Overactive Bladder SyndromePhase 4NCT02540707
Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes
A Phase 4 study testing solifenacin and mirabegron in people with Overactive Bladder Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic distress. However, there is no such research for the new drug- mirabegron (a β3-agonist). Read more about this study
- Who is it for?
- Ages 20 to 99 years, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- solifenacin and mirabegron
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Sep 2015to 26 Aug 2020
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with overactive bladder syndrome
- ≥20 year-old
Who cannot join
- Urine retention,
- acute angle glaucoma,
- myasthenia gravis,
- ulcerative colitis,
- megacolon
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Outpatient clinics, Department of Obs/Gyn, National Taiwan University Hospital
Taipei, 100
About this study
Official title: Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial
Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic distress. However, there is no such research for the new drug- mirabegron (a β3-agonist). Thus, the aim of our study is to analyze the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups.
Patients and Methods: The investigators will perform a prospective randomized controlled study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, UDI-6 \& IIQ-7, Patient Health Questionnaire, brief symptom rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership, growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire, standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron versus solifenacin treatment. STATA software is used for statistical analyses.
Possible Results: The investigators can answer that the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. The above conclusions should be important for pre-treatment consultation.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- solifenacin, mirabegron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacinDrug
solifenacin 5 mg per day for 12 weeks
mirabegronDrug
mirabegron 25 mg per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin | Placebo comparator | Women with overactive bladder syndrome will be treated by solifenacin 5 mg qd * 12 weeks Receives: Drug: solifenacin |
| Mirabegron | Experimental | Women with overactive bladder syndrome will be treated by mirabegron 25 mg qd * 12 weeks Receives: Drug: mirabegron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference of the effect of drug on heart rate variability
Between-group difference of the effect of drug on heart rate variability, such as low frequency and high frequency
Measured: 12 weeks
Between-group difference of the effect of drug on psychosomatic distress
Between-group difference of the effect of drug on psychosomatic distress by Brief Symptom Rating Scale
Measured: 12 weeks
Secondary outcomes (2)
Between-group difference of the effect of drug on arterial stiffness
Between-group difference of the effect of drug on arterial stiffness by cardio-ankle vascular index
Measured: 12 weeks
Between-group difference of the effect of drug on clinical efficacy
Between-group difference of the effect of drug on clinical efficacy by Overactive Bladder Symptoms Score Questionnaire
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 posted4 Sep 2015 (estimated)
- Study start8 Sep 2015
- Primary completion26 Aug 2020
- Study completion26 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540707
- Sponsor's protocol ID
- 201506092MIND
- Status last verified
- Mar 2023
- First submitted
- 27 Aug 2015
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02540707
- Acronym / sponsor ID
- 201506092MIND
- Conditions
- Overactive Bladder Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 26 Aug 2020 (actual)
- Study completion
- 26 Aug 2020 (actual)
- First posted
- 4 Sep 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.
Background/Purpose: The overactive bladder syndrome (OAB) affects around 17 % of female population. Antimuscarinics can affect autonomic system, arterial stiffness and psychosomatic distress. However, there is no such research for the new drug- mirabegron (a β3-agonist). Thus, the aim of our study is to analyze the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups.
Patients and Methods: The investigators will perform a prospective randomized controlled study to recruit 150 female OAB patients at the outpatient clinic of Department of Obstetrics and Gynecology of National Taiwan University Hospital. All OAB female patients will be asked to complete Urgency Severity Scales, Overactive Bladder Symptoms Scores questionnaires, King's Health questionnaires, UDI-6 \& IIQ-7, Patient Health Questionnaire, brief symptom rating scale (BSRS), Maudsley personality inventory (MPI) and adaptability, partnership, growth, affection, and resolve (APGAR) questionnaires, Sleep and Dietary habit Questionnaire, standard 12-leads electrocardiography (ECG), 5 minutes Holter monitoring, cardio-ankle vascular index (CAVI) test, bladder diary, 20-min pad test, urodynamic studies and measurement of urinary nerve growth factors level before and after 12 weeks' mirabegron versus solifenacin treatment. STATA software is used for statistical analyses.
Possible Results: The investigators can answer that the between-group differences in heart rate variability, cardio-ankle vascular index, ankle-brachial pressure index, psychosomatic distress, personality trait, family support and clinical outcomes between the mirabegron and the solifenacin groups. The above conclusions should be important for pre-treatment consultation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Solifenacin | Placebo comparator | Drug: solifenacinWomen with overactive bladder syndrome will be treated by solifenacin 5 mg qd * 12 weeks |
| Mirabegron | Experimental | Drug: mirabegronWomen with overactive bladder syndrome will be treated by mirabegron 25 mg qd * 12 weeks |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with overactive bladder syndrome
- ≥20 year-old
Key exclusion criteria (5 listed)
- Urine retention,
- acute angle glaucoma,
- myasthenia gravis,
- ulcerative colitis,
- megacolon
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 |
|---|---|---|
| solifenacinsolifenacin 5 mg per day for 12 weeks | Drug | Solifenacin |
| mirabegronmirabegron 25 mg per day for 12 weeks | Drug | Mirabegron |
Primary outcome
Between-group difference of the effect of drug on heart rate variability
Time frame: 12 weeks
Between-group difference of the effect of drug on heart rate variability, such as low frequency and high frequency
Between-group difference of the effect of drug on psychosomatic distress
Time frame: 12 weeks
Between-group difference of the effect of drug on psychosomatic distress by Brief Symptom Rating Scale
2 secondary outcomes
Between-group difference of the effect of drug on arterial stiffness
Time frame: 12 weeks
Between-group difference of the effect of drug on clinical efficacy
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 28 Mar 2023.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
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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 solifenacin and mirabegron in people with Overactive Bladder Syndrome, run by National Taiwan University 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 5 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 28 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. Some participants in this study may receive a placebo. 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 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?
Between-group difference of the effect of drug on heart rate variability (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?
On the ClinicalTrials.gov record for NCT02540707, which also lists 1 linked publication.
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 28 Mar 2023.