At a glance
ClinicalIndex Comparison RecordN/ACompleted· 28 enrolled
Drug / intervention
Bladder diary +3 moreother
Likely dose
Not stated in record
Key inclusion· 7
- ✓Symptoms of urge incontinence with leakage documented on 3-day bladder diary
- ✓24-hour pad weight >100 cc (indicating severe leakage requiring multiple daily diaper changes)
- ✓Failed anticholinergic therapy prior to enrollment
- ✓Able and willing to perform intermittent clean self-catheterization due to risk of urinary retention from Botox
Key exclusion· 10
- ✕Age <21 years, pregnant women, or prisoners
- ✕History of bladder carcinoma
- ✕Absence of measurable detrusor contraction on pressure-flow micturition study
- ✕Foreign body in bladder or other correctable etiology for urge incontinence
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Trial of Botox for Severe Urge Incontinence
In Brief
A clinical study evaluating Bladder diary, Questionnaires, and 2 other interventions for Urinary Incontinence. Completed, enrolled 28 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesUnited States
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionJul 2008
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 20.8 years ago
Interventions
Bladder diaryother
3-day bladder diary
Questionnairesother
Incontinence Quality of Life questionnaires
Urodynamicsprocedure
Urodynamics
Pad weightother
Pad weight