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

May 24, 2011
June 19, 2012
June 2011
July 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01369485 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Effectiveness of a Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Overactive Bladder
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)

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Overactive Bladder
  • 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
  • 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
  • Active Comparator: Active Treatment group
    Intervention: Device: (VERV™ System)
  • Sham Comparator: Sham Treatment Group
    Intervention: Device: Sham version of (VERV™ System)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
July 2013
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01369485
CI-10-0009
No
Ethicon Endo-Surgery
Ethicon Endo-Surgery
  • Novella Clinical, Inc.
  • Data & Inference, Inc.
Principal Investigator: Michael Kennelly, MD McKay Urology
Ethicon Endo-Surgery
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP