Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

Phase 4

Withdrawn

• Conditions: Bladder Irritable; Bladder Pain Syndrome; Urinary Frequency/Urgency
• Interventions: Drug: Mirabegron

• Registration Number: NCT02981459
• Lead Sponsor: State University of New York at Buffalo

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 Description

Hypothesis: Mirabegron is effective in reducing symptoms in women with pain related urinary frequency and urgency.

Specific Aims:

1. To measure the efficacy of Mirabegron in the treatment of frequency and urgency, using voiding diaries.

2. To measure the number of patients with a 50% or greater reduction in frequency and urgency, using voiding diaries.

3. 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:

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. Urinary retention

5. Pregnant, will become pregnant, or are nursing

6. History of recurrent urinary tract infection

7. Tachycardia: pulse \> 100

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

Study Timeline

• Study First Submitted: 2016-12-01
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-05
• Study Start: 2017-12-08
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirabegron 25 mg or 50 mg	Mirabegron	-

Primary Outcome Measures

Name	Time	Method
The number of pain motivated voids per 24 hours.	12 weeks

Secondary Outcome Measures

Name	Time	Method
The Mean change in global urinary symptoms based upon scores from the Urgency Severity and Impact Questionnaire (USIQ)	12 weeks
The mean change in the Patient Perception of Bladder Condition (PPBC)	12 weeks
The mean change from baseline to end of study in the daily average number of voids	12 weeks

Trial Locations

Locations (1)

UBMD Obstetrics and Gynecology; 🇺🇸 Buffalo, New York, United States