Clinical Trial: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation
Brief Summary: The specific purpose of this study is to provide objective data in prospective open label design (n=40) to support the use of Mirabegron as a treatment for pain related urinary frequency and urgency. Women with bladder pain have a poor response to traditional anticholinergic therapy for their symptoms of frequency and urgency.
Detailed Summary:
Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.
Specific Aims:
- 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.
Exclusion criteria:
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
- Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: State University of New York at Buffalo
Dates:
Date Received: December 1, 2016
Date Started: January 2017
Date Completion: April 2019
Last Updated: December 2, 2016
Last Verified: November 2016