A Research Study for Patients With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether injections of botulinum toxin Type A into the bladder are safe and effective in treating overactive bladder.

Conditions
-----------------
Overactive Bladder, Urinary Incontinence

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be between 18-85 years old Must have been diagnosed by his/her doctor with overactive bladder at least 6 months ago Must weigh at least 50 kg (110 lbs) Must be willing and able to record information regarding bladder function into a diary (provided) Must be willing and able to complete the entire course of the study Exclusion Criteria: Cannot currently be catheterizing as a way to control incontinence Must not have used botulinum toxin type A or any other botulinum toxin previously for any condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo (normal saline) injected into detrusor on Day 1 | Drug: Placebo<br>* Placebo (normal saline) injected into detrusor on Day 1<br>|
| Experimental: BOTOX 50 U<br>botulinum toxin Type A 50 U injected into detrusor on Day 1 | Biological: botulinum toxin Type A<br>* botulinum toxin Type A injected into detrusor on Day 1<br>* Other names: BOTOX®;|
| Experimental: BOTOX 100 U<br>botulinum toxin Type A 100 U injected into detrusor on Day 1 | Biological: botulinum toxin Type A<br>* botulinum toxin Type A injected into detrusor on Day 1<br>* Other names: BOTOX®;|
| Experimental: BOTOX 150 U<br>botulinum toxin Type A 150 U injected into detrusor on Day 1 | Biological: botulinum toxin Type A<br>* botulinum toxin Type A injected into detrusor on Day 1<br>* Other names: BOTOX®;|
| Experimental: BOTOX 200 U<br>botulinum toxin Type A 200 U injected into detrusor on Day 1 | Biological: botulinum toxin Type A<br>* botulinum toxin Type A injected into detrusor on Day 1<br>* Other names: BOTOX®;|
| Experimental: BOTOX 300 U<br>botulinum toxin Type A 300 U injected into detrusor on Day 1 | Biological: botulinum toxin Type A<br>* botulinum toxin Type A injected into detrusor on Day 1<br>* Other names: BOTOX®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Urinary Urge Incontinence Episodes | Mean number of urinary urge incontinence episodes measured over a 7-day diary prior to week 12. Urinary urge incontinence is defined as urinary leakage associated with a strong desire to urinate. | Baseline, Week 2, Week 6, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Micturitions | Mean number of micturitions measured over a 7 day diary prior to each visit. Micturation is defined as urinating into the toilet. | Baseline, Week 2, Week 6, Week 12 | 
| Change in Number of Nocturia Episodes | Mean number of nocturia episodes measured over a 7 day diary prior to each visit. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. | Baseline, Week 12 | 
| Maximum Cystometric Capacity (MCC) by Urodynamic Measurements | Maximum Cystometric Capacity (maximum volume that the bladder can hold) measured in mean milliliters | Baseline, Week 12 | 
| Incontinence Quality of Life Instrument (I-QOL) | Measured on 3 domains; a 5-point scale (1-5) for each domain. Sum of the domain scores is normalized to a scale of 0-100 (100 = no impact of incontinence on daily activities, 0 = maximum impact of incontinence on daily activities). Mean scores presented. | Baseline, Week 2, Week 6, Week 12 |