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Overactive BladderPhase 4COMFORTNCT01945489

OnabotulinumtoxinA (BOTOX®) Treatment for Urinary Incontinence in Patients With Overactive Bladder

A Phase 4 study testing onabotulinumtoxinA and Normal saline in people with Overactive Bladder, run by Allergan at 40 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overactive Bladder
What is being tested?
onabotulinumtoxinA and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
40 sitesUnited States
Study dates
28 Oct 2013to 5 Jan 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patients with symptoms of Overactive Bladder (OAB) (frequency and urgency) with urinary incontinence for at least 6 months prior to screening.

Who cannot join

  • Symptoms of OAB due to a neurological reason
  • Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening
  • Use of Clean Intermittent Catheterization (CIC) or indwelling catheter to manage urinary incontinence
  • Use of botulinum toxin therapy of any serotype for any urological condition
  • Use of botulinum toxin therapy of any serotype for any non-urological condition in the 12 weeks prior to screening
  • History of any pelvic or urological abnormalities, bladder surgery or disease, other than OAB, that may affect bladder function
  • Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, or Amyotrophic Lateral Sclerosis.

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

United States40 sites

  • Institute of Pelvic Medicine and Reconstructive Surgery

    Allentown, Pennsylvania, 18103

  • Atlanta Medical Research Institute

    Alpharetta, Georgia, 30005

  • Alaska Urological Institute dba Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • U. Colorado, School of Med.

    Aurora, Colorado, 80045

  • Urologic Consultants of Southern Pennsylvania

    Bala-Cynwyd, Pennsylvania, 19004

  • Brooklyn Urology Research Group

    Brooklyn, New York, 11215

  • TriState Urologic Services PSC Inc., dba The Urology Group

    Cincinnati, Ohio, 45212

  • University Hospital Case Medical Center

    Cleveland, Ohio, 44106

  • Genitourinary Surgical Consultants

    Denver, Colorado, 80220

  • Northeast Indiana

    Fort Wayne, Indiana, 46825

  • Accumed Research

    Garden City, New York, 11530

  • Carolina Urology Partners, PLLC

    Gastonia, North Carolina, 28054

  • Urologic Clinics of North Alabama

    Huntsville, Alabama, 35801

  • Urogynecology Associates

    Indianapolis, Indiana, 46202

  • South Orange County Medical Research Center

    Laguna Hills, California, 92653

  • Sunrise Medical Research

    Lauderdale Lakes, Florida, 33319

  • University of Southern California

    Los Angeles, California, 90033

  • Bladder and Prostate Health Investigations, LLC

    Miramar, Florida, 33029

  • Integrity Medical Research, LLC

    Mountlake Terrace, Washington, 98043

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Manhattan Medical Research

    New York, New York, 10016

  • Deaconess Clinic, Inc.

    Newburgh, Indiana, 47630

  • Premier Medical Group of the Hudson Valley

    Newburgh, New York, 12550

  • Urology of Indiana, LLC

    Noblesville, Indiana, 46062

  • Urology Associates of Norwalk

    Norwalk, Connecticut, 06850

  • Renstar Medical Research

    Ocala, Florida, 34471

  • Urology Health Team, PLLC

    Ocala, Florida, 34474

  • Chesapeake Urology Research Associates

    Owings Mills, Maryland, 21117

  • Advanced Urology Centers of NY A division of IMP

    Plainview, New York, 11803

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Associated Urologists of North Carolina

    Raleigh, North Carolina, 27612

  • Virginia Women's Center

    Richmond, Virginia, 23233

  • Virginia Urology

    Richmond, Virginia, 23235

  • Genesis Research LLC

    San Diego, California, 92123

  • The Polyclinic

    Seattle, Washington, 98104

  • Regional Urology, LLC

    Shreveport, Louisiana, 71106

  • Mount Nittany Medical Center Health Services, Inc. dba Mount Nittany Physician Group

    State College, Pennsylvania, 16801

  • Associated Medical Professionals of New York, PLLC

    Syracuse, New York, 13210

  • Southeastern Research Group, Inc.

