Overactive Bladder SyndromePhase 4NCT05188742
Sequencing and Combination of Mirabegron and TTNS in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
A Phase 4 study testing mirabegron and TTNS in people with Overactive Bladder Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Research question: A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- mirabegron and TTNS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Nov 2021to Sep 2023
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult OAB patients ≥20 years
- Diagnosed with moderate to severe OAB (with or without urgency incontinence) based on OABSS >5 and clinical assessment, with UUI-predominant presentation, for at least 3 months
- Able to receive TTNS and accommodate treatment logistics (30 min per on-site session, twice weekly)
- Provided informed consent to participate in the study
Who cannot join
- Neurologic conditions associated with OAB symptoms
- History of stress urinary incontinence
- Use of intravesical onabotulinumoxinA within recent 6 months
- Postvoid residual urine volume (PVR) ≥ 100mL
- Evidence of active urinary tract infection or urinary tract stone at screening
- Genitourinary tract operation during the 3-month period prior to baseline
Show all 14Show fewer
- Confirmed or suspected genitourinary tract or pelvic malignancy
- History of uncontrolled hypertension (systolic >160 mmHg and/or diastolic >110 mmHg)
- History of intolerance to mirabegron
- Patients with pacemakers or implantable defibrillators
- Patients prone to excessive bleeding
- Patients with nerve damage that could impact percutaneous tibial nerve or pelvic floor function
- Patients who are pregnant or planning to become pregnant during the duration of treatment
- History of medical conditions or presence of patient factors that, in the judgement of the investigator, would preclude adherence to study protocol
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Chih-Chieh Lin, MD/Phd, +886-2-2875-7808, jayslylin@gmail.com
About this study
Official title: Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
Research question:
A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. The primary aim of this trial is to answer the questions: how does varying the treatment sequence involving mirabegron and transcutaneous tibial nerve stimulation (TTNS) affect efficacy and patient acceptance and what is the second-line efficacy of either treatment modality?
Read more
Primary objective:
To evaluate improvement in storage symptoms, as measured by changes in Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS) and parameters of voiding diary, in overactive bladder (OAB) patients receiving mirabegron or TTNS as first-line therapy when crossed over to second-line therapy with the opposite treatment modality
Secondary objectives:
To evaluate improvement in symptoms, as measured by changes in OABSS, IPSS and parameters of voiding diary, on first-line therapy with mirabegron or TTNS followed by combination multi-modal therapy To evaluate the effect of multi-modal treatment approach on patient's perception of treatment satisfaction and symptom control To evaluate urodynamic profiles of patients treated with multi-modal approach
Read the detailed description
Study design: Prospective, randomized, multicenter, open-label, cross-over trial Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B
Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks
Patient population: adults ≥ 20 years who have experienced symptoms of OAB, as defined by International Continence Society (ICS) diagnostic criteria, for at least 3 months
Sample size: approximately 180 patients
- Conditions
- Overactive Bladder Syndrome
- Being tested
- mirabegron, TTNS
- Keywords
- overactive bladder, mirabegron, transcutaneous tibial nerve stimulation
- 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.
mirabegronDrug
mirabegron 50mg QD
TTNSProcedure or surgery
transcutaneous tibial nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | mirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks Receives: Drug: mirabegron; Procedure: TTNS |
| Sequence B | Experimental | TTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks Receives: Drug: mirabegron; Procedure: TTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome). Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
Measured: Baseline and Week 20
Secondary outcomes (21)
Changes from baseline to Week 12 in OABSS
Changes from baseline to Week 12 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome)
Measured: Baseline and Week 12
Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS
Changes from baseline in IPSS (International Prostate Symptom Score) at Week 12 and 20 (a lower IPSS represents a better outcome)
Measured: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 Hours
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Measured: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from a micturition diary in which a patient records for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Measured: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) is derived from episodes reocrded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Measured: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 Hours
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a micturition diary in which a patient completes for 3 days prior to clinic visits at Baseline and Week 12 and 20/end of treatment (EoT).
