This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
383
BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
Placebo and Hydrogel admixture administered as a single intravesical instillation
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day
The participant recorded urinary incontinence (lack of voluntary control over urination) in a 3-day bladder diary. The average number of UIEs per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. An analysis of covariance (ANCOVA) model was used for analyses.
Time frame: Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period
An adverse event (AE) is any untoward medical occurrence in a participants or clinical study investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. A TEAE is an AE that occurs or worsens after receiving study drug.
Time frame: Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day
The participant recorded the number of micturition (urination in toilet or catherization) episodes per day in a 3-day bladder diary. The average number of micturition episodes per day is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.
Time frame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Coastal Clinical Research, Inc., an AMR company
Mobile, Alabama, United States
Urological Assoc. of South AZ
Tucson, Arizona, United States
Hope Clinical Research
Canoga Park, California, United States
San Bernardino Urological Associates Medical Group
San Bernardino, California, United States
Wr-McCr, Llc
San Diego, California, United States
San Diego Clinical Trials
San Diego, California, United States
Sutter Institute for Medical Health
Vacaville, California, United States
West Coast Urology
Whittier, California, United States
The Urology Center of Colorado
Denver, Colorado, United States
...and 53 more locations
Volume voided per micturition was recorded over one 24-hour period during the 3-day bladder diary. The volume voided during each 24-hour period was divided by the number of micturitions during the period. The average volume voided per micturition is the average of the 3-day diary entries. A negative change from Baseline indicates improvement. Baseline is defined as the last non-missing assessment before the first dose of study treatment. ANCOVA model was used for analyses.
Time frame: Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12