Overactive Bladder SyndromeNCT05040984
Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome
An observational study of Overactive Bladder Syndrome, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed. 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?
- Solifenacin Oral Tablet and Mirabegron 25mg
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2021to 31 Dec 2024
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment.
Who may be able to join
- Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment
Who cannot join
- <20 year-old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
Banqiao District, New Taipei, 22050
Sheng-Mou Hsiao, M.D., +886-2-89667000 ext. 1818, smhsiao2@gmail.com
About this study
A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- Solifenacin Oral Tablet, Mirabegron 25mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin Oral TabletDrug
Solifenacin 1 tablet per day
Mirabegron 25mgDrug
Mirabegron 1 tablet per day
| Study group | Role | What they receive |
|---|---|---|
| solifenacin | Not described Receives: Drug: Solifenacin Oral Tablet | |
| mirabegron | Not described Receives: Drug: Mirabegron 25mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of persistence of mirabegron versus solifenacin use
Measured: 13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start30 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
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
- NCT05040984
- Sponsor's protocol ID
- 110053-E
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT05040984
- Acronym / sponsor ID
- 110053-E
- Conditions
- Overactive Bladder Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Sep 2021 (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.
A retrospective analysis of medical records at Far Eastern Memorial Hospital from January 2008 to May 2020 about female patients with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment. Factors affecting persistence of OAB medications will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solifenacin | – | Drug: Solifenacin Oral Tablet |
| mirabegron | – | Drug: Mirabegron 25mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with overactive bladder syndrome, who received Solifenacin or Mirabegron as the initial treatment.
Key inclusion criteria (1 listed)
- Women with overactive bladder syndrome received solifenacin or mirabegron as the initial treatment
Key exclusion criteria (1 listed)
- <20 year-old
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 |
|---|---|---|
| Solifenacin Oral TabletSolifenacin 1 tablet per day | Drug | solifenacin |
| Mirabegron 25mgMirabegron 1 tablet per day | Drug | mirabegron |
Primary outcome
Predictors of persistence of mirabegron versus solifenacin use
Time frame: 13 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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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.
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 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 1 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: status not confirmed, as of the sponsor's last update on 29 Mar 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Mou Hsiao, MD (+886919302632, smhsiao2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of persistence of mirabegron versus solifenacin use (time frame: 13 years). 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 29 Mar 2023.