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

NCT02410135 | Completed

• 1 other identifier: MYRB-14B03
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Urinary Tract Symptoms; Nocturia

Keywords

Lower Urinary Tract Symptoms; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• • 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 Outcomes (2)

• • 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 Outcomes (1)

• • 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

Study Arms (1)

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

Interventions

Mirabegron DRUG

25 mg PO per day for four weeks. if tolerated then uptitrated to 50 mg PO per day for the remaining 8 weeks

Also known as: Myrbetriq

Patients with symptomatic LUTS and disordered sleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients with lower urinary tract symptoms and sleep disturbance

You may qualify if:

• Age ≥ 18.
• 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 ≥ 12.
• Moderate sleep disturbance with a mean score on the Jenkins Scale \> 7.
• Micturitions/24 hrs ≥ 8; total excretory volume of \<3L.

You may not qualify if:

• 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 \[ALT (SGPT), AST (SGOT) or GGT value greater than 3 times the upper limit of normal in the clinical center lab; confirmed on a second measurement\].

Sponsors & Collaborators

• Southern Illinois University: lead
• Astellas Scientific & Medical Affairs, Inc.: collaborator
• Sisters of the Third Order of St. Francis: collaborator

Study Sites (1)

SIUSOM - Division of Urology

Springfield, Illinois, 62794-9665, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Nocturia; Parasomnias

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kevin McVary, MD

  Southern Illinois University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2015
• First Posted: April 7, 2015
• Study Start: April 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 9, 2019

Record last verified: 2018-09

Locations

US (1)