Measured: Baseline, and Week 12 and 20
Changes from Week 8 to Week 20 in OABSS
Changes from Week 8 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
Measured: Week 8 to Week 20
Changes from Week 8 to Week 20 in IPSS
Changes from Week 8 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
Measured: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Micturitions per 24 Hours
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
Measured: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
Measured: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
Measured: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
Measured: Week 8 to Week 20
Changes from Week 12 to Week 20 in OABSS
Changes from Week 12 to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS represents a better outcome)
Measured: Week 12 to Week 20
Changes from Week 12 to Week 20 in IPSS
Changes from Week 12 to Week 20 in IPSS (International Prostate Symptom Score) (a lower IPSS represents a better outcome)
Measured: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Micturitions per 24 Hours
The average number of micturitions (urinations) per 24 hours is derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a 3-day micturition diary.
Measured: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
Nocturia is defined as waking at night one or more times to void. The average number of times a patient urinates (excluding incontinence only episodes) during sleeping time per day is derived from the 3-day patient micturition diary.
Measured: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
The average number of urgency episodes (the sudden, compelling desire to pass urine that is difficult to defer) derived from episodes recorded by the patient in a 3-day micturition diary
Measured: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
The involuntary leakage of urine accompanied or immediately proceeded by urgency, derived from the number of incontinence episodes recorded by the patient in a 3-day micturition diary
Measured: Week 12 to Week 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) is a participant-reported instrument consisting of 19 items that assess the degree to which a participant is bothered by OAB symptoms, and the degree of impact of OAB symptoms on daily life. Participants rate each item using a 6-point Likert Scale ranging from "Not at all" to "A very great deal" for the symptom bother items and "none of the time" to "All of the time" for the Health Related Quality of Life (HRQL) items.
Measured: Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Bladder Assessment Tool (BAT) score
Bladder Assessment Tool (BAT) is a participant-reported instrument consisting of 17 questions regarding the symptoms, bothering, impacts and treatment satisfaction in the past 7 days. Scores range from 0 to 88, a reduction in BAT score indicates an improvement.
Measured: Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
Treatment Satisfaction-Visual Analog Scale (TS-VAS) is a quantitative instrument assessing participant improvement in participants with OAB. A score of 10 on the TS-VAS indicates complete satisfaction, whereas a positive change from baseline indicates improvement.
Measured: Baseline, and Week 12 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start10 Nov 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B Sequence A: mirabegron 50mg monotherapy x 8 weeks -\> multi-modal combination treatment x 4 weeks -\> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -\> multi-modal combination treatment x 4 weeks -\> mirabegron 50mg monotherapy x 8 weeks
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chih-Chieh Lin, MD/Phd, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188742
- Sponsor's protocol ID
- 2021-09-003B
- Status last verified
- Dec 2021
- First submitted
- 22 Nov 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequencing and Combination of Mirabegron and Transcutaneous Tibial Nerve Stimulation (TTNS) in Overactive Bladder Syndrome: a Multicenter, Randomized, Open-label, Crossover Trial
- ClinicalTrials.gov ID
- NCT05188742
- Acronym / sponsor ID
- 2021-09-003B
- Conditions
- Overactive Bladder Syndrome
- Keywords
- overactive bladder, mirabegron, transcutaneous tibial nerve stimulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 10 Nov 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 12 Jan 2022 (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.
Research question:
A wealth of existing research has established the independent effectiveness of mirabegron and neuromodulation in the treatment of overactive bladder syndrome. Optimizing the use of these effective and well-tolerated treatment modalities is an important clinical goal and warrants further research. The primary aim of this trial is to answer the questions: how does varying the treatment sequence involving mirabegron and transcutaneous tibial nerve stimulation (TTNS) affect efficacy and patient acceptance and what is the second-line efficacy of either treatment modality?
Primary objective:
To evaluate improvement in storage symptoms, as measured by changes in Overactive Bladder Symptom Score (OABSS), International Prostate Symptom Score (IPSS) and parameters of voiding diary, in overactive bladder (OAB) patients receiving mirabegron or TTNS as first-line therapy when crossed over to second-line therapy with the opposite treatment modality
Secondary objectives:
To evaluate improvement in symptoms, as measured by changes in OABSS, IPSS and parameters of voiding diary, on first-line therapy with mirabegron or TTNS followed by combination multi-modal therapy To evaluate the effect of multi-modal treatment approach on patient's perception of treatment satisfaction and symptom control To evaluate urodynamic profiles of patients treated with multi-modal approach
Detailed description
Study design: Prospective, randomized, multicenter, open-label, cross-over trial Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B
Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks
Patient population: adults ≥ 20 years who have experienced symptoms of OAB, as defined by International Continence Society (ICS) diagnostic criteria, for at least 3 months
Sample size: approximately 180 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment sequence: randomized with 1:1 ratio to either Sequence A or Sequence B Sequence A: mirabegron 50mg monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> TTNS monotherapy x 8 weeks Sequence B: TTNS monotherapy x 8 weeks -> multi-modal combination treatment x 4 weeks -> mirabegron 50mg monotherapy x 8 weeks
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: mirabegron, Procedure: TTNSmirabegron 50mg OD x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by TTNS twice a week x 8 weeks |
| Sequence B | Experimental | Drug: mirabegron, Procedure: TTNSTTNS twice a week x 8 weeks, followed by mirabegron 50mg OD and TTNS for 4 weeks, followed by mirabegron 50mg OD x 8 weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult OAB patients ≥20 years
- Diagnosed with moderate to severe OAB (with or without urgency incontinence) based on OABSS >5 and clinical assessment, with UUI-predominant presentation, for at least 3 months
- Able to receive TTNS and accommodate treatment logistics (30 min per on-site session, twice weekly)
- Provided informed consent to participate in the study
Key exclusion criteria (14 listed)
- Neurologic conditions associated with OAB symptoms
- History of stress urinary incontinence
- Use of intravesical onabotulinumoxinA within recent 6 months
- Postvoid residual urine volume (PVR) ≥ 100mL
- Evidence of active urinary tract infection or urinary tract stone at screening
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 |
|---|---|---|
| mirabegronmirabegron 50mg QD | Drug | Sequence A, Sequence B |
| TTNStranscutaneous tibial nerve stimulation | Procedure or surgery | Sequence A, Sequence B |
Primary outcome
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS
Time frame: Baseline and Week 20
Changes from baseline to Week 20 in OABSS (Overactive Bladder Symptom Score) (a lower OABSS score represents a better outcome). Symptom improvement is defined as OABSS total score decreased by ≥ 3 points at EoT
21 secondary outcomes
Changes from baseline to Week 12 in OABSS
Time frame: Baseline and Week 12
Changes from baseline to Week 12 and 20/end of treatment (EoT) in IPSS
Time frame: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Micturitions per 24 Hours
Time frame: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Nocturia Episodes per 24 Hours
Time frame: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Episodes per 24 Hours
Time frame: Baseline, and Week 12 and 20
Change from Baseline to Week 12 and 20/end of treatment (EoT) in Mean Number of Urgency Incontinence Episodes per 24 Hours
Time frame: Baseline, and Week 12 and 20
Changes from Week 8 to Week 20 in OABSS
Time frame: Week 8 to Week 20
Changes from Week 8 to Week 20 in IPSS
Time frame: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Micturitions per 24 Hours
Time frame: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
Time frame: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
Time frame: Week 8 to Week 20
Changes from Week 8 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
Time frame: Week 8 to Week 20
Changes from Week 12 to Week 20 in OABSS
Time frame: Week 12 to Week 20
Changes from Week 12 to Week 20 in IPSS
Time frame: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Micturitions per 24 Hours
Time frame: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Nocturia Episodes per 24 Hours
Time frame: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Episodes per 24 Hours
Time frame: Week 12 to Week 20
Changes from Week 12 to Week 20 in Mean Number of Urgency Incontinence Episodes per 24 Hours
Time frame: Week 12 to Week 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Overactive Bladder Questionnaire-Short Form (OAB-Q-SF) score
Time frame: Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Bladder Assessment Tool (BAT) score
Time frame: Baseline, and Week 12 and 20
Changes from baseline to Week 12 and 20/end of treatment (EoT) in Treatment Satisfaction-Visual Analog Scale (TS-VAS) score
Time frame: Baseline, and Week 12 and 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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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.
Chih-Chieh Lin, MD/Phd principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mirabegron and TTNS in people with Overactive Bladder Syndrome, run by Taipei Veterans General Hospital, Taiwan 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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Chieh Lin, MD/Phd (+886-2-2875-7808, jayslylin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline to end of treatment (EoT) (Week 20) in OABSS (time frame: Baseline and Week 20). 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 12 Jan 2022.