Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
Study Details
Study Description
Brief Summary
The objective of this exploratory pilot study is to assess whether Mirabegron (Myrbetriq™) will improve the quality of sleep and Lower Urinary Tract Symptoms (LUTS) in men and women presenting with LUTS and disordered sleep.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with symptomatic LUTS and disordered sleep Patients exhibiting symptoms of LUTS and disordered sleep and who meet all inclusion/exclusion criteria will be prescribed Mirabegron for 12 weeks. |
Drug: Mirabegron
25 mg PO per day for four weeks. if tolerated then uptitrated to 50 mg PO per day for the remaining 8 weeks
Other Names:
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Outcome Measures
Primary Outcome Measures
- • Improvement from baseline on the PROMIS Sleep Disturbance scale at the 12 week follow-up. [12 weeks]
- • Improvement from baseline in the number micturitions/24 hours at the 12 week follow-up. [12 weeks]
Secondary Outcome Measures
- • Improvement from baseline on the Jenkins sleep scale at the 12 week follow-up. [12 weeks]
- • Improvement of nocturia (nocturnal voiding) based on the amount of voids that disrupt patient sleep in the voiding diary. [12 weeks]
Other Outcome Measures
- • Improvement from baseline on the International Prostate Symptom Score (IPSS)/American Urological Society Symptom Index (AUA-SI) scale at the 12 week follow-up. [at 12 week follow-up]
exploratory endpoint
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18.
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Subject is willing and able to complete the micturition diary and sleep questionnaires correctly.
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Symptoms of overactive bladder (OAB) (urinary frequency and urgency with or without urgency incontinence) for at least 3 months, with an IPSS ≥ 12.
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Moderate sleep disturbance with a mean score on the Jenkins Scale > 7.
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Micturitions/24 hrs ≥ 8; total excretory volume of <3L.
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Washout period of 2 weeks for any drugs not listed in the exclusions.
Exclusion Criteria:
- Subject is using prohibited medications which cannot be stopped safely at the screening visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria:
(i) Phytotherapy for benign prostatic hypertrophy (BPH) or a 5-alpha reductase inhibitor within 3 months.
(ii) Alpha blocker within 2 weeks. (iii) Taken an oral alpha agonist, tricyclic antidepressants, and anticholinergic or cholinergic medication within 2 weeks of the first screening visit with the following exception: topical anticholinergic eye drops used for glaucoma or inhaled anti-cholinergic used for chronic obstructive pulmonary disease (COPD).
(iv) Taken an estrogen, androgen, or any drug producing androgen suppression, or anabolic steroids within 3 months.
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Post void residual volume > 350 mL.
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Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control.
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Subject has neurogenic bladder.
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Any prior invasive intervention for LUTS (including bladder paralytics such as botulin toxin)
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Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test).
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Subject has an indwelling catheter or practices intermittent self-catheterization.
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Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease, diabetic neuropathy or any neurological diseases known to affect bladder function.
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Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs.
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Two documented independent urinary tract infections of any type in the past year.
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Patient with a diagnosed sleep disorder (ie. Obstructive Sleep Apnea) undergoing evaluation and treatment requiring change in care within 30 days of screening visit.
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Subject has moderate to severe hepatic impairment [ALT (SGPT), AST (SGOT) or GGT value greater than 3 times the upper limit of normal in the clinical center lab; confirmed on a second measurement].
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Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine greater than 2.0 mg/dl).
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PSA (prostate specific antigen) level greater than 10 ng/ml at the first screening visit (if male).
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Subject has severe uncontrolled hypertensionas defined by a systolic pressure ≥180 mmHg and/or diastolic pressure ≥120 mmHg.
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Subject has a clinically significant abnormal ECG or has a known history of QT prolongation or currently taking medication known to prolong the QT interval.
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Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive ingredients.
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Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. Men with a history of prostate cancer regardless of curability are not eligible.
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Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives.
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Unable to follow protocol directions due to organic brain or psychiatric disease.
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History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SIUSOM - Division of Urology | Springfield | Illinois | United States | 62794-9665 |
Sponsors and Collaborators
- Southern Illinois University
- Astellas Scientific & Medical Affairs, Inc.
- Sisters of the Third Order of St. Francis
Investigators
- Principal Investigator: Kevin McVary, MD, Southern Illinois University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MYRB-14B03