Risk Factors for Treatment Failure in Women With Detrusor Overactivity Receiving Combined Pharmacotherapy

Mackay Memorial Hospital61 enrolled

Overview

This study evaluated the outcomes of women with detrusor overactivity treated with combined pharmacotherapy to identify risk factors for treatment failure.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Overactive Bladder

Interventions

Combined pharmacotherapyDRUG

Combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily.

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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 either anticholinergics or β3-agonist medication for at least 1 month. Exclusion Criteria: * Neurological conditions or spinal cord injury, which could affect urologic function * Advanced pelvic organ prolapse (pelvic organ prolapse quantification system stage II or above) * Active urinary tract infection * Contraindications to taking anticholinergic and β3-agonist medications

Locations (1)

Mackay Memorial Hospital

Taipei, Taiwan

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: Assess before treatment and 12 weeks after treatment

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.

Time frame: Assess before treatment and 12 weeks after treatment

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.

Time frame: Assess before treatment and 12 weeks after treatment

Secondary Outcomes

Episodes of daily micturition

Patients report daily lower urinary tract symptoms episodes

Time frame: Assess before treatment and 12 weeks after treatment

Episodes of daily urgency

Patients report daily lower urinary tract symptoms episodes

Data from ClinicalTrials.gov

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