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Completed

NCT Number: NCT07337252

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

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

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Sex eligibility

Female

Study type

Observational

Primary location

Mackay Memorial Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined pharmacotherapy

Drug

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

Primary outcomes

  1. Short form of Urinary Distress Inventory (UDI-6)

    Time frame: Assess before treatment and 12 weeks after treatment

    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.

  2. Short form of Incontinence Impact Questionnaire (IIQ-7)

    Time frame: Assess before treatment and 12 weeks after treatment

    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.

  3. Overactive Bladder Symptom Score (OABSS)

    Time frame: Assess before treatment and 12 weeks after treatment

    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.

Secondary outcomes

  1. Episodes of daily micturition

    Time frame: Assess before treatment and 12 weeks after treatment

    Patients report daily lower urinary tract symptoms episodes

  2. Episodes of daily urgency

    Time frame: Assess before treatment and 12 weeks after treatment

    Patients report daily lower urinary tract symptoms episodes

  3. Episodes of daily incontinence

    Time frame: Assess before treatment and 12 weeks after treatment

    Patients report daily lower urinary tract symptoms episodes

  4. Episodes of daily nocturia

    Time frame: Assess before treatment and 12 weeks after treatment

    Patients report daily lower urinary tract symptoms episodes

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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