Urinary Bladder, OveractivePhase 3NCT07114640
The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial
A Phase 3 study testing Mirabegron 25mg, Solifenacin 5 mg and Tolterodine 4 mg in people with Urinary Bladder, Overactive, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Mirabegron 25mg, Solifenacin 5 mg and Tolterodine 4 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Aug 2025to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old.
- female patients with overactive bladder syndrome
Who cannot join
- Clinically significant dysuria (inability to urinate, difficulty urinating).
- Severe stress urinary incontinence (urinary incontinence caused by coughing).
- Mixed urinary incontinence mainly caused by stress urinary incontinence (urinary incontinence caused by coughing as the main symptom).
- Contraindications to antimuscarinic drugs or adrenergic receptor agonists.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
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
Official title: Far Eastern Memorial Hospital
The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions:
Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?
Read the detailed description
We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks.
The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Mirabegron 25mg, Solifenacin 5 mg, Tolterodine 4 mg, Oxybutynin ER 5 mg
- Keywords
- autonomic nerve system, nocturia, psychologic distress, sexual function, bladder blood perfusion, heart rate variability, overactive bladder syndrome
- Medical subject headings
- Urinary Bladder, Overactive, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirabegron 25mgDrug
Taking 25 mg mirabegron in the nighttime
Solifenacin 5 mgDrug
Taking 5 mg solifenacin in the nighttime
Tolterodine 4 mgDrug
Taking 5 mg tolterodine in the nighttime
Oxybutynin ER 5 mgDrug
Taking 5 mg oxybutynin ER in the nighttime
| Study group | Role | What they receive |
|---|---|---|
| mirabegron | Active comparator | mirabegron 25 mg Receives: Drug: Mirabegron 25mg |
| Solifenacin | Active comparator | Solifenacin 5mg Receives: Drug: Solifenacin 5 mg |
| Tolterodine | Active comparator | Tolterodine 4mg Receives: Drug: Tolterodine 4 mg |
| Oxybutynin ER | Active comparator | Oxybutynin ER 5mg Receives: Drug: Oxybutynin ER 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of overactive bladder symptoms
Comparisons of the changes of overactive bladder symptom score between groups
Measured: 12 weeks
Secondary outcomes (2)
Change of heart rate variability
Comparisons of the changes of heart rate variability between groups
Measured: 12 weeks
Change of bladder blood perfusion
Comparisons of the changes of bladder blood perfusion between groups
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 posted11 Aug 2025
- Study start7 Aug 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT07114640
- Sponsor's protocol ID
- 110416-F
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Far Eastern Memorial Hospital
- ClinicalTrials.gov ID
- NCT07114640
- Acronym / sponsor ID
- 110416-F
- Conditions
- Urinary Bladder, Overactive
- Keywords
- autonomic nerve system, nocturia, psychologic distress, sexual function, bladder blood perfusion, heart rate variability, overactive bladder syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 7 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Aug 2025 (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.
The optimal medication for women with nocturia remains uncertain. This clinical trial aimed to determine the most effective medication for women with overactive bladder and nocturia. Its primary objectives were to answer the following questions:
Which medication is most effective for women with nocturia? Which medication has the least effect on heart rate variability in women with nocturia?
Detailed description
We will conduct a prospective randomized controlled study in the outpatient clinic of Department of Obstetrics and Gynecology of Far Eastern Memorial Hospital. All female patients with overactive bladder syndrome enrolled in the study will be requested to fill in the questionnaires and before taking the drug and four weeks and twelve weeks after taking the medication. In addition, measurement of heart rate variability will be performed before and twelve weeks after taking the medication. All enrolled women will be randomized to receive nighttime mirabegron, solifenacin, tolterodine or oxybutynin for 12 weeks.
The aims of this study is to obtain the impact of nighttime dosing of mirabegron, solifenacin, tolterodine or oxybutynin versus combined therapy on nocturia, psychologic distress, sexual function, cognition, heart rate variability and bladder blood perfusion in women with overactive bladder syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mirabegron | Active comparator | Drug: Mirabegron 25mgmirabegron 25 mg |
| Solifenacin | Active comparator | Drug: Solifenacin 5 mgSolifenacin 5mg |
| Tolterodine | Active comparator | Drug: Tolterodine 4 mgTolterodine 4mg |
| Oxybutynin ER | Active comparator | Drug: Oxybutynin ER 5 mgOxybutynin ER 5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years old.
- female patients with overactive bladder syndrome
Key exclusion criteria (4 listed)
- Clinically significant dysuria (inability to urinate, difficulty urinating).
- Severe stress urinary incontinence (urinary incontinence caused by coughing).
- Mixed urinary incontinence mainly caused by stress urinary incontinence (urinary incontinence caused by coughing as the main symptom).
- Contraindications to antimuscarinic drugs or adrenergic receptor agonists.
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 25mgTaking 25 mg mirabegron in the nighttime | Drug | mirabegron |
| Solifenacin 5 mgTaking 5 mg solifenacin in the nighttime | Drug | Solifenacin |
| Tolterodine 4 mgTaking 5 mg tolterodine in the nighttime | Drug | Tolterodine |
| Oxybutynin ER 5 mgTaking 5 mg oxybutynin ER in the nighttime | Drug | Oxybutynin ER |
Primary outcome
Improvement of overactive bladder symptoms
Time frame: 12 weeks
Comparisons of the changes of overactive bladder symptom score between groups
2 secondary outcomes
Change of heart rate variability
Time frame: 12 weeks
Change of bladder blood perfusion
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital,
Banqiao District, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mirabegron 25mg, Solifenacin 5 mg and Tolterodine 4 mg in people with Urinary Bladder, Overactive, 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 4 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of overactive bladder symptoms (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 11 Aug 2025.