Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder

Novartis

Status and phase: Completed; Phase 4

Conditions: Urinary Incontinence

Treatments: Drug: Darifenacin; Behavioral: Behavioral therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00127270

CDAR328AUS01

Details and patient eligibility

About

This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.

Enrollment: 395 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptoms of overactive bladder
• Capable of independent toileting and completing a micturition diary
• Able to comprehend English and follow study procedures and instructions

Exclusion criteria

• Post void residual > 100ml/sec
• Urine flow rate (Qmax) <10ml/sec for males only

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

395 participants in 2 patient groups

1

Experimental group

Description:

Darifenacin

Treatment:

Drug: Darifenacin

Drug: Darifenacin

2

Other group

Description:

Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder

Treatment:

Drug: Darifenacin

Drug: Darifenacin

Behavioral: Behavioral therapy