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

ConditionsEffect of Drug Urinary Bladder, Overactive

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age40-90

SponsorMackay Memorial Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Combined pharmacotherapy with Solifenacin and Mirabegron
Drug
Solifenacin (5mg) is anticholinergic and Mirabegron (25mg) is a beta-3 adrenergic agonist.
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).

Treatment groups

300 Participants

are divided into 3 treatment groups

Group A: Solifenacin and mirabegronActive comparator 1 intervention

Group B: Solifenacin with vaginal estrogen creamExperimental treatment 1 intervention

Group C: Mirabegron with vaginal estrogen creamExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame