Evaluation of an Alternative Injection Paradigm for OnabotulinumtoxinA (BOTOX®) in the Treatment of Overactive Bladder in Patients With Urinary Incontinence

NCT03052764 | Completed Phase 4 Results

• 1 other identifier: CMO-US-URO-0470
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (3 consecutive days during the Screening Period; within 35 days prior to Day 1) to 3 consecutive days prior to Week 12

Secondary Outcomes (5)

• Percentage of Participants Who Achieved Complete Continence

  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

  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

  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

  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)

  Week 12

Study Arms (2)

BOTOX® 100 U/BOTOX® 100 U

ACTIVE COMPARATOR

BOTOX® (onabotulinumtoxinA) 100 U injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Biological: onabotulinumtoxinA

Placebo/BOTOX® 100 U

PLACEBO COMPARATOR

Placebo (saline) injection into the bladder on Day 1 and a second injection BOTOX® 100 U after Week 12 if applicable.

Biological: onabotulinumtoxinA; Drug: Placebo (saline)

Interventions

onabotulinumtoxinA BIOLOGICAL

OnabotulinumtoxinA (BOTOX®) injection into the bladder.

Also known as: BOTOX®, botulinum toxin Type A

BOTOX® 100 U/BOTOX® 100 U; Placebo/BOTOX® 100 U

Placebo (saline) DRUG

Placebo (saline) injection into the bladder.

Placebo/BOTOX® 100 U

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant weighs ≥ 40 kg (88 lb)
• Participant has symptoms of Over Active Bladder (OAB) (frequency and urgency) with urinary incontinence for a period of at least 6 months immediately prior to screening.

You may not qualify if:

• Participant has symptoms of OAB due to any known neurological reason (eg, spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
• Participant has received pharmacologic therapy to treat symptoms of OAB, including nocturia, within 7 days of the start of the screening period procedures
• Participant uses clean intermittent catheterization (CIC) or indwelling catheter to manage urinary incontinence
• Participant has been treated with any intravesical pharmacologic agent (eg, capsaicin, resiniferatoxin) within 12 months of Day 1
• Participant has had previous or current botulinum toxin therapy of any serotype for any urological condition
• Participant has had previous or current botulinum toxin therapy of any serotype for any non-urological condition within 12 weeks of Day 1
• Participant has been immunized for any botulinum toxin serotype
• Participant has history or evidence of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
• Participant has an active genital infection, other than genital warts, either concurrently or within 4 weeks prior to screening
• Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy
• Participant is male with previous or current diagnosis of prostate cancer
• Participant has a history of 2 or more urinary tract infections (UTIs) within 6 months of Day 1 or is taking prophylactic antibiotics to prevent chronic UTIs
• Participant has current or previous uninvestigated hematuria
• Participant has hemophilia, or other clotting factor deficiencies, or disorders that cause bleeding diathesis
• Participant cannot withhold any antiplatelet, anticoagulant therapy or medications with anticoagulant effects for 3 days prior to Day 1

Sponsors & Collaborators

• Allergan: lead

Study Sites (31)

Orange County Urology Associates

Laguna Hills, California, 92653, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Genitourinary Surgical Consultants

Denver, Colorado, 80220, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

PMG Research of Christie Clinic

Champaign, Illinois, 81820, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47113, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Urogynecology Associates

Indianapolis, Indiana, 46062, United States

Location

Urology of Indiana

Noblesville, Indiana, 46062, United States

Location

Iowa Clinic

West Des Moines, Iowa, 50266, United States

Location

Regional Urology

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology

Owings Mills, Maryland, 21117, United States

Location

Beyer Research

Kalamazoo, Michigan, 49009, United States

Location

Michigan Institute of Urology, P.C.

Troy, Michigan, 48084, United States

Location

Adult and Pediatric Urology

Omaha, Nebraska, 68114, United States

Location

Premier Urology LLC

Edison, New Jersey, 08837, United States

Location

Western New York Urology Associates

Cheektowaga, New York, 14225, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Advanced Urology Centers of NY A division of IMP

Plainview, New York, 11803, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12601, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, 27403, United States

Location

Sandhills Medical Center

Hamlet, North Carolina, 28345, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Urologic Consultants of Southeastern Pennsylvania

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Center for Pelvic Health

Franklin, Tennessee, 37067, United States

Location

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

Location

Virginia Urology

Richmond, Virginia, 23230, United States

Location

Virginia Urology Center

Richmond, Virginia, 23235, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Integrity Medical Research, LLC

Mountlake Terrace, Washington, 98043, United States

Location

Related Publications (1)

• Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.

  PMID: 33955921 DERIVED

Related Links

• More Information

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Dana Fetterolf

  Allergan

  STUDY DIRECTOR

• Amin Boroujerdi

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: December 12, 2016
• Primary Completion: December 10, 2018
• Study Completion: December 10, 2018
• Last Updated: December 24, 2019
• Results First Posted: December 24, 2019

Record last verified: 2019-12

Locations

US (31)