Switch from Beta-3 to Beta-3 Therapy for Overactive Bladder Symptoms Study

JRCT ID: jRCT1031190024

Registered date:20/05/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Overactive bladder
• Date of first enrollment: 24/06/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Switch from Beta-3 to Beta-3 Therapy for Residual Overactive Bladder Symptoms and evaluate the efficacy and safety.

Outcome(s)

• Primary Outcome: The change of OABSS score

Secondary Outcome

1)Change in OABSS subscores(4 element)
2)Change in IPSS total score
3)Change in IPSS subscores(3 element and 7 element)
4)Change in IPSS-QOL score
5) Changes in the items tabulated from the voiding diary (No. of voids, urinary urgency, pressure incontinence, No. of nocturnal voiding, volume /void) and proportion of normalized subjects in these symptoms
6) Proportion of subjects with highly improved / improved in PGI assessment
7) Proportion of subjects with minimum score changes in OABSS total score
8) Correlation of OABSS subsocres and PGI

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Has a diagnosis of OAB
2) Aged 40 years or older
3) Has remaining symptoms (OABSS total score >= 3 and urinary urgency >= 2) after mirabegron treatment for 8 weeks or more
4) IPSS-QOL score >= 4
5) Able to urinate without assistance
6) Able to record voiding diary data
7) Provided written informed consent

Exclude criteria

1) Has only stress urinary incontinence
2) Post-void residual >= 100ml
3) Has a complication with similar symptoms to OAB except for prostatic hyperplasia
4) Has a malignancy
5) Has a scheduled surgical treatment for OAB or BPH during the study period
6) Has a hypersensitivity to Beta-3 agonists
7) Has previously administered vibegron
8) Considered inappropriate for participating in the study by the investigator.

Related Information

• Primary Sponsor: Kato Shinobu
• Source(s) of Monetary Support: KISSEI PHARMACEUTICAL CO.,LTD