturitions / 24h
* At least 3 episodes of urgent urination (3rd-4th grade) as recorded in the patient perception intensity of urgency scale (PPiUS) during a 3 day urination calendar , with or without urinary incontinence.
Exclusion Criteria:
* Participants with:
* Pelvic Organ Prolapse (POP) \> stage II of the pelvic organ prolapse quantitation system (POP-Q)
* Post void residual volume \> 200 ml (measured by ultrasound)
* Use of moisturizers or lubricants the last month
* Use of vaginal estrogen in the last 6 months
* Use of drugs for urinary incontinence
* Use of psychotropic drugs
* Symptomatic urinary tract infection
* Active genital infection
* Kidney or liver disease
* Abnormal cardiac conduction, rate or rythm disorders
* Diabetic neuropathy
* Myasthenia gravis
* History of malignant disease
* Previous radio-chemo therapy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03846895
Study Brief:
Protocol Section:
NCT03846895