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

Astellas

Status

Completed

Conditions

Overactive Bladder (OAB)

Treatments

Drug: tolterodine

Drug: fesoterodine

Drug: imidafenacin

Device: propiverine

Device: solifenacin

Drug: darifenacin

Drug: trospium

Drug: oxybutynin

Drug: mirabegron

Study type

Observational

Funder types

Industry

Identifiers

NCT03572231

178-MA-3146

Details and patient eligibility

About

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.

Full 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.

Enrollment

805 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with OAB symptoms (with or without urgency incontinence) with symptoms for at least three months prior to study enrollment.
About to initiate monotherapy of mirabegron or any antimuscarinics therapy for OAB symptoms, prescribed as part of routine clinical practice, which maybe the first course of any treatment for OAB, lapsed of treatment, or switching from one drug to another.

Exclusion criteria

Currently receiving more than one medication (including Chinese herbal medicine) for OAB.
Current participation in clinical trials of OAB.
Have undergone surgery for OAB in the past.
Mixed incontinence where stress incontinence is the predominant form.
OAB has been treated with onabotulinum toxin A, sacral neuromodulation, percutaneous tibial nerve stimulation, external beam radiation (XRT), stents, surgery, or intermittent catheterization prior to or at time of enrollment.
At risk of Acute Urinary Retention (AUR).
Neurologic conditions associated with OAB symptoms.
Hypersensitivity and contraindication(s) to mirabegron and antimuscarinics.

Trial design

805 participants in 2 patient groups

mirabegron

Description:

Participants will commence the OAB treatment with mirabegron that is prescribed by a physician in routine clinical practice.

Treatment: