NCT03572231

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

A Prospective, Non-interventional, Registry Study of Patients Initiating Pharmacologic Therapy for Overactive Bladder in Taiwan, Korea and China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 805 (actual)
• Sponsor: Astellas Pharma Singapore Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and describe treatment patterns, like Overactive Bladder (OAB) treatment discontinuation, switching to other therapies and persistence of OAB therapies in routine clinical practice. This study will also evaluate effectiveness of OAB therapies in routine clinical practice; identify factors associated with effectiveness and persistence of pharmacologic therapies in OAB participants; evaluate the Quality of Life (QoL) and treatment satisfaction of OAB therapies; as well as evaluate health care resource utilization (HCRU) and understand adverse events (AEs), serious adverse events (SAEs) and adverse drug reactions (ADRs) associated with OAB therapies.

Detailed description

This is an observational registry study and will not provide or recommend any treatment; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with the treating physician's usual practices and all eligible participants will be enrolled in a certain timeframe. OAB participants enrolled in the study will be categorized into one of two treatment groups, but the study does not plan to compare the two treatment groups.

Conditions

• Overactive Bladder (OAB)

Interventions

Type	Name	Description
DRUG	mirabegron	oral
DEVICE	solifenacin	oral
DRUG	darifenacin	oral
DRUG	imidafenacin	oral
DRUG	tolterodine	oral
DRUG	oxybutynin	oral
DRUG	trospium	oral
DRUG	fesoterodine	oral
DEVICE	propiverine	oral

Timeline

• Start date: 2018-07-19
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2018-06-28
• Last updated: 2020-04-22

Locations

15 sites across 2 countries: South Korea, Taiwan