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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125722

Enrollment

Registered

2010-05-18

Start date

2010-04-30

Completion date

2011-03-31

Last updated

2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Urinary Incontinence, Overactive Bladder, Frequency, Urgency

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.

Interventions

DEVICENon-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Measure	Time frame	Description
Change in Mean Daily Voiding Frequency	From baseline to Week 4 of active treatment	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	From Baseline to Week 4 of active treatment	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	From Baseline to Week 4 of active treatment	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	From Baseline to Week 4 of active treatment	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.

Countries

Sweden, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
Investigator Placement Group Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.	37
Subject Placement Group Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.	37
Total	74

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0
Overall Study	Withdrawal by Subject	2	1

Baