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Mirabegron and Urinary Urgency Incontinence

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Mirabegron

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Urgency Incontinence, Mirabegron, Myrbetriq, Betmiga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant)
No contraindications to taking mirabegron
Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment

Exclusion Criteria:

Neurologic disease known to affect the lower urinary tract
Systemic immunologic deficiency
Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs
History or current pelvic malignancy or radiation
Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II
A contraindication to receiving mirabegron
Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception
Must not have taken any antibiotics in the 4 weeks prior to enrollment

Sites / Locations

Loyola University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mirabegron

Arm Description

Participants received mirabegron (Myrbetriq) daily for 12 weeks

Outcomes

Primary Outcome Measures

Response to Therapy

Response to therapy was measured using the Patient Perception of Bladder Control (PPBC) questionnaire which measures patients' perceived bladder condition on a 6-point ordinal scale ranging from 1 (no problems at all) to 6 (many severe problems). Women reporting a PPBC score of 4 or 5 by week 12 responded to therapy. Women reporting a PPBC score of 1, 2, or 3 by week 12 did not respond to therapy.

Secondary Outcome Measures

Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)

The Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL) score is a measure of patients' bladder symptom severity. It ranges from 25 to 150 where higher scores indicate greater quality of life.

Change in Urinary Distress Inventory (UDI)

The Urinary Distress Inventory is a 29-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.

Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score

The Pelvic Organ Prolapse Distress Inventory (POPDI) is a 16-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 300 where higher scores indicate worsening symptom severity.

Change in Colo-Rectal-Anal Distress Inventory (CRADI)

The Colo-Rectal-Anal Distress Inventory (CRADI) is a 17-item questionnaire that asks patients to report how bothered they are by symptoms of urinary urgency on a scale from 1 (not at all) to 4 (quite a bit). The total score ranges from 0 to 400 where higher scores indicate worsening symptom severity.

Full Information

NCT ID

NCT02495389

First Posted

July 9, 2015

Last Updated

October 30, 2020

Sponsor

Loyola University

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02495389

Brief Title

Mirabegron and Urinary Urgency Incontinence

Official Title

Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 28, 2015 (Actual)

Primary Completion Date

January 29, 2019 (Actual)

Study Completion Date

January 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Loyola University

Collaborators

Astellas Pharma US, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study is for women diagnosed with urinary urgency incontinence (UUI) or overactive bladder (OAB). Some patients continue to have symptoms even while taking medication for OAB. The purpose of this study is to estimate the number of women who respond to a medication called mirabegron and estimate change in symptom severity over 12 weeks of therapy. A secondary goal is to correlate the female urinary microbiome (FUM) with response to treatment and change in symptom severity over 12 weeks of therapy.

Detailed Description

Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's influence on clinical symptoms may need to take into account the effect of the female urinary microbiome (FUM) on a patient's response to treatment. Compared to asymptomatic patients, several bacterial species are more common in patients with overactive bladder. Currently, physicians have limited ability to personalize a patient's urinary urgency incontinence treatment and, consequently, the prescribed medication may provide minimal symptom relief. Since the FUM can be assessed prior to treatment, this study proposes to determine if baseline FUM assessment can provide insight into future symptom relief with mirabegron treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Urinary Urgency Incontinence, Mirabegron, Myrbetriq, Betmiga

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

All patients receive mirabegron daily for 12 weeks

Masking

None (Open Label)

Masking Description

There is no masking scheme

Allocation

N/A

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mirabegron

Arm Type

Experimental

Arm Description

Participants received mirabegron (Myrbetriq) daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Mirabegron

Other Intervention Name(s)

Myrbetriq, Betmiga

Intervention Description

Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.

Primary Outcome Measure Information:

Title

Response to Therapy

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in Overactive Bladder Questionnaire (OAB-q) Health Related Quality of Life (HRQL)

Description

Time Frame

12 weeks

Title

Change in Urinary Distress Inventory (UDI)

Description

Time Frame

12 weeks

Title

Change in Pelvic Organ Prolapse Distress Inventory (POPDI) Score

Description

Time Frame

12 weeks

Title

Change in Colo-Rectal-Anal Distress Inventory (CRADI)

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Bothersome idiopathic (non-neurologic) urgency urinary incontinence (UUI) who recall ≥ 5 urgency predominant urinary incontinence episodes in the prior week (urgency urinary incontinence or mixed urinary incontinence-urgency predominant) No contraindications to taking mirabegron Patients on current OAB therapy will undergo a two-week drug washout period prior to baseline assessment Exclusion Criteria: Neurologic disease known to affect the lower urinary tract Systemic immunologic deficiency Current urinary tract infection (UTI) (based on dipstick assessment) or recurrent culture-proven UTIs History or current pelvic malignancy or radiation Untreated symptomatic pelvic organ prolapse (POP) > POP-Q Stage II A contraindication to receiving mirabegron Women of childbearing potential who are pregnant or nursing or intend to become pregnant during the study, or who are not practicing a reliable method of contraception Must not have taken any antibiotics in the 4 weeks prior to enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Wolfe, PhD

Organizational Affiliation

Loyola Univerity Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

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Mirabegron and Urinary Urgency Incontinence

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