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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Combined pharmacotherapy

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study conducted in a tertiary referral hospital located in northern Taiwan.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with urodynamic DO refractory to combined pharmacotherapy; We enrolled women with refractory detrusor overactivity, defined as ongoing symptoms after at least 1 month of treatment with either an anticholinergic or a β3-agonist. Eligible women received combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily for 12 weeks.	Drug: Combined pharmacotherapy; Combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Assess before treatment and 12 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodes of daily micturition	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 12 weeks after treatment
Episodes of daily urgency	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 12 weeks after treatment
Episodes of daily incontinence	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 12 weeks after treatment
Episodes of daily nocturia	Patients report daily lower urinary tract symptoms episodes	Assess before treatment and 12 weeks after treatment

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: January 1, 2026
• First Submitted That Met QC Criteria: January 1, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Treatment; Overactive Bladder; Antimuscarinic; Risk factors; β-agonist
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive
• Other Study ID Numbers: 22MMHIS039e-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes