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Recruiting NCT06479720

Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder

Phase IV Interventional Effect of Drug Urinary Bladder, Overactive

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: Combined pharmacotherapy with Solifenacin and Mirabegron, Solifenacin with vaginal estrogen cream, Mirabegron with vaginal estrogen cream.
Who it may be relevant to
Registry conditions: Effect of Drug, Urinary Bladder, Overactive. 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 →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Solifenacin or Mirabegron With Local Estrogen Versus Combination Treatment With Mirabegron and Solifenacin for Refractory Overactive Bladder

Overview

To investigates the effects of solifenacin or mirabegron with local estrogen versus combination treatment with solifenacin and mirabegron in women with overactive bladder

Detailed description

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.

Interventions

  • Drug Combined pharmacotherapy with Solifenacin and Mirabegron
    Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.
  • Drug Solifenacin with vaginal estrogen cream
    Solifenacin (5mg) is anticholinergic. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).
  • Drug Mirabegron with vaginal estrogen cream
    Mirabegron (25mg) is a beta-3 adrenergic agonist. Premarin, vaginal conjugated equine estrogen vaginal cream (0.625 mg).

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.

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: NCT06479720 · 22MMHIS039e-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