Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-28 @ 11:26 AM
Study NCT ID:
NCT02981459
Status:
WITHDRAWN
Last Update Posted:
2020-10-22
First Post:
2016-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women
Sponsor:
State University of New York at Buffalo
Organization:
Study Overview
Official Title:
Pilot Study: Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women, an Open Label Study With Dose Escalation
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: