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

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)

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Device: Non-invasive neurostimulation device; Device: Non-invasive neurostimulation device

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyd University Hospital
• United Kingdom
  • Southampton, United Kingdom, S016 5YA
    • Princess Anne Hospital
• United States
  • District of Columbia
    • Washington DC, District of Columbia, United States, 20037
      • Medical Faculty Associates, The George Washington University
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital - Department of Urology
  • New Jersey
    • Lawrenceville, New Jersey, United States, 08648
      • AdvanceMed Research
    • Mt Laurel, New Jersey, United States, 08054
      • Delaware Valley Urology, LLC
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • McKay Urology
    • Greensboro, North Carolina, United States, 27403
      • Alliance Urology Specialists, P.A.
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Wisconsin
    • Wauwatosa, Wisconsin, United States, 53226
      • Wheaton Franciscan Medical Group, Milwaukee Urogynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.
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 investigator.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Daily Urgency Incontinence Episodes	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.	From baseline to Week 4 of active treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Daily Voiding Frequency	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.	From baseline to Week 4 of active treatment
Change in Mean Volume Per Void	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.	From Baseline to Week 4 of active treatment
Change in Mean Urgency Episodes Per Day	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.	From Baseline to Week 4 of active treatment
Change in Mean Overactive Bladder Symptom Composite Score	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.	From Baseline to Week 4 of active treatment

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Collaborators: Novella Clinical; Data & Inference, Inc.
• Investigators: Principal Investigator: Ashwani Monga, BM BS, MRCOG, Princess Anne Hospital, Southampton, UK

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: May 14, 2010
• First Submitted That Met QC Criteria: May 17, 2010
• First Posted (ESTIMATE): May 18, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2012
• Last Update Submitted That Met QC Criteria: November 16, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Overactive Bladder; Urinary Incontinence; Urgency; Frequency
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: CI-10-0001