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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT02981459
Eligibility Criteria:
Inclusion Criteria:
1. English-speaking women
2. Age: 18 and 89 years
3. Pain related urinary frequency or urgency associated with \>70% of voids. With a minimum of 7 pain motivated voids in 24 hours.
4. Bladder capacity: \> 300 ml
5. Urinary frequency: 10 or more voids in 24/hours on voiding diary
Exclusion Criteria:
1. Severe Liver disease: Child-Pugh class c
2. Severe Kidney disease: GFR\<30
3. Elevated blood pressure \> 160/95 (in package insert bp \>180/110)
4. Pregnant, will become pregnant, or are nursing during the study
5. History of recurrent urinary tract infection: 3 or more culture proven urinary tract infections in the past 12 months. An active urinary tract infection.
6. Tachycardia: pulse \> 100, or any other history of arrhythmia
7. Intense urge: bladder volumes of \<150 ml on cystometry
8. Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
9. Medications: metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
10. Pain medications: no dose changes in narcotic or non-steroidal medications while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
11. Neurogenic pain medications such as gabapentin or amitriptyline: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
12. Anticholinergic medications for incontinence: no dose changes while on study. Patient must be on a stable medication dose for at least 30 days prior to the screening visit.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
89 Years
Study:
NCT02981459
Study Brief:
Protocol Section:
NCT02981459