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To investigates the effects of botulinum toxin type A bladder injection compared to combined pharmacotherapy with Mirabegron and Solifenacin.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Combination pharmacotherapy | Experimental | Combine Mirabegron and Solifenacin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradetrusor Botox® (onabotulinumtoxinA) injection | Procedure | The toxin produced by Clostridium botulinum binds to the nerves endings and inhibits the muscular contractions, help to treat overactivity of the bladder muscles. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum cystometric capacity | One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity | Assess during 3 months - 1year after treatment |
| Maximum detrusor pressure at first involuntary detrusor contraction |
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Inclusion Criteria:
Exclusion Criteria:
The study focus on female detrusor overactivity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Hsuan Lau, MD | Contact | +886-2-25433535 | huihsuan1220@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui-Hsuan Lau, MD | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Recruiting | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31039103 | Background | 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. | |
| 30644570 | Background | Mueller 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. |
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| Combine Mirabegron and Solifenacin. | Drug | Combination pharmacotherapy |
|
One of the urodynamic measurement commonly used for describing the severity of detrusor overactivity
| 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 | Assess during 3 months - 1year after treatment |
| 40590342 | Derived | Hsieh 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. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007267 | Injections |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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