Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan

NCT03059134 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: BuddhistTCGH
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Incontinence; Overactive Bladder Syndrome

Keywords

Overactive bladder; Pharmacotherapy; Adverse event

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• International Prostate Symptom Score total (IPSS-T)

  from baseline to 12 weeks

• quality of life (QoL) index

  from baseline to 12 weeks

• Overactive Bladder Symptom Score (OABSS)

  from baseline to 12 weeks

• Urgency Severity Scale (USS)

  from baseline to 12 weeks

• Patient's Perception of Bladder Condition (PPBC)

  from baseline to 12 weeks

Study Arms (4)

Mirabegron 25mg for 12 weeks

EXPERIMENTAL

Mirabegron 25mg once-daily for 4 weeks, and continue the same dose of mirabegron for another 8 weeks

Drug: Mirabegron 25mg

Mirabegron 25mg followed by 50mg

ACTIVE COMPARATOR

Mirabegron 25mg once-daily for 4 weeks, and increase the dose to 50mg for another 8 weeks

Drug: Mirabegron 25mg

Mirabegron 25mg followed by solifenacin

ACTIVE COMPARATOR

Mirabegron 25mg once-daily for 4 weeks, and shift to solifenacin 5mg for another 8 weeks

Drug: Mirabegron 25mg

Mirabegron 25mg add-on solifenacin

ACTIVE COMPARATOR

Mirabegron 25mg once-daily for 4 weeks, and add-on solifenacin 5mg for another 8 weeks,

Drug: Mirabegron 25mg

Interventions

Mirabegron 25mg DRUG

We compared the therapeutic effects and adverse events (AEs) in overactive bladder (OAB) patients receiving different combination of mirabegron and solifenacin.

Also known as: Betmiga

Mirabegron 25mg add-on solifenacin; Mirabegron 25mg followed by 50mg; Mirabegron 25mg followed by solifenacin; Mirabegron 25mg for 12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of OAB for at least 12 weeks before initiation of the run-in period;
• An average of ≥8 micturitions per 24 hours,
• An average of ≥1 episode of urgency or urgency incontinence per 24-hours, during a 3-day micturition diary period.

You may not qualify if:

• Stress urinary incontinence as a predominant symptom at screening;
• Urinary tract infection, urinary stone, interstitial cystitis or a history of recurrent urinary tract infection;
• Confirmed post-void residual (PVR) volume of ≥100 mL or more or with a clinically significant lower urinary tract obstructive disease;
• Proven neurogenic bladder such as stroke, Parkinson's disease, spinal cord injury, multiple sclerosis;
• Overt bladder outlet obstruction not adequately controlled.
• Severe medical disease that prohibit patients to undergo clinical investigation.
• Patient is currently taking medications that might affect lower urinary tract function, such as α1-adrenoreceptor antagonists; medication for diabetes insipidus, antidepressants, 5α reductase inhibitors, capsaicin, resiniferatoxin, or botulinum toxin into the bladder, were also restricted.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive

Interventions

mirabegron

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Officials

• Hann-Chorng Kuo, MD

  Department of Urology, Buddhist Tzu Chi General Hospital, Hualien, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Department of Urology

Model Details: The study population consisted of male and female outpatients meeting the legal minimum age requirement of the region with symptoms of OAB for more than 3 months. Patient demographics data will be recorded as detailed as possible, including previous urodynamic study results. The study consisted of four arms: 1. Mirabegron 25mg once-daily for 4 weeks, and continue the same dose of mirabegron for another 8 weeks 2. Mirabegron 25mg once-daily for 4 weeks, and increase the dose to 50mg for another 8 weeks 3. Mirabegron 25mg once-daily for 4 weeks, and shift to solifenacin 5mg for another 8 weeks 4. Mirabegron 25mg once-daily for 4 weeks, and add-on solifenacin 5mg for another 8 weeks,

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 23, 2017
• Study Start: April 28, 2015
• Primary Completion: April 27, 2016
• Study Completion: April 27, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share