Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
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.
Inclusion Criteria:

 1. Age ≥ 18.

 2. Subject is willing and able to complete the micturition diary and sleep questionnaires
 correctly.

 3. Symptoms of overactive bladder (OAB) (urinary frequency and urgency with or without
 urgency incontinence) for at least 3 months, with an IPSS ≥ 12.

 4. Moderate sleep disturbance with a mean score on the Jenkins Scale > 7.

 5. Micturitions/24 hrs ≥ 8; total excretory volume of <3L.

 6. Washout period of 2 weeks for any drugs not listed in the exclusions.

 Exclusion Criteria:

 1. 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.

 2. Post void residual volume > 350 mL.

 3. 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.

 4. Subject has neurogenic bladder.

 5. Any prior invasive intervention for LUTS (including bladder paralytics such as botulin
 toxin)

 6. 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).

 7. Subject has an indwelling catheter or practices intermittent self-catheterization.

 8. Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease,
 diabetic neuropathy or any neurological diseases known to affect bladder function.

 9. 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.

 10. Two documented independent urinary tract infections of any type in the past year.

 11. Patient with a diagnosed sleep disorder (ie. Obstructive Sleep Apnea) undergoing
 evaluation and treatment requiring change in care within 30 days of screening visit.

 12. 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].

 13. Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine
 greater than 2.0 mg/dl).

 14. PSA (prostate specific antigen) level greater than 10 ng/ml at the first screening
 visit (if male).

 15. Subject has severe uncontrolled hypertensionas defined by a systolic pressure ≥180
 mmHg and/or diastolic pressure ≥120 mmHg.

 16. 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.

 17. Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive
 ingredients.

 18. 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.

 19. 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.

 20. Unable to follow protocol directions due to organic brain or psychiatric disease.

 21. History of alcoholism or any other substance abuse, which, in the opinion of the
 investigator, would affect compliance with the protocol.