BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence

Phase 2

Completed

Conditions: Urinary Incontinence
Overactive Bladder With Urinary Incontinence

Interventions: Drug: OnabotulinumtoxinA and Hydrogel admixture
Drug: Placebo and Hydrogel admixture

Brief Summary: This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.

Recruitment & Eligibility

Inclusion Criteria

Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months
Inadequate response or limiting side effects with pharmacotherapy for the treatment of OAB

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
300U cohort - BOTOX® plus Hydrogel admixture	OnabotulinumtoxinA and Hydrogel admixture	300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
400U cohort - BOTOX® plus Hydrogel admixture	OnabotulinumtoxinA and Hydrogel admixture	400U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
500U cohort - BOTOX® plus Hydrogel admixture	OnabotulinumtoxinA and Hydrogel admixture	500U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
100U cohort - BOTOX® plus Hydrogel admixture	OnabotulinumtoxinA and Hydrogel admixture	100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1
500U cohort - Placebo plus Hydrogel admixture	Placebo and Hydrogel admixture	Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
100U cohort - Placebo plus Hydrogel admixture	Placebo and Hydrogel admixture	Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
400U cohort - Placebo plus Hydrogel admixture	Placebo and Hydrogel admixture	Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1
300U cohort - Placebo plus Hydrogel admixture	Placebo and Hydrogel admixture	Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Primary Outcome Measures

Name	Time	Method
Stage 2: Change From Baseline in the Average Number of Urinary Incontinence Episodes (UIEs) Per Day	Baseline (3 consecutive days during Day -14 to Day -1) to 3 consecutive days in the Week prior to Week 12	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.
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAEs) in the Treatment Period	Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Stage 2: Change From Baseline in the Average Number of Micturition Episodes Per Day	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12	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.
Stage 2: Change From Baseline in the Average Volume Voided Per Micturition	Baseline (3 consecutive days during Days -14 to Day -1) to 3 consecutive days in the Week prior to Week 12	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.

Locations (63): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Coastal Clinical Research, Inc., an AMR company
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Mobile, Alabama, United States
Urological Assoc. of South AZ
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Tucson, Arizona, United States
Hope Clinical Research
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Canoga Park, California, United States
San Bernardino Urological Associates Medical Group
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San Bernardino, California, United States
Wr-McCr, Llc
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San Diego, California, United States
San Diego Clinical Trials
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San Diego, California, United States
Sutter Institute for Medical Health
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Vacaville, California, United States
West Coast Urology
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Whittier, California, United States
The Urology Center of Colorado
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Denver, Colorado, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States