Overactive BladderNCT07337252
Risk Factors for Treatment Failure in Women With Detrusor Overactivity Receiving Combined Pharmacotherapy
An observational study of Overactive Bladder, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
This study evaluated the outcomes of women with detrusor overactivity treated with combined pharmacotherapy to identify risk factors for treatment failure. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Combined pharmacotherapy
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2022to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study conducted in a tertiary referral hospital located in northern Taiwan.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Overactive Bladder
- Being tested
- Combined pharmacotherapy
- Keywords
- Antimuscarinic, β-agonist, Overactive Bladder, Risk factors, Treatment
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined pharmacotherapyDrug
Combined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Combined pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assess before treatment and 12 weeks after treatment
Secondary outcomes (4)
Episodes of daily micturition
Patients report daily lower urinary tract symptoms episodes
Measured: Assess before treatment and 12 weeks after treatment
Episodes of daily urgency
Patients report daily lower urinary tract symptoms episodes
Measured: Assess before treatment and 12 weeks after treatment
Episodes of daily incontinence
Patients report daily lower urinary tract symptoms episodes
Measured: Assess before treatment and 12 weeks after treatment
Episodes of daily nocturia
Patients report daily lower urinary tract symptoms episodes
Measured: Assess before treatment and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Jun 2022
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsuan Lau, MD, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337252
- Sponsor's protocol ID
- 22MMHIS039e-4
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for the Failure of Combined Pharmacotherapy in Women With Refractory Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT07337252
- Acronym / sponsor ID
- 22MMHIS039e-4
- Conditions
- Overactive Bladder
- Keywords
- Antimuscarinic, β-agonist, Overactive Bladder, Risk factors, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the outcomes of women with detrusor overactivity treated with combined pharmacotherapy to identify risk factors for treatment failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with urodynamic DO refractory to combined pharmacotherapy | – | Drug: Combined pharmacotherapyWe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study conducted in a tertiary referral hospital located in northern Taiwan.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined pharmacotherapyCombined pharmacotherapy with oral solifenacin 5 mg and mirabegron 25 mg once daily. | Drug | Women with urodynamic DO refractory to combined pharmacotherapy |
Primary outcome
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.
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.
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.
4 secondary outcomes
Episodes of daily micturition
Time frame: Assess before treatment and 12 weeks after treatment
Episodes of daily urgency
Time frame: Assess before treatment and 12 weeks after treatment
Episodes of daily incontinence
Time frame: Assess before treatment and 12 weeks after treatment
Episodes of daily nocturia
Time frame: Assess before treatment and 12 weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short form of Urinary Distress Inventory (UDI-6) (time frame: Assess before treatment and 12 weeks after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.