Mirabegron and Urinary Urgency Incontinence
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|ClinicalTrials.gov Identifier: NCT02495389|
Recruitment Status : Recruiting
First Posted : July 13, 2015
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder||Drug: mirabegron||Phase 4|
Mirabegron is an FDA-approved medication for urgency incontinence. Evaluation of mirabegron's influence on clinical symptoms should take into account the effect of the female urinary microbiome (FUM) on patient response to treatment. Several bacterial species are more common in overactive bladder patients than in asymptomatic controls.
Currently, physicians have limited ability to personalize urinary urgency incontinence treatment, and thus the prescribed medication may provide minimal symptom relief for some patients. Since the FUM can be assessed prior to treatment, this study proposes to determine if baseline FUM assessment can provide insight into future symptoms relief with mirabegron treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mirabegron and Urinary Urgency Incontinence: The Clinical Response and the Female Urinary Microbiome|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
All study participants will receive 25 mg mirabegron (Myrbetriq) to be taken by mouth once a day for 12 weeks. If after 4 weeks symptoms are not adequately improving, participants will have the option of increasing mirabegron dose to 50 mg per day for the remaining 8 weeks.
All study participants will be given mirabegron, 25 mg by mouth once a day for 12 weeks.
Other Name: Myrbetriq
- Patient Perception of Bladder Control (PPBC) [ Time Frame: 12 weeks ]Self-report measure in which patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 (no problems at all) to 6 (many severe problems)
- Overactive Bladder Questionnaire (OAB-q) [ Time Frame: 12 weeks ]Self-report measure in which patients are asked to rate how much they have been bothered by bladder symptoms on a scale of 1 (not at all) to 6 (a very great deal). Patients are also asked to rate how much symptoms have affected their life on a scale of 1 (none of the time) to 6 (all of the time).
- Urinary Distress Inventory (UDI-6) [ Time Frame: 12 weeks ]Self-report measure in which patients are asked to rate how much they are bothered by symptoms of urinary urgency on a scale from 1(not at all) to 4 (quite a bit)
- Pelvic Floor Distress Inventory (PFDI) [ Time Frame: 12 weeks ]Self-report measure in which patients are asked to rate how much they are bothered by pelvic area symptoms on a scale from 1 (not at all) to 4 (quite a bit).
- Patient Global Impression of Severity (PGI-S) [ Time Frame: 12 weeks ]Self-report measure in which patients are asked to rate their urinary tract condition on a scale from 1 (normal) to 4 (severe).
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): NCT02495389
|Contact: Alan Wolfe, PhDemail@example.com|
|United States, Illinois|
|Loyola University Medical Center||Recruiting|
|Maywood, Illinois, United States, 60153|
|Contact: Alan Wolfe, PhD 708-216-5814 firstname.lastname@example.org|
|Principal Investigator:||Alan Wolfe, PhD||Loyola Univerity Medical Center|