NCT02024945

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

Evaluation of Health-Related Quality of Life in Patients With Overactive Bladder Syndrome (OAB) Treated With Propiverine, and Its Efficacy and Tolerance in Daily Practice in Belgian General Practitioners and Urologists

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 437 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Overactive Bladder Syndrome

Interventions

Type	Name	Description
DRUG	Propiverine	Propiverine 15 mg tablets or 30 mg regulated release capsules

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2013-12-31
• Last updated: 2013-12-31