Overactive BladderPhase 1ACWMITTOOABNCT06181019
Acupuncture Combined With Mirabegron in the Treatment of OAB
A Phase 1 study testing 50 mg of mirabegron and acupuncture combined with mirabegron. in people with Overactive Bladder, run by The Affiliated Ganzhou Hospital of Nanchang University at 1 site in China.
Trial summary
Introduction: As conventional treatments for overactive bladder (OAB) have not yet shown satisfactory results, new approaches are needed. Therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of OAB. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- 50 mg of mirabegron and acupuncture combined with mirabegron.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2024
- Phase
- Phase 1
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of OAB
- Good compliance
- Good communication skills
Who cannot join
- Age <14 or >75 years
- History of use of M-blockers in the recent 4-6 weeks
- History of use of α-blockers in the recent 4-6 weeks
- History of use of mirabegron in the recent 4-6 weeks
- Diagnosis with a combined urinary tract tumor
- Inability to cooperate with this study
- Pregnancy
- Postvoid residual urine volume >150 mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial
Introduction: As conventional treatments for overactive bladder (OAB) have not yet shown satisfactory results, new approaches are needed. Therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of OAB.
Methods: This prospective cohort study enrolled 80 OAB patients who were then divided into control and treatment groups using a randomized number-table method. The control group was administered mirabegron alone (50 mg/day), while the treatment group was administered mirabegron orally along with acupuncture at the following points: guanyuan (CV4), zhongji (CV3), and sanyinjiao (SP6). The OAB symptom score (overactive bladder syndrome score [OABSS]), voiding, urgency, nocturia, incontinence, and incidence of related adverse events were compared between the two groups at baseline and after 4, 8, and 12 weeks of treatment.
- Conditions
- Overactive Bladder
- Being tested
- 50 mg of mirabegron, acupuncture combined with mirabegron.
- Keywords
- overactive bladder, mirabegron, acupuncture, nocturia, incontinence
- 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.
50 mg of mirabegronDrug
Also called mirabegron
Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks.
acupuncture combined with mirabegron.Combination product
Patients in the treatment group were treated with acupuncture combined with mirabegron.
| Study group | Role | What they receive |
|---|---|---|
| Be treated with mirabegron. | Active comparator | Patients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. Receives: Drug: 50 mg of mirabegron |
| Be treated with acupuncture combined with mirabegron. | Experimental | Patients were treated with acupuncture combined with mirabegron. Receives: Combination Product: acupuncture combined with mirabegron. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive bladder syndrome scores (OABSS)
overactive bladder syndrome scores of patient
Measured: 4, 8, and 12 weeks after treatment
voiding diary indicators (voiding, urgency, nocturia, and incontinence)
Number of voiding, urgency, nocturia, and incontinence in one day
Measured: 4, 8, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Dec 2021
- Primary completion31 Mar 2023
- 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 BladderStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks, whereas patients in the treatment group were treated with acupuncture combined with mirabegron.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Ganzhou Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huang Xin, The Affiliated Ganzhou Hospital of Nanchang University
- Investigators
- Xiaolin Deng, M.D., Principal investigator, Ganzhou City People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181019
- Sponsor's protocol ID
- TY-ZKY-2023-045-01
- Acronym
- ACWMITTOOAB
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Combined With Mirabegron in the Treatment of Overactive Bladder Syndrome: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06181019
- Acronym / sponsor ID
- ACWMITTOOAB / TY-ZKY-2023-045-01
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, mirabegron, acupuncture, nocturia, incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Affiliated Ganzhou Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Dec 2023 (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.
Introduction: As conventional treatments for overactive bladder (OAB) have not yet shown satisfactory results, new approaches are needed. Therefore, this study aimed to investigate the efficacy and safety of acupuncture combined with mirabegron for the treatment of OAB.
Methods: This prospective cohort study enrolled 80 OAB patients who were then divided into control and treatment groups using a randomized number-table method. The control group was administered mirabegron alone (50 mg/day), while the treatment group was administered mirabegron orally along with acupuncture at the following points: guanyuan (CV4), zhongji (CV3), and sanyinjiao (SP6). The OAB symptom score (overactive bladder syndrome score [OABSS]), voiding, urgency, nocturia, incontinence, and incidence of related adverse events were compared between the two groups at baseline and after 4, 8, and 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks, whereas patients in the treatment group were treated with acupuncture combined with mirabegron.
| Arm | Type | Receives |
|---|---|---|
| Be treated with mirabegron. | Active comparator | Drug: 50 mg of mirabegronPatients were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. |
| Be treated with acupuncture combined with mirabegron. | Experimental | Combination Product: acupuncture combined with mirabegron.Patients were treated with acupuncture combined with mirabegron. |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of OAB
- Good compliance
- Good communication skills
Key exclusion criteria (8 listed)
- Age <14 or >75 years
- History of use of M-blockers in the recent 4-6 weeks
- History of use of α-blockers in the recent 4-6 weeks
- History of use of mirabegron in the recent 4-6 weeks
- Diagnosis with a combined urinary tract tumor
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 |
|---|---|---|
| 50 mg of mirabegronAlso: mirabegronPatients in the control group were treated with 50 mg of mirabegron (Astellas Pharma, Tokyo, Japan) for 12 weeks. | Drug | Be treated with mirabegron. |
| acupuncture combined with mirabegron.Patients in the treatment group were treated with acupuncture combined with mirabegron. | Combination product | Be treated with acupuncture combined with mirabegron. |
Primary outcome
Overactive bladder syndrome scores (OABSS)
Time frame: 4, 8, and 12 weeks after treatment
overactive bladder syndrome scores of patient
voiding diary indicators (voiding, urgency, nocturia, and incontinence)
Time frame: 4, 8, and 12 weeks after treatment
Number of voiding, urgency, nocturia, and incontinence in one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Xiaolin Deng, M.D. principal investigator
Ganzhou City People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 50 mg of mirabegron and acupuncture combined with mirabegron. in people with Overactive Bladder, run by The Affiliated Ganzhou Hospital of Nanchang University at 1 site in China.
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 3 inclusion and 8 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 26 Dec 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Overactive bladder syndrome scores (OABSS) (time frame: 4, 8, and 12 weeks after treatment). 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 26 Dec 2023.