Efficacy, Tolerability and Impact on Quality of Life of Propiverine in Patients With Overactive Bladder Syndrome

Takeda

Status

Completed

Conditions

Overactive Bladder Syndrome

Treatments

Drug: Propiverine

Study type

Observational

Funder types

Industry

Identifiers

NCT02024945

MN-9999-401-BE

U1111-1146-5884 (Other Identifier)

Details and patient eligibility

About

The purposes of this study were to assess Quality of Life (QoL) and urination urge, incontinence, and micturition frequency including nocturia after 4 and 12 weeks treatment with propiverine.

Full description

The drug being tested in this study is called propiverine. Propiverine is being tested to evaluate Quality of Life (QoL) and improvement of OAB symptoms in people who take propiverine. The study will enroll approximately 1000 patients who the treating physician decided to treat with propiverine 15mg tablets or 30 mg regulated release capsules as part of their normal clinical practice. All participants will be asked to keep a voiding diary for 2 consecutive days and to complete a QoL questionnaire after 1st visit and before each subsequent visit. This multi-centre trial will be conducted in Belgium. The overall time to participate in this study is up to 12 weeks. Participants will make 3 visits to their healthcare provider.

Enrollment

437 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Written informed consent. 2. At least 18 years of age. 3. Patients with complaints of Overactive Bladder Syndrome (OAB) without urge incontinence, OAB with urge incontinence, or with mixed urinary incontinence. 4. Patients who consult their GP or an urologist for the first time with these complaints or who stopped their OAB treatment since at least one month. 5. Receiving a propiverine prescription according to the Summary of Product Characteristics (SPC).

Exclusion criteria