Urinary Bladder, OveractivePhase 4NCT05968885
Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
A Phase 4 study testing Intradetrusor Botox® (onabotulinumtoxinA) injection and Combine Mirabegron and Solifenacin. in people with Urinary Bladder, Overactive and Urodynamics, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin. Read more about this study
- Who is it for?
- Ages 20 to 90 years, women only
- Conditions the study is for
- Urinary Bladder, Overactive, Urodynamics, Effect of Drug
- What is being tested?
- Intradetrusor Botox® (onabotulinumtoxinA) injection and Combine Mirabegron and Solifenacin.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 31 Dec 2026
- Phase
- Phase 4
- 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 20 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study
Who cannot join
- Postvoid urine retention before treatment
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, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei
Jiun Chyi Hwang, MD, +886-2-2543-3535, jiun1989@gmail.com
About this study
Official title: Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Read the detailed description
Patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.
- Conditions
- Urinary Bladder, Overactive, Urodynamics, Effect of Drug
- Being tested
- Intradetrusor Botox® (onabotulinumtoxinA) injection, Combine Mirabegron and Solifenacin.
- Keywords
- Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradetrusor Botox® (onabotulinumtoxinA) injectionProcedure or surgery
The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles.
Combine Mirabegron and Solifenacin.Drug
Combination pharmacotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intradetrusor onabotulinumtoxinA injection | Active comparator | The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles. Receives: Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injection |
| Combination pharmacotherapy | Experimental | Combine Mirabegron and Solifenacin. Receives: Drug: Combine Mirabegron and Solifenacin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short form of Urinary Distress Inventory (UDI-6)
UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.
Measured: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Short form of Incontinence Impact Questionnaire (IIQ-7)
The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships \& emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.
Measured: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Overactive Bladder Symptom Score (OABSS)
The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.
Measured: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
Secondary outcomes (3)
Maximum cystometric capacity
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Measured: Assess during 3 months - 1year after treatment
Maximum detrusor pressure at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Measured: Assess during 3 months - 1year after treatment
Volume at first involuntary detrusor contraction
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
Measured: Assess during 3 months - 1year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Oct 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsuan Lau, MD, Mackay Memorial Hospital
- Investigators
- Hui-Hsuan Lau, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968885
- Sponsor's protocol ID
- 22MMHIS039e
- Status last verified
- Dec 2024
- First submitted
- 2 Mar 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
PubMed 31039103Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.
PubMed 30644570Hsieh MH, Hwang JC, Su TH, Lau HH. The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial. J Urol. 2025 Oct;214(4):344-353. doi: 10.1097/JU.0000000000004660. Epub 2025 Jul 1.
PubMed 40590342
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Urodynamic Outcomes Between Intradetrusor onabotulinumtoxinA Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT05968885
- Acronym / sponsor ID
- 22MMHIS039e
- Conditions
- Urinary Bladder, Overactive, Urodynamics, Effect of Drug
- Keywords
- Detrusor overactivity, Urodynamic study, Combined pharmacotherapy, Botulinum Toxins, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 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.
To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
Detailed description
Patients with detrusor overactivity who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study. Patient were divided in two groups, intradetrusor onabotulinumtoxinA injection and combined pharmacotherapy with Mirabegron and Solifenacin. Incontinence-related symptoms distress and impact on quality of life were evaluated by short form of Urinary Distress Inventory, (UDI-6), Incontinence Impact Questionnaire (IIQ-7) and Overactive Bladder Symptom Score (OABSS). Objective outcomes include changes from baseline in daily urgency episodes, urinary incontinence episodes, maximum cystometric capacity, maximum detrusor pressure (Pdetmax) at first involuntary detrusor contraction and volume at first involuntary detrusor contraction were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intradetrusor onabotulinumtoxinA injection | Active comparator | Procedure: Intradetrusor Botox® (onabotulinumtoxinA) injectionThe toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles. |
| Combination pharmacotherapy | Experimental | Drug: Combine Mirabegron and Solifenacin.Combine Mirabegron and Solifenacin. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with detrusor overactivity which defined as a urodynamic observation characterized by involuntary detrusor contractions during the filling phase. Those who were refractory to monotherapy with either anti-muscarinics or β3-adrenoceptor agonists were enrolled for prospective study
Key exclusion criteria (1 listed)
- Postvoid urine retention before treatment
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 |
|---|---|---|
| Intradetrusor Botox® (onabotulinumtoxinA) injectionThe toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles. | Procedure or surgery | Intradetrusor onabotulinumtoxinA injection |
| Combine Mirabegron and Solifenacin.Combination pharmacotherapy | Drug | Combination pharmacotherapy |
Primary outcome
Short form of Urinary Distress Inventory (UDI-6)
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
UDI-6 is a valid questionnaire, used particularly to investigate symptoms associated with lower urinary tract dysfunction and inquire on irritative, stress, and obstructive or discomfort complaints. UDI-6 consists of six items: frequent urination; leakage related to feeling of urgency; leakage related to activity, coughing, or sneezing; small amounts of leakage (drops); difficulty emptying the bladder; and pain or discomfort in the lower abdominal or genital area. The total score ranges from 0 to 18 , with a higher score indicating more severe of incontinence.
Short form of Incontinence Impact Questionnaire (IIQ-7)
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
The IIQ-7 assess the impact of urinary incontinence on QoL. 7 items assess influence of urinary incontinence on physical activity, travel, social/relationships \& emotional health. Each item is scored between 0 (activities not affected at all) to 3 (activities greatly affected). The total score ranges from 0 to 21, with a higher score indicating more severe of incontinence.
Overactive Bladder Symptom Score (OABSS)
Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment
The total OABSS is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The total score ranges from 0 to 15, with a higher score indicating more severe of OAB symptoms.
3 secondary outcomes
Maximum cystometric capacity
Time frame: Assess during 3 months - 1year after treatment
Maximum detrusor pressure at first involuntary detrusor contraction
Time frame: Assess during 3 months - 1year after treatment
Volume at first involuntary detrusor contraction
Time frame: Assess during 3 months - 1year after treatment
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 9 May 2025.
- Background: PubMed 31039103Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
- Background: PubMed 30644570Mueller ER, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Stoelzel M, Yoon SJ, Al-Shukri S, Rechberger T, Gratzke C. Long-term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study. Neurourol Urodyn. 2019 Feb;38(2):779-792. doi: 10.1002/nau.23919. Epub 2019 Jan 15.
- Derived from this study: PubMed 40590342Hsieh MH, Hwang JC, Su TH, Lau HH. The Efficacy and Safety Between Intradetrusor OnabotulinumtoxinA Injection and Combined Pharmacotherapy in Patients With Refractory Overactive Bladder: A Randomized Controlled Trial. J Urol. 2025 Oct;214(4):344-353. doi: 10.1097/JU.0000000000004660. Epub 2025 Jul 1.
- 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.
Hui-Hsuan Lau, MD principal investigator
Mackay Memorial Hospital
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 Intradetrusor Botox® (onabotulinumtoxinA) injection and Combine Mirabegron and Solifenacin. in people with Urinary Bladder, Overactive and Urodynamics, run by Mackay 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: looking for participants now, as of the sponsor's last update on 9 May 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 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?
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?
Contact Hui-Hsuan Lau, MD (+886-2-25433535, huihsuan1220@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short form of Urinary Distress Inventory (UDI-6) (time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment). The study lists 3 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 NCT05968885, which also lists 3 linked publications.
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 9 May 2025.