Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)

Completed · Not applicable

Conditions studied: Overactive Bladder

In brief

The purpose of this study is to determine whether the non-invasive neurostimulation patch is effective in the treatment of urgency, frequency and urge (urinary) incontinence.

Key facts

Study ID

NCT01125722

Run by

Ethicon Endo-Surgery

People needed

74

Starts

2010-04-01

Expected to finish

2011-03-01

Last updated by the study team

2012-12-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Potential subjects must satisfy the following criteria in order to be enrolled in the study:
• Males and Females, at least 18 years of age
• Documented symptoms of idiopathic overactive bladder for at least 6 months
• Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug
• An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
• An average of eight (8) or more voids per 24-hours, confirmed by the 3-day baseline voiding diary
• Demonstrated ability to adequately complete the 3-day baseline voiding diary
• Willing and capable of understanding and complying with all requirements of the protocol
• Signed Informed Consent to participate in the study after full discussion of the research nature of the treatment and its risks and benefits.

You may not qualify if…

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Urinary retention
• Clinically significant bladder outlet obstruction
• Morbidly obese, defined as having 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.
• History of 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
• Failure of previous neuromodulation therapy for overactive bladder
• Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
• Any clinically significant congenital or acquired disorder of the urogenital tract (including denovo OAB following sub-urethral sling)
• Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ Prolapse Quantification (POPQ) criteria.
• Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
• History of pelvic radiation therapy
• 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.
• Unable to operate the device remote control.
• Lacking dexterity to properly utilize the components of the device system.
• Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
• Any metallic implant in the back.
• Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
• History of dementia or Alzheimer's disease.
• Known latex allergies
• Uncontrolled diabetes and/or diabetes with peripheral neuropathy.

Where it is running

• Medical Faculty Associates, The George Washington University — Washington D.C., District of Columbia, United States
• William Beaumont Hospital - Department of Urology — Royal Oak, Michigan, United States
• AdvanceMed Research — Lawrenceville, New Jersey, United States
• Delaware Valley Urology, LLC — Mount Laurel, New Jersey, United States
• McKay Urology — Charlotte, North Carolina, United States
• Alliance Urology Specialists, P.A. — Greensboro, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Wheaton Franciscan Medical Group, Milwaukee Urogynecology — Wauwatosa, Wisconsin, United States
• Danderyd University Hospital — Stockholm, Sweden
• Princess Anne Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.