Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03044912
• Date of registration: 03/02/2017
• Prospective Registration: No
• Primary sponsor: Buddhist Tzu Chi General Hospital
• Public title: Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan
• Scientific title: Therapeutic Efficacy and Safety of Mirabegron , a ß3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Comparison of Therapeutic Efficacy and Safety Between 25mg and 50mg
• Date of first enrolment: November 16, 2015
• Target sample size: 574
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03044912
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: Phase 3

Countries of recruitment

Taiwan

Contacts

• Name: Hann-Chorng Kuo, M.D.

• Name: Hann-Chorng Kuo, M.D.

• Name: Hann-Chorng Kuo, M.D.
• Affiliation: Buddhist Tzu Chi General Hospital, Hualien, Taiwan

Key inclusion & exclusion criteria

Inclusion Criteria:

1. symptoms of OAB for at least 12 weeks before initiation of the run-in period;

2. an average of =8 micturitions per 24 hours,

3. an average of =2 episode of urgency or urgency incontinence per 24-hours, during a
3-day micturition diary period.

4. no prior pharmacological treatment for OAB

Exclusion Criteria:

1. stress urinary incontinence as a predominant symptom at screening;

2. urinary tract infection, urinary stone, interstitial cystitis or a history of
recurrent urinary tract infection;

3. confirmed post-void residual (PVR) volume of =100 mL or more or with a clinically
significant lower urinary tract obstructive disease;

4. proven neurogenic bladder such as spinal cord injury, multiple sclerosis;

5. overt bladder outlet obstruction.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Overactive Bladder Syndrome

Intervention(s)

Drug: mirabegron

Primary Outcome(s)

Changes of urgency episodes by 2 per 24 hours [Time Frame: baseline and 3 months]

Secondary Outcome(s)

The net change of mean volume voided per micturition [Time Frame: baseline and 3 months]

Net change of mean number of frequency episodes [Time Frame: baseline and 3 months]

Net change of overactive bladder symptom score (OABSS) [Time Frame: baseline and 3 months]

Net change of the mean number of urgency incontinence episodes [Time Frame: baseline and 3 months]

The net change of mean number of nocturia episodes per 24 hours [Time Frame: baseline and 3 months]

The net change of mean number of urinary incontinence episodes [Time Frame: baseline and 3 months]

Patient Perception on Intensity of Urgency Scale (PPIUS) [Time Frame: baseline and 3 months]

The net change of the Patient Perception of the Bladder Condition (PPBC) [Time Frame: baseline and 3 months]

Secondary ID(s)

TCGHUROL012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors