Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder
Summary
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Overactive Bladder (OAB)
Intervention
Darifenacin
Location
Investigative Site
Birmingham
Alabama
United States
35242
Status
Completed
Source
Novartis
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00366002
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Urinary Bladder, Overactive
Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.
Cystocele
A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.
Urinary Incontinence, Stress
Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.
Urinary Bladder Fistula
An abnormal passage in the URINARY BLADDER or between the bladder and any surrounding organ.
Urinary Bladder Neck Obstruction
Blocked urine flow through the bladder neck, the narrow internal urethral opening at the base of the URINARY BLADDER. Narrowing or strictures of the URETHRA can be congenital or acquired. It is often observed in males with enlarged PROSTATE glands.
Clinical Trials
Patient perspective on Overactive Bladder and symptoms experienced after administration of Darifenacin
Using Behavioral Therapy in Combination With Darifenacin for Symptoms of Overactive Bladder
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 therapie...
This study will assess the efficacy of a 12-week treatment with darifenacin in increasing warning time, the time from first sensation of urgency to voiding, in patients with OAB.
This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.
Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness
The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic ca...
PubMed Articles
Time-to-effect with darifenacin in overactive bladder: a pooled analysis.
INTRODUCTION AND HYPOTHESIS: This study was conducted to assess time-to-effect with darifenacin in patients with overactive bladder (OAB)....
INTRODUCTION: Patient-reported outcome (PRO) instruments are useful for assessing treatment success in patients with overactive bladder (OAB). PROs such as the OAB Questionnaire (OAB-q) and Patient Pe...
The blockade of muscarinic receptors in the management of overactive bladder (OAB) symptoms provides beneficial as well as adverse effects. The cognitive changes observed are caused by the drugs' abil...
Urogynecology, overactive bladder, and neurourology.
This overview presents new results regarding urogynecology, overactive bladder, and neurourology. The importance of interdisciplinary pelvic floor centers and Burch colposuspension are discussed.
β3-Receptor Agonists for Overactive Bladder-New Frontier or More of the Same?
The new information generated over the last decade on the physiology/pharmacology of the normal bladder and on the pathophysiology of the overactive bladder has resulted in the introduction of a new t...