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To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Women with detrusor overactivity who were refractory to anti-muscarinics were enrolled for prospective study. Patients were divided into two groups: one receive combined pharmacotherapy with solifenacin and mirabegron, and the other received solifenacin and 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 with vaginal estrogen cream | Experimental | Solifenacin 5mg once per day with vaginal conjugated equine estrogen (CEE) 0.625 mg twice a week. |
|
| Combination pharmacotherapy | Active Comparator | Combined solifenacin 5mg and mirabegron 25mg once per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solifenacin with vaginal estrogen cream | Drug | Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg |
|
| 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 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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| Combination pharmacotherapy | Drug | Solifenacin 5mg and Mirabegron 25mg |
|
|
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 |
| D004966 | Estrogens, Conjugated (USP) |
| D004359 | Drug Therapy, Combination |
| C520025 | mirabegron |
| 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 |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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