Lower Urinary Tract SymptomsNCT02410135
Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
An observational study of Lower Urinary Tract Symptoms and Nocturia, run by Southern Illinois University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Urinary Tract Symptoms, Nocturia
- What is being tested?
- Mirabegron
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients with lower urinary tract symptoms and sleep disturbance
Who may be able to join
- 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.
- Washout period of 2 weeks for any drugs not listed in the exclusions.
Who cannot join
- 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:
- Phytotherapy for benign prostatic hypertrophy (BPH) or a 5-alpha reductase inhibitor within 3 months.
- 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).
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
SIUSOM - Division of Urology
Springfield, Illinois, 62794-9665
About this study
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
- Being tested
- Mirabegron
- Keywords
- Lower Urinary Tract Symptoms, Sleep Disturbance
- Medical subject headings
- Lower Urinary Tract Symptoms, Nocturia, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirabegronDrug
Also called Myrbetriq
25 mg PO per day for four weeks. if tolerated then uptitrated to 50 mg PO per day for the remaining 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Improvement from baseline on the PROMIS Sleep Disturbance scale at the 12 week follow-up.
Measured: 12 weeks
• Improvement from baseline in the number micturitions/24 hours at the 12 week follow-up.
Measured: 12 weeks
Secondary outcomes (2)
• Improvement from baseline on the Jenkins sleep scale at the 12 week follow-up.
Measured: 12 weeks
• Improvement of nocturia (nocturnal voiding) based on the amount of voids that disrupt patient sleep in the voiding diary.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc., Sisters of the Third Order of St. Francis
- Responsible party
- Sponsor
- Investigators
- Kevin McVary, MD, Principal investigator, Southern Illinois University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410135
- Sponsor's protocol ID
- MYRB-14B03
- Status last verified
- Sep 2018
- First submitted
- 1 Apr 2015
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myrbetriq™ (Mirabegron) to Improve Disordered Sleep in Subjects With Lower Urinary Tract Symptoms (LUTS)
- ClinicalTrials.gov ID
- NCT02410135
- Acronym / sponsor ID
- MYRB-14B03
- Conditions
- Lower Urinary Tract Symptoms, Nocturia
- Keywords
- Lower Urinary Tract Symptoms, Sleep Disturbance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- Astellas Scientific & Medical Affairs, Inc., Sisters of the Third Order of St. Francis
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with symptomatic LUTS and disordered sleep | – | Drug: MirabegronPatients exhibiting symptoms of LUTS and disordered sleep and who meet all inclusion/exclusion criteria will be prescribed Mirabegron for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients with lower urinary tract symptoms and sleep disturbance
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirabegronAlso: Myrbetriq25 mg PO per day for four weeks. if tolerated then uptitrated to 50 mg PO per day for the remaining 8 weeks | Drug | Patients with symptomatic LUTS and disordered sleep |
Primary outcome
• Improvement from baseline on the PROMIS Sleep Disturbance scale at the 12 week follow-up.
Time frame: 12 weeks
• Improvement from baseline in the number micturitions/24 hours at the 12 week follow-up.
Time frame: 12 weeks
2 secondary outcomes
• Improvement from baseline on the Jenkins sleep scale at the 12 week follow-up.
Time frame: 12 weeks
• Improvement of nocturia (nocturnal voiding) based on the amount of voids that disrupt patient sleep in the voiding diary.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin McVary, MD principal investigator
Southern Illinois University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Urinary Tract Symptoms and Nocturia, run by Southern Illinois University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Improvement from baseline on the PROMIS Sleep Disturbance scale at the 12 week follow-up. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2019.