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To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder
Women with detrusor overactivity who were refractory to anti-muscarinics or mirabegron were enrolled for prospective study. Patients were divided into three groups: combined pharmacotherapy with solifenacin and mirabegron, solifenacin with vaginal estrogen cream and mirabegron with vaginal estrogen cream. 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 episodes of daily micturition, urgency, urinary incontinence and nocturia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin and mirabegron | Active Comparator | Solifenacin 5mg and Mirabegron 25mg |
|
| Solifenacin with vaginal estrogen cream | Experimental | Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week. |
|
| Mirabegron with vaginal estrogen cream | Experimental | Mirabegron 25mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined pharmacotherapy with Solifenacin and Mirabegron | Drug | Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist. |
|
| 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 |
|---|---|---|
| Episodes of daily micturition | Patients report daily lower urinary tract symptoms episodes | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment |
| Episodes of daily urgency |
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Inclusion Criteria:
Exclusion Criteria:
The study focus on female overactive bladder.
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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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|
| Solifenacin with vaginal estrogen cream | Drug | Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg). |
|
|
| Mirabegron with vaginal estrogen cream | Drug | Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg). |
|
|
Patients report daily lower urinary tract symptoms episodes
| Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment |
| Episodes of daily incontinence | Patients report daily lower urinary tract symptoms episodes | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment |
| Episodes of daily nocturia | Patients report daily lower urinary tract symptoms episodes | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment |
| 15453881 | Background | Cardozo L, Lose G, McClish D, Versi E. A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder. Acta Obstet Gynecol Scand. 2004 Oct;83(10):892-7. doi: 10.1111/j.0001-6349.2004.00581.x. |
| 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 |
|---|---|
| D000069464 | Solifenacin Succinate |
| C520025 | mirabegron |
| D004966 | Estrogens, Conjugated (USP) |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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