Randomized Trial for Botox Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Detailed Description
-----------------
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.

Official Title
-----------------
A Randomized Trial of Botox for Severe Urge Incontinence

Conditions
-----------------
Urinary Incontinence

Intervention / Treatment
-----------------
* Other: Bladder diary
* Other: Questionnaires
* Procedure: Urodynamics
* Other: Pad weight


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have ALL of the following: Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit Symptoms of urge incontinence associated with leakage on bladder diary 24-hour pad weight >100 cc's (volume requiring multiple daily diaper changes) Absence of a bladder infection or other condition that could explain urinary leakage Absence of stress incontinence or a cough leak point pressure > 100 cm H2O on cystometry (this correlates with mild stress incontinence) Failed anticholinergic therapy Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox) The ability and willingness to return for surveillance evaluations A negative urine pregnancy test if at risk for pregnancy Competent to give signed consent and complete all of the study measures Exclusion Criteria: Children (< 21 years old), pregnant women and prisoners History of carcinoma of the bladder Absence of a measurable detrusor contraction on a pressure flow micturition study A foreign body in the bladder or other correctable etiology for the UUI Prior documented resistance to Botox Gross fecal incontinence (due to confounding effects on pad weights and counts) Known allergy to lidocaine or related compounds (used for local analgesia) Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis) Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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: 200 units Botox<br>200 units Botulinum-A toxin | Other: Bladder diary<br>* 3-day bladder diary<br>Other: Questionnaires<br>* Incontinence Quality of Life questionnaires<br>Procedure: Urodynamics<br>* Urodynamics<br>Other: Pad weight<br>* Pad weight<br>|
| Experimental: 300 units Botox<br>300 units Botulinum-A toxin | Other: Bladder diary<br>* 3-day bladder diary<br>Other: Questionnaires<br>* Incontinence Quality of Life questionnaires<br>Procedure: Urodynamics<br>* Urodynamics<br>Other: Pad weight<br>* Pad weight<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Bladder diary<br>* 3-day bladder diary<br>Other: Questionnaires<br>* Incontinence Quality of Life questionnaires<br>Procedure: Urodynamics<br>* Urodynamics<br>Other: Pad weight<br>* Pad weight<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes/Day | number of incontinence episodes/day | 9 months |