Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged >Ý 65 years with OAB.

Official Title
-----------------
Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Drug: Darifenacin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of OAB for at least six months prior to Visit 3 Symptoms of OAB during the 7 day diary period immediately preceding Visit 3: ≥ 1 UUIE on average per day and ≥ 10 episodes of micturition on average per day Exclusion Criteria: A total daily urinary volume > 3000 ml or a mean volume voided per micturition of > 300 ml as verified in the micturition diary before randomization Post-void residual (PVR) urinary volume > 100 ml Clinically significant stress urinary incontinence as determined by the investigator Clinically significant bladder outlet obstruction as determined by the investigator Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon. Other protocol inclusion / exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Darifenacin | Drug: Darifenacin<br>* Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily<br>* Other names: Enablex;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo tablet once daily with sham titration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12. |  |  | 
| Safety and tolerability. |  |  | 
| Quality of life at week 6 and/or 12. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population