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

This study has been completed.
Sponsor:
Collaborators:
Novella Clinical, Inc.
Data & Inference, Inc.
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT01125722
First received: May 14, 2010
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Overactive Bladder
Device: Non-invasive neurostimulation device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Change in Mean Daily Urgency Incontinence Episodes [ Time Frame: From baseline to Week 4 of active treatment ] [ Designated as safety issue: No ]
    Mean urgency incontinence episodes (or urinary leaks) over 24 hours is based on a 3-day diary maintained by the subject. Urgency incontinence is when a subject has urinary leakage, i.e., uncontrolled release of fluid prior to making it to the bathroom. The number of leaks over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.


Secondary Outcome Measures:
  • Change in Mean Daily Voiding Frequency [ Time Frame: From baseline to Week 4 of active treatment ] [ Designated as safety issue: No ]
    Mean daily voiding frequency over 24 hours is based on a 3-day diary maintained by the subject. Voiding frequency is defined as the number of times a subject urinates. The number of voids over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.

  • Change in Mean Volume Per Void [ Time Frame: From Baseline to Week 4 of active treatment ] [ Designated as safety issue: No ]
    Mean volume per void (or amount of urine per urination) over 24 hours is based on a 3-day diary maintained by the subject. The volume of void (in milliliters) over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.

  • Change in Mean Urgency Episodes Per Day [ Time Frame: From Baseline to Week 4 of active treatment ] [ Designated as safety issue: No ]
    Mean urgency episodes per day is based on a 3-day diary maintained by the subject. An urgency episode is identified by the subject as a case where they have a strong urge to urinate, i.e. difficulty controlling the bladder and thus are rushing to the bathroom. The number of urgency episodes over 3 days was recorded for each subject at baseline and again at Week 4. The 3-day average at each time point was used as the mean over 24 hours and the change from baseline to Week 4 was calculated for each subject.

  • Change in Mean Overactive Bladder Symptom Composite Score [ Time Frame: From Baseline to Week 4 of active treatment ] [ Designated as safety issue: No ]
    The Overactive Bladder Symptom Composite is a composite symptom score of toilet voids, urgency severity and urge urinary incontinence. It combines the Indevus Urgency Severity Scale for capture of urgency severity per toilet void with 24-hour frequency and urinary urge incontinence episodes. A complete reference for this validated measure can be found in teh Journal of Urology, Vol. 173, pgs 1639-1643, May 2005. The scale is specific to the instrument and lower scores represent an improvement in symptoms. The scale is a weighted average of each void a subject has. The weights are assigned as 0=no urgency, 1=mild, 2=moderate, 3=severe. The minimum score is 0, corresponding to no urgency in every void. There is no quantifiable upper limit since the scale is based on the number of voids per day, but there are reasonable upper limits. For example, if a subject had 15 voids in 1 day and all 15 were severe (=3), the Composite Score would be 45. Full details are in the reference above.


Enrollment: 74
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Investigator Placement Group Device: Non-invasive neurostimulation device
Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator.
Active Comparator: Subject Placement Group Device: Non-invasive neurostimulation device
Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01125722

Locations
United States, District of Columbia
Medical Faculty Associates, The George Washington University
Washington DC, District of Columbia, United States, 20037
United States, Michigan
William Beaumont Hospital - Department of Urology
Royal Oak, Michigan, United States, 48073
United States, New Jersey
AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
Delaware Valley Urology, LLC
Mt Laurel, New Jersey, United States, 08054
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
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Wheaton Franciscan Medical Group, Milwaukee Urogynecology
Wauwatosa, Wisconsin, United States, 53226
Sweden
Danderyd University Hospital
Stockholm, Sweden, 182 88
United Kingdom
Princess Anne Hospital
Southampton, United Kingdom, S016 5YA
Sponsors and Collaborators
Ethicon Endo-Surgery
Novella Clinical, Inc.
Data & Inference, Inc.
Investigators
Principal Investigator: Ashwani Monga, BM BS, MRCOG Princess Anne Hospital, Southampton, UK
  More Information

No publications provided

Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT01125722     History of Changes
Other Study ID Numbers: CI-10-0001
Study First Received: May 14, 2010
Results First Received: April 9, 2012
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on October 23, 2014