    Tallahassee, Florida, 32308

  • Urology of Virginia, PLLC

    Virginia Beach, Virginia, 23462

Other trials in United States

About this study

This is a study to evaluate the efficacy and safety of onabotulinumtoxinA (BOTOX®) compared with placebo, in achieving a 100% reduction in urinary incontinence in patients with overactive bladder (OAB) not properly managed with an anticholinergic.

Being tested
onabotulinumtoxinA, Normal saline
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • onabotulinumtoxinABiological

    Also called BOTOX®, botulinum toxin Type A

    OnabotulinumtoxinA (BOTOX®) injected into the detrusor.

  • Normal salineDrug

    Normal saline (placebo) injected into the detrusor.

Study groups in NCT01945489
Study groupRoleWhat they receive
OnabotulinumtoxinAExperimentalOnabotulinumtoxinA (BOTOX®) 100U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Receives: Biological: onabotulinumtoxinA
Placebo/OnabotulinumtoxinAOtherPlacebo (Normal saline) injected into the detrusor on Day 1, followed by an injection of onabotulinumtoxinA 100U after a minimum of 12 weeks (if applicable).
Receives: Biological: onabotulinumtoxinA; Drug: Normal saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes

    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

    Measured: Baseline, Week 12

  2. Change From Baseline in the Daily Average Number of Episodes of Urinary Incontinence

    Urinary incontinence is defined as involuntary loss of urine as recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes were averaged daily during this period. A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

    Measured: Baseline, Week 12

Secondary outcomes (4)

  1. Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores

    The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of participants with urinary incontinence. The questionnaire consists of 7 domains, including emotions, personal relationships, physical limitations, role limitations, severity (coping) measures, sleep/energy and social limitations. Domain scores range from 0 to 100, with a lower score indicating a preferable health status (absence of urinary incontinence impacts). A negative number change from Baseline indicates improvement and a positive number change from Baseline indicates a worsening.

    Measured: Baseline, Week 12

  2. Change From Baseline in the Daily Average Number of Micturition Episodes

    The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of micturition episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

    Measured: Baseline, Week 12

  3. Change From Baseline in the Daily Average Number of Urgency Episodes

    The number of daily urgency episodes (the number of times a patient experiences the urgency to urinate) in Treatment Cycle 1 was recorded by the patient in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of urgency episodes were averaged daily during this period A negative number change from Baseline indicates an improvement and a positive number change from Baseline indicates a worsening.

    Measured: Baseline, Week 12

  4. Change From Baseline in the Daily Average Number of Nocturia Episodes

    Nocturia episodes were recorded by the participant in a bladder diary during the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of nocturia episodes were averaged daily during this period. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from Baseline indicates an improvement and a positive number change from baseline indicates a worsening.

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2013 (estimated)
  2. Study start28 Oct 2013
  3. Primary completion24 May 2016
  4. Study completion5 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945489
Sponsor's protocol ID
GMA-OAB-113
Acronym
COMFORT
Status last verified
Sep 2017
First submitted
16 Sep 2013
Last updated
6 Nov 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • McCammon K, Gousse A, Kohan A, Glazier D, Gruenenfelder J, Bai Z, Patel A, Hale D. Early and Consistent Improvements in Urinary Symptoms and Quality of Life With OnabotulinumtoxinA in Patients With Overactive Bladder and Urinary Incontinence: Results From a Randomized, Placebo-controlled, Phase IV Clinical Trial. Female Pelvic Med Reconstr Surg. 2021 Jul 1;27(7):450-456. doi: 10.1097/SPV.0000000000000914.

    PubMed 32665528

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing onabotulinumtoxinA and Normal saline in people with Overactive Bladder, run by Allergan at 40 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieve a 100% Reduction in Urinary Incontinence Episodes (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01945489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.

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