Clinical trial NCT00178191: Randomized Trial for Botox Urinary Incontinence
Official title: A Randomized Trial of Botox for Severe Urge Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2005-09-15
Enrollment: 28
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Episodes/Day
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Michael K Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References: