Overactive Bladder SyndromePhase 4NCT03695822
Impact of Beta-3 Agonist on Psychological Distress and Blood Flow of the Bladder in Women With Overactive Bladder Syndrome
A Phase 4 study testing Mirabegron 25mg in people with Overactive Bladder Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- Mirabegron 25mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Dec 2018to 31 Jan 2019
- Phase
- Phase 4
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All OAB female patients
- >20 years
Who cannot join
- Allergy to mirabegron, urinary tract infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Far Eastern Memorial Hospital
We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.
Read the detailed description
Background/Purpose: Pharmacologic treatments for female overactive bladder syndrome (OAB) include antimuscarinics and beta-agonist. Similar efficacy has been reported between antimuscarinics and beta-agonist. Antimuscarinics has been found to be beneficial for patients with psychological distress. However, the impact of mirabegron on psychological distress in female OAB remains unknown. In addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. Besides, c reactive protein was found to be elevated in female OAB. Nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. Thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Mirabegron 25mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 25mgDrug
The aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
| Study group | Role | What they receive |
|---|---|---|
| Mirabegron | Experimental | OAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment Receives: Drug: Mirabegron 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief symptom rating scale
The Brief symptom rating scale (BSRS) includes the following dimensions of psychopathology: somatic symptoms, obsessive-compulsive symptoms, interpersonal sensitivity, depressive symptoms, anxiety symptoms, hostility, phobic-anxiety, and paranoid tendency. Additional symptoms include vegetative and other clinical indicators. The BSRS is composed of 30 items rated on the basis of degree of distress caused by that item over the past week. Each dimension is assessed by several questions with a 5-point Likert scale (0-4 points). The severity of a psychopathologic factor is expressed with an index calculated from the sum of scores divided by the number of questions in that specific dimension. The General Symptom Index (GSI), a mean score of all BSRS items, represents the global severity of psychological distress (PD), and a higher GSI indicates more severe PD. The BSRS has been reported to be a reliable and valid psychiatric self-rating scale for use in psychosomatic research.
Measured: 12 weeks
Secondary outcomes (1)
Bladder wall blood flow
vascularization index (VI) 、flow index (FI) and vascularization flow index (VFI)
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start24 Dec 2018
- Primary completion21 Jan 2019
- Study completion31 Jan 2019
Why it stopped: I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng-Mou Hsiao, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695822
- Sponsor's protocol ID
- 107009-F
- Status last verified
- May 2018
- First submitted
- 1 Oct 2018
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT03695822
- Acronym / sponsor ID
- 107009-F
- Conditions
- Overactive Bladder Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: I did not pass the 2018 Ministry of Science and Technology research project subsidy, so I applied for the project to close the case.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 4 Oct 2018 (actual)
- 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.
We will get the impact of mirabegron on psychological distress, urethra and bladder blood flow and c reactive protein.
Detailed description
Background/Purpose: Pharmacologic treatments for female overactive bladder syndrome (OAB) include antimuscarinics and beta-agonist. Similar efficacy has been reported between antimuscarinics and beta-agonist. Antimuscarinics has been found to be beneficial for patients with psychological distress. However, the impact of mirabegron on psychological distress in female OAB remains unknown. In addition, some animal studies found that beta-3 agonist can improve arterial blood flow, bladder ischemia and might improve bladder function; however, there is still lack of human study. Besides, c reactive protein was found to be elevated in female OAB. Nonetheless there is no study mentioning about the impact of mirabegron on c reactive protein. Thus, the aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirabegron | Experimental | Drug: Mirabegron 25mgOAB female patients who will receive beta-3 agonist (mirabegron 2 mg) treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All OAB female patients
- >20 years
Key exclusion criteria (1 listed)
- Allergy to mirabegron, urinary tract infections
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 |
|---|---|---|
| Mirabegron 25mgThe aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein. | Drug | Mirabegron |
Primary outcome
Brief symptom rating scale
Time frame: 12 weeks
The Brief symptom rating scale (BSRS) includes the following dimensions of psychopathology: somatic symptoms, obsessive-compulsive symptoms, interpersonal sensitivity, depressive symptoms, anxiety symptoms, hostility, phobic-anxiety, and paranoid tendency. Additional symptoms include vegetative and other clinical indicators. The BSRS is composed of 30 items rated on the basis of degree of distress caused by that item over the past week. Each dimension is assessed by several questions with a 5-point Likert scale (0-4 points). The severity of a psychopathologic factor is expressed with an index calculated from the sum of scores divided by the number of questions in that specific dimension. The General Symptom Index (GSI), a mean score of all BSRS items, represents the global severity of psychological distress (PD), and a higher GSI indicates more severe PD. The BSRS has been reported to be a reliable and valid psychiatric self-rating scale for use in psychosomatic research.
1 secondary outcome
Bladder wall blood flow
Time frame: 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirabegron 25mg in people with Overactive Bladder Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 7 Mar 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 Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Brief symptom rating scale (time frame: 12 weeks). 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 7 Mar 2019.