Urinary Bladder, Overactive Clinical Trial
Official title:
Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - 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 anti-muscarinics were enrolled for prospective study. Exclusion Criteria: - Postvoid urine retention before treatment - Women who had medical illness and contraindication for using solifenacin and mirabegron, such as narrow-angle glaucoma and hypertension - Concerns for using estrogen include: Women with history of cerebrovascular disease; thromboembolic disorders; gallbladder disease; known or suspected breast carcinoma; estrogen-dependent neoplasm or undiagnosed abnormal genital bleeding. - Women who were on hormone replacement therapy within 3 months were also excluded from the study |
Country | Name | City | State |
---|---|---|---|
Taiwan | Mackay Memorial Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Mackay Memorial Hospital |
Taiwan,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Episodes of daily urgency | Patients report daily lower urinary tract symptoms episodes | Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment | |
Secondary | 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 | |
Secondary | 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 |
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