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

Ethicon

Status

Completed

Conditions

Overactive Bladder

Treatments

Device: Non-invasive neurostimulation device

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01125722

CI-10-0001

Details and patient eligibility

About

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.

Full description

While the precise cause of OAB symptoms (urge, frequency, incontinence) is not clear, most physicians and researchers accept the theory that a problem in the communication between the central nervous system and the bladder is a factor.

Research has shown that a process called neuromodulation of the nerves controlling the bladder can overcome this communication problem. In patients who have symptoms caused by the communication problem, neuromodulation has been clinically proven to eliminate or significantly reduce those symptoms. While neuromodulation has been previously achieved by implanting an electrode near the sacral nerve in the spine, the new concept under investigation within this protocol is believed to achieve a similar effect from adhesive electrodes placed on the skin over spinal nerves in the lower back.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
Transurethral instrumentation within the preceding month.
Scheduled for any of the following during the course of the study: Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), X-ray, Ultrasound, or Radiotherapy (targeting full body or back region)
Recurrent Urinary Tract Infections (>3 UTI's in the past year)
Clean catch Urinalysis results >10wbc/hpf
History of or current lower tract genitourinary malignancies
Any clinically significant systemic disease or condition that in the opinion of the Investigator would make the patient unsuitable for the study