This study will evaluate the efficacy and safety of onabotulinumtoxinA 100 U (BOTOX®), compared to placebo, when injected into the bladder using an alternative injection paradigm in reducing the number of daily urinary incontinence episodes in patients with overactive bladder (OAB) and urinary incontinence whose symptoms have not been adequately managed with an anticholinergic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
OnabotulinumtoxinA (BOTOX®) injection into the bladder.
Placebo (saline) injection into the bladder.
Change From Baseline in Daily Average Number of Urinary Incontinence Episodes
The participant recorded urinary incontinence in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with treatment as a factor at 2 levels, and the number of Urgency Urinary Incontinence (UUI) episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of episodes of incontinence as covariates was used for analyses.
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Percentage of Participants Who Achieved Complete Continence
Complete continence is defined as 100% reduction in urinary incontinence from Baseline.
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12]
Change From Baseline in Daily Average Number of Micturition Episodes
The participant recorded the number of micturition episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of micturition as covariates was used for analyses.
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Urgency Episodes
The participant recorded the number of urgency episode in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of urgency episodes as covariates was used for analyses.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orange County Urology Associates
Laguna Hills, California, United States
Tower Urology
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
East Coast Institute for Research, LLC
Jacksonville, Florida, United States
PMG Research of Christie Clinic
Champaign, Illinois, United States
Deaconess Clinic, Inc.
Evansville, Indiana, United States
Women's Health Advantage
Fort Wayne, Indiana, United States
Urogynecology Associates
Indianapolis, Indiana, United States
Urology of Indiana
Noblesville, Indiana, United States
...and 21 more locations
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12
Change From Baseline in Daily Average Number of Nocturia Episodes
The participants recorded the number of nocturia episodes in a 3-day bladder diary. Data for the three days was averaged. A negative change from Baseline indicates improvement. An ANCOVA model with treatment as a factor at 2 levels, and the number of UUI episodes reported at Baseline (\<= 9 versus \> 9 daily episodes) and Baseline daily average number of nocturia episodes as covariates was used for analyses.
Time frame: Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to, 3 consecutive days prior to Week 12
Percentage of Participants Who Have a Positive Treatment Response on the Treatment Benefit Scale (TBS)
The participant rated their condition during treatment using the TBS 4-point scale where: 1=greatly improved, 2=improved, 3=not changed or 4=worsened. A positive treatment response is either as score of 1=greatly improved or 2=improved.
Time frame: Week 12