Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solifenacin with vaginal estrogen cream, Combination pharmacotherapy.
- Who it may be relevant to
- Registry conditions: Urinary Bladder, Overactive, Effect of Drug. Basic parameters: 40 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Solifenacin Combined With Mirabegron Versus Solifenacin With Vaginal Estrogen Cream for the Treatment of Detrusor Overactivity
Overview
To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.
Detailed description
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.
Interventions
- Drug Solifenacin with vaginal estrogen cream
Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg - Drug Combination pharmacotherapy
Solifenacin 5mg and Mirabegron 25mg
Primary outcome measures
- 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]
- 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]
- Overactive Bladder Symptom Score (OABSS) [Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
Secondary outcome measures (4)
- Episodes of daily micturition [Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
- Episodes of daily urgency [Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
- Episodes of daily incontinence [Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
- Episodes of daily nocturia [Time frame: Assess before treatment and 1 month, 3 months, 6 months and 1 year after treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Mackay Memorial Hospital — Taipei
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. PMID 31039103
- 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. PMID 30644570
- 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. PMID 15453881
Identifiers
NCT: NCT06197295 · 22MMHIS039e-2