NCT07337252

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 1, 2026

Last Update Submit

January 1, 2026

Conditions

Overactive Bladder

Keywords

Antimuscarinicβ-agonistOveractive BladderRisk factorsTreatment

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Episodes of daily micturition

    Assess before treatment and 12 weeks after treatment

  • Episodes of daily urgency

    Assess before treatment and 12 weeks after treatment

  • Episodes of daily incontinence

    Assess before treatment and 12 weeks after treatment

  • Episodes of daily nocturia

    Assess before treatment and 12 weeks after treatment

Study Arms (1)

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

Interventions

Combined pharmacotherapyDRUG

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

Women with urodynamic DO refractory to combined pharmacotherapy

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study focus on female overactive bladder.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mackay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of urogynecology, Associate Professor

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 13, 2026

Study Start

June 1, 2022

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

January 13, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)