Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity

ConditionsUrinary Bladder, Overactive Effect of Drug

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age40-90

SponsorMackay Memorial Hospital

About this trial

To investigates the effects of combined pharmacotherapy with solifenacin and mirabegron versus solifenacin with vaginal estrogen cream in women with detrusor overactivity.

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.

Women who were on hormone replacement therapy within 3 months were also excluded from the study

Trial design

Design model

Parallel

Treatments tested in this trial

Solifenacin with vaginal estrogen cream
Drug
Solifenacin 5mg with vaginal conjugated equine estrogen (CEE) 0.625 mg
Combination pharmacotherapy
Drug
Solifenacin 5mg and Mirabegron 25mg

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: Solifenacin with vaginal estrogen creamExperimental treatment 1 intervention

Group B: Combination pharmacotherapyActive comparator 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