Back to resultsClinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Non-invasive neurostimulation device
Non-invasive neurostimulation device
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring Urinary Incontinence, Overactive Bladder, Frequency, Urgency
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
Sites / Locations
- Medical Faculty Associates, The George Washington University
- William Beaumont Hospital - Department of Urology
- AdvanceMed Research
- Delaware Valley Urology, LLC
- McKay Urology
- Alliance Urology Specialists, P.A.
- Medical University of South Carolina
- Vanderbilt University Medical Center
- Wheaton Franciscan Medical Group, Milwaukee Urogynecology
- Danderyd University Hospital
- Princess Anne Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Investigator Placement Group
Subject Placement Group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT01125722
First Posted
May 14, 2010
Last Updated
November 16, 2012
Sponsor
Ethicon Endo-Surgery
Collaborators
Novella Clinical, Data & Inference, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01125722
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon Endo-Surgery
Collaborators
Novella Clinical, Data & Inference, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Urinary Incontinence, Overactive Bladder, Frequency, Urgency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigator Placement Group
Arm Type
Active Comparator
Arm Title
Subject Placement Group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Non-invasive neurostimulation device
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Non-invasive neurostimulation device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Mean Daily Urgency Incontinence Episodes
Description
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.
Time Frame
From baseline to Week 4 of active treatment
Secondary Outcome Measure Information:
Title
Change in Mean Daily Voiding Frequency
Description
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.
Time Frame
From baseline to Week 4 of active treatment
Title
Change in Mean Volume Per Void
Description
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.
Time Frame
From Baseline to Week 4 of active treatment
Title
Change in Mean Urgency Episodes Per Day
Description
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.
Time Frame
From Baseline to Week 4 of active treatment
Title
Change in Mean Overactive Bladder Symptom Composite Score
Description
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.
Time Frame
From Baseline to Week 4 of active treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwani Monga, BM BS, MRCOG
Organizational Affiliation
Princess Anne Hospital, Southampton, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Faculty Associates, The George Washington University
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
William Beaumont Hospital - Department of Urology
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Delaware Valley Urology, LLC
City
Mt Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Alliance Urology Specialists, P.A.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Wheaton Franciscan Medical Group, Milwaukee Urogynecology
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Danderyd University Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Princess Anne Hospital
City
Southampton
ZIP/Postal Code
S016 5YA
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Study a Non-invasive Neurostimulation Device on Urgency (Urinary) Incontinence Overactive Bladder (OAB)
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