Clinical trial NCT01125722: Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
Official title: Pilot Clinical Trial to Study the Effectiveness of a Four-week Exposure to a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence in Subjects With Idiopathic Overactive Bladder (OAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Keywords: Urinary Incontinence
Overactive Bladder
Frequency
Urgency
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
Collaborators: name: Novella Clinical
name: Data & Inference, Inc.
First posted: 2010-05-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Mean Daily Urgency Incontinence Episodes
timeFrame: From baseline to Week 4 of active treatment
Secondary outcomes:
measure: Change in Mean Daily Voiding Frequency
timeFrame: From baseline to Week 4 of active treatment
measure: Change in Mean Volume Per Void
timeFrame: From Baseline to Week 4 of active treatment
measure: Change in Mean Urgency Episodes Per Day
timeFrame: From Baseline to Week 4 of active treatment
measure: Change in Mean Overactive Bladder Symptom Composite Score
timeFrame: From Baseline to Week 4 of active treatment
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Medical Faculty Associates, The George Washington University
state: District of Columbia
city: Royal Oak
country: United States
facility: William Beaumont Hospital - Department of Urology
state: Michigan
city: Lawrenceville
country: United States
facility: AdvanceMed Research
state: New Jersey
city: Mt Laurel
country: United States
facility: Delaware Valley Urology, LLC
state: New Jersey
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists, P.A.
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Wauwatosa
country: United States
facility: Wheaton Franciscan Medical Group, Milwaukee Urogynecology
state: Wisconsin
city: Stockholm
country: Sweden
facility: Danderyd University Hospital
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital
Study officials:
affiliation: Princess Anne Hospital, Southampton, UK
name: Ashwani Monga, BM BS, MRCOG
role: PRINCIPAL_INVESTIGATOR
References: