Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
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|ClinicalTrials.gov Identifier: NCT02981459|
Recruitment Status : Withdrawn (Withdrawn by Sponsor)
First Posted : December 5, 2016
Last Update Posted : July 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Urinary Frequency/Urgency Bladder Irritable Bladder Pain Syndrome||Drug: Mirabegron||Phase 4|
Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.
- To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.
- To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.
- To measure the number of patients with a 50% or greater reduction in bladder pain as measured in the O'Leary-Sant (OLS) IC symptom and problem, and the Lowell Parsons Pelvic Pain and Urgency/Frequency (PUF) patient symptom scale.
Intervention/Project goal: Treatment with Mirabegron 25mg for 4 weeks with an option for dose escalation to 50mg. Duration of study 12 weeks.
Inclusion criteria: Women between the ages of 18 and 89 with complaints of pain related urinary frequency are eligible to participate in the study.
Patients will be excluded from the study if they have:
- Severe Liver disease, Child-Pugh class c
- Severe Kidney disease, GFR<30
- Elevated blood pressure > 160/95 (in package insert bp >180/110)
- Urinary retention
- Pregnant, will become pregnant, or are nursing
- History of recurrent urinary tract infection
- Tachycardia: pulse > 100
- Presently on study drug mirabegron; patient must be willing to participate in a 30 day washout period to be eligible for inclusion
- Medications - metoprolol, desipramine, digoxin, propafenone, thioridazine, flecainide, warfarin
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation|
|Actual Study Start Date :||December 8, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
|Experimental: Mirabegron 25 mg or 50 mg||
daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
Other Name: Myrbetriq
- The number of pain motivated voids per 24 hours. [ Time Frame: 12 weeks ]
- The mean change from baseline to end of study in the daily average number of voids [ Time Frame: 12 weeks ]
- The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ) [ Time Frame: 12 weeks ]
- The mean change in the Patient Perception of Bladder Condition (PPBC) [ Time Frame: 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981459
|United States, New York|
|UBMD Obstetrics and Gynecology|
|Buffalo, New York, United States, 14222|
|Principal Investigator:||Tova S Ablove, MD||University at Buffalo|
|Study Chair:||Vanessa Barnabei, MD PHD||University at Buffalo|