Have you or your loved ones been diagnosed with overactive bladder?

You may be eligible to participate in a overactive bladder clinical trial.

Have you or your loved ones been diagnosed with overactive bladder? You may be eligible to participate in a overactive bladder clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Overactive Bladder Clinical Trial in Maywood IL

NCT02495389 | Phase 4 | Interventional

Have you or your loved ones been diagnosed with overactive bladder?

You may be eligible to participate in a overactive bladder clinical trial.

Have you or your loved ones been diagnosed with overactive bladder? You may be eligible to participate in a overactive bladder clinical trial.

Completed

Female

18 Years +

This study has recruited 84 Participants

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.

Show me more details

Details for the study

Brief Title

Mirabegron and Urinary Urgency Incontinence

Official Title

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

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.

Treatments and/or Procedures

Mirabegron

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

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.

12 weeks

Secondary

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.

12 weeks

Secondary

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.

12 weeks

Secondary

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.

12 weeks

Secondary

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.

12 weeks

Study 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