Urinary Incontinence Clinical Trial
Official title:
Therapeutic Efficacy and Safety of Mirabegron , a β3-Adrenoceptor Agonist, Treatment on Patients With Overactive Bladder Syndrome in Taiwan - Predictive Factors for the First Line Use and the Dose Effectiveness Relationship
Verified date | February 2017 |
Source | Buddhist Tzu Chi General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial compared the therapeutic effects and adverse events (AEs) in overactive
bladder (OAB) patients receiving different combination of mirabegron and antimuscarinics.
Methods: This is a prospective randomized study. OAB patients received mirabegron 25 mg
(M25) daily for one month (1M) and then were randomized as group 1: to continue M25, group
2: to mirabegron 50 mg, group 3: to shift to solifenacin 5 mg (S5) and group 4: to combine
M25 and S5 for further 2 months (totally 3 months, 3M). Efficacy and AEs were evaluated. At
the end of 3M, the preferred option for future treatment was investigated.
Status | Completed |
Enrollment | 168 |
Est. completion date | April 27, 2016 |
Est. primary completion date | April 27, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 =1 episode of urgency or urgency incontinence per 24-hours, during a 3-day micturition diary period. 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 stroke, Parkinson's disease, spinal cord injury, multiple sclerosis; 5. Overt bladder outlet obstruction not adequately controlled. 6. Severe medical disease that prohibit patients to undergo clinical investigation. 7. Patient is currently taking medications that might affect lower urinary tract function, such as a1-adrenoreceptor antagonists; medication for diabetes insipidus, antidepressants, 5a reductase inhibitors, capsaicin, resiniferatoxin, or botulinum toxin into the bladder, were also restricted. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Buddhist Tzu Chi General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of urgency or urgency incontinence episode by 2 per day | The percentage of patients in each arm who had reduction of urgency or urgency incontinence episode by 2 per day | from baseline to 12 weeks | |
Secondary | International Prostate Symptom Score total (IPSS-T) | The change of the general bladder symptom score | from baseline to 12 weeks | |
Secondary | quality of life (QoL) index | The change of QoL index | from baseline to 12 weeks | |
Secondary | Overactive Bladder Symptom Score (OABSS) | The change of OABSS | from baseline to 12 weeks | |
Secondary | Urgency Severity Scale (USS) | The change of USS | from baseline to 12 weeks | |
Secondary | Patient's Perception of Bladder Condition (PPBC) | The change of PPBC | from baseline to 12 weeks | |
Secondary | Global Response Assessment (GRA) | The change of GRA | from baseline to 12 weeks | |
Secondary | maximum flow rate (Qmax) | The change of Qmax | from baseline to 12 weeks | |
Secondary | voided volume (Vol) | The change of vol | from baseline to 12 weeks | |
Secondary | Postvoid residual volume m(PVR) | The change of PVR | from baseline to 12 weeks |
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