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 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT07187466
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of PD determined by a board-certified neurologist with specialty training in movement disorders
* An ICIQ-OAB Symptom Score of 7 or higher, which indicates clinically significant symptoms of OAB, defined as presence of urinary urgency with or without urgency incontinence usually with increased daytime frequency and nocturia in the absence of infection or other obvious pathology
Exclusion Criteria:
* Significant cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of \< 18 or a telephone-MoCA score \< 13, which is the recommended diagnostic cut point for dementia in PD.
* Previous intensive pelvic floor muscle exercise training
* Clinically significant depression as measured by a Geriatric Depression Scale-Short Form score of 10 or higher which could affect motivation to fully engage in the intervention
* Use of an indwelling urinary catheter
* Post-void residual urine measurement by bladder ultrasound of \> 150 mL
* Severe uterine prolapse past the vaginal introitus
* Poorly controlled diabetes defined by a hemoglobin A1c (HgbA1c) of \>9.0% within the last 3 months. Participants with poorly controlled diabetes will be offered enrollment if the OAB symptoms persist after improvement in diabetes control
* Chronic renal failure and on hemodialysis
* Genitourinary cancer with ongoing surgical or external beam radiation treatment
* Previous artificial urinary sphincter, sling procedure or implanted sacral neuromodulation device
* History of bladder-injection of botulinum toxin in the last 12 months
* Any unstable health condition expected to result in hospitalization or death within in the next 3 months as determined by principal investigator.
* Hypersensitivity to drug class
* Contraindication to the study drug (mirabegron) including history of acute urinary retention requiring catheterization
* Current use of a bladder relaxant - permitted to enroll after one-week washout
* Hematuria on microscopic examination in the absence of infection. A urologic consultation will be recommended, and enrollment will depend on clearance by a urologist and agreement by the site PI that entry into the treatment protocol is not contraindicated
* If on diuretic, dose should be stable for at least 4 weeks
* If taking an alpha-blocker, dose should be stable for at least 4 weeks
* If taking dutasteride or finasteride, dose should be stable for at least 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07187466
Study Brief:
Protocol Section:
NCT07187466