NCT02410135已完成不适用
Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- • Improvement from baseline in the number micturitions/24 hours at the 12 week follow-up.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is willing and able to complete the micturition diary and sleep questionnaires correctly.
- •Symptoms of overactive bladder (OAB) (urinary frequency and urgency with or without urgency incontinence) for at least 3 months, with an IPSS ≥
- •Moderate sleep disturbance with a mean score on the Jenkins Scale >
- •Micturitions/24 hrs ≥ 8; total excretory volume of <3L.
- •Washout period of 2 weeks for any drugs not listed in the exclusions.
排除标准
- •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.
- •Post void residual volume > 350 mL.
- •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.
- •Subject has neurogenic bladder.
- •Any prior invasive intervention for LUTS (including bladder paralytics such as botulin toxin)
- •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).
- •Subject has an indwelling catheter or practices intermittent self-catheterization.
- •Known primary neurologic conditions such as multiple sclerosis, Parkinson's disease, diabetic neuropathy or any neurological diseases known to affect bladder function.
- •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.
- •Two documented independent urinary tract infections of any type in the past year.
- •Patient with a diagnosed sleep disorder (ie. Obstructive Sleep Apnea) undergoing evaluation and treatment requiring change in care within 30 days of screening visit.
- •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].
- •Subject has severe renal impairment or End Stage Renal disease (i.e., creatinine greater than 2.0 mg/dl).
- •PSA (prostate specific antigen) level greater than 10 ng/ml at the first screening visit (if male).
- •Subject has severe uncontrolled hypertensionas defined by a systolic pressure ≥180 mmHg and/or diastolic pressure ≥120 mmHg.
- •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.
- •Subject has a known or suspected hypersensitivity to Mirabegron or any of the inactive ingredients.
- •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.
- •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.
- •Unable to follow protocol directions due to organic brain or psychiatric disease.
- •History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
研究组 & 干预措施
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.
干预措施: Mirabegron (Drug)
结局指标
主要结局
• Improvement from baseline in the number micturitions/24 hours at the 12 week follow-up.
时间窗: 12 weeks
• Improvement from baseline on the PROMIS Sleep Disturbance scale at the 12 week follow-up.
时间窗: 12 weeks
次要结局
- • 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)
研究者
研究点 (1)
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