Loading search results

Outcome Measures

Primary Outcomes (2)

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.
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.
Up to End of Study (Stage 1: Up to 114 days and Stage 2: Up to 35.1 weeks)

Secondary Outcomes (2)

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
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

Study Arms (8)

100U cohort - BOTOX® plus Hydrogel admixture

EXPERIMENTAL

100U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Drug: OnabotulinumtoxinA and Hydrogel admixture

100U cohort - Placebo plus Hydrogel admixture

PLACEBO COMPARATOR

Placebo and Hydrogel admixture administered as a single intravesical instillation on Day 1

Drug: Placebo and Hydrogel admixture

300U cohort - BOTOX® plus Hydrogel admixture

EXPERIMENTAL

300U BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation on Day 1

Interventions

OnabotulinumtoxinA and Hydrogel admixtureDrug

BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation

Also known as: BOTOX®, Botulinum Toxin Type A

100U cohort - BOTOX® plus Hydrogel admixture300U cohort - BOTOX® plus Hydrogel admixture400U cohort - BOTOX® plus Hydrogel admixture500U cohort - BOTOX® plus Hydrogel admixture

Placebo and Hydrogel admixture

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Study Sites (63)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Coastal Clinical Research, Inc., an AMR company

Mobile, Alabama, 36608, United States

Urological Assoc. of South AZ

Tucson, Arizona, 85715, United States

Hope Clinical Research

Canoga Park, California, 91303, United States

San Bernardino Urological Associates Medical Group

San Bernardino, California, 92404, United States

Wr-McCr, Llc

San Diego, California, 92108, United States

San Diego Clinical Trials

San Diego, California, 92120, United States

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (8)

100U cohort - BOTOX® plus Hydrogel admixture

100U cohort - Placebo plus Hydrogel admixture

300U cohort - BOTOX® plus Hydrogel admixture

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (63)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

300U cohort - Placebo plus Hydrogel admixture

400U cohort - BOTOX® plus Hydrogel admixture

400U cohort - Placebo plus Hydrogel admixture

500U cohort - BOTOX® plus Hydrogel admixture

500U cohort - Placebo plus Hydrogel admixture

Data Sharing

Source record

Documents

Locations