Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder (Beacon)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Ethicon Endo-Surgery.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Novella Clinical, Inc.
Data & Inference, Inc.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01369485
First received: May 24, 2011
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).


Condition Intervention
Overactive Bladder
Device: (VERV™ System)
Device: Sham version of (VERV™ System)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Evaluate the change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The primary objective of this study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups


Secondary Outcome Measures:
  • Measure decrease in mean urinary frequency [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the 12 week change from baseline in decrease of mean urinary frequency between the active and sham treatment groups

  • Measure increase in mean volume per void [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the 12 week change from baseline in mean volume per void between the active and sham treatment groups

  • Measure decrease in mean urgency episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the 12 week change from baseline in mean urgency episodes between the active and sham treatment groups

  • Measure improvement in mean OAB-Symptom Composite score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluate the 12 week change from baseline improvement in mean OAB-Symptom Composite score between the active and sham treatment groups


Estimated Enrollment: 160
Study Start Date: June 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Treatment group Device: (VERV™ System)
Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Other Name: Non-invasive neurostimulation device
Sham Comparator: Sham Treatment Group Device: Sham version of (VERV™ System)
Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
Other Name: Inactive Non-invasive neurostimulation device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and Females, at least 18 years of age
  • Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use)
  • Symptoms of overactive bladder for at least 6 months
  • An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
  • Dexterity and ability to place and operate the device
  • Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial
  • An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary
  • Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary
  • Signed and dated the IRB-approved Informed Consent document.

Exclusion Criteria:

  • Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc)
  • Morbidly obese, defined as having Body Mass Index (BMI) > 40 kg/m2
  • Stress predominant mixed urinary incontinence
  • Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and uncontrolled epilepsy.
  • Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
  • Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 12 months
  • Any neuromodulation therapy for overactive bladder within the past 3 months
  • Failure to respond to previous neuromodulation therapy for overactive bladder
  • Leading edge of any vaginal prolapse is beyond hymenel ring.
  • Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
  • Any skin conditions affecting treatment or assessment of the treatment sites
  • History of lower back surgery or injury that could impact placement of the patch, or where underlying scar tissue or nerve damage may impact treatment.
  • Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back.
  • Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
  • Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane).
  • Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
  • Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year).
  • History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation.
  • Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369485

Locations
United States, Arizona
Arizona Urologic Specialists
Tucson, Arizona, United States, 85712-5803
United States, California
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562
United States, District of Columbia
GW Medical Faculty Associates
Washington, District of Columbia, United States, 20037
United States, Florida
Specialists in Urology
Naples, Florida, United States, 34102
Urology Center of Florida
Pompano Beach, Florida, United States, 33060
United States, Illinois
Women's Health Institute of Illlinois, Ltd
Oak Lawn, Illinois, United States, 60453
United States, Indiana
1st Urology, PSC dba Metropolitan Urology
Jeffersonville, Indiana, United States, 47130
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New York
University Urology Associates
New York, New York, United States, 10016
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States, 28207
Alliance Urology Specialists, P.A.
Greensboro, North Carolina, United States, 27403
United States, South Carolina
Carolina Urologic Research
Myrtle Beach, South Carolina, United States, 29572
United States, Washington
Integrity Medical Research
Mountlake Terrace, Washington, United States, 98043
United States, Wisconsin
Wheaton Franciscan Medical Group - Milwaukee Urogynecology
Wauwatosa, Wisconsin, United States, 53226
Sponsors and Collaborators
Ethicon Endo-Surgery
Novella Clinical, Inc.
Data & Inference, Inc.
Investigators
Principal Investigator: Michael Kennelly, MD McKay Urology
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01369485     History of Changes
Other Study ID Numbers: CI-10-0009
Study First Received: May 24, 2011
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ethicon Endo-Surgery:
Urinary Incontinence
Overactive Bladder
Frequency
Urgency

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on August 20, 2014