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

Risk Factors for the Failure of Combined Pharmacotherapy in Women With Refractory Detrusor Overactivity

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07337252
Enrollment
61
Registered
2026-01-13
Start date
2022-06-01
Completion date
2024-08-31
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Antimuscarinic, β-agonist, Overactive Bladder, Risk factors, Treatment

Brief summary

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

Interventions

DRUGCombined pharmacotherapy

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

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short form of Urinary Distress Inventory (UDI-6)Assess before treatment and 12 weeks after treatmentUDI-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.
Short form of Incontinence Impact Questionnaire (IIQ-7)Assess before treatment and 12 weeks after treatmentThe 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.
Overactive Bladder Symptom Score (OABSS)Assess before treatment and 12 weeks after treatmentThe 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.

Secondary

MeasureTime frameDescription
Episodes of daily micturitionAssess before treatment and 12 weeks after treatmentPatients report daily lower urinary tract symptoms episodes
Episodes of daily nocturiaAssess before treatment and 12 weeks after treatmentPatients report daily lower urinary tract symptoms episodes
Episodes of daily urgencyAssess before treatment and 12 weeks after treatmentPatients report daily lower urinary tract symptoms episodes
Episodes of daily incontinenceAssess before treatment and 12 weeks after treatmentPatients report daily lower urinary tract symptoms episodes

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026