Urinary Incontinence
Conditions
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.
Interventions
OTHERBladder diary
3-day bladder diary
OTHERQuestionnaires
Incontinence Quality of Life questionnaires
PROCEDUREUrodynamics
Urodynamics
OTHERPad weight
Pad weight
Sponsors
National Institutes of Health (NIH)
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodes/Day | 9 months | number of incontinence episodes/day |
Countries
United States
Participant flow
Recruitment details
Recruitment started June, 2005 and completed Dec, 2007
Participants by arm
| Arm | Count |
|---|---|
| 200 Units Botox 200 units Botulinum-A toxin | 10 |
| 300 Units Botox 300 units Botulinum-A toxin | 11 |
| Placebo Placebo | 7 |
| Total | 28 |
Baseline characteristics
| Characteristic | 300 Units Botox | Placebo | 200 Units Botox | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants | 16.0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 2 Participants | 2 Participants | 12.0 Participants |
| Age Continuous | 61.72 years STANDARD_DEVIATION 13 | 74.14 years STANDARD_DEVIATION 11.01 | 76.20 years STANDARD_DEVIATION 10.65 | 70 years STANDARD_DEVIATION 13.19 |
| Region of Enrollment United States | 11 participants | 7 participants | 10 participants | 28.0 participants |
| Sex: Female, Male Female | 11 Participants | 7 Participants | 10 Participants | 28.0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0.0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 10 | 0 / 7 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 | 0 / 7 |
Outcome results
Primary
Episodes/Day
number of incontinence episodes/day
Time frame: 9 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 200 Units Botox | Episodes/Day | 6.6 number | Standard Error 0.9687 |
| 300 Units Botox | Episodes/Day | 3.52 number | Standard Error 0.95 |
| Placebo | Episodes/Day | 8.7 number | Standard Error 1.52 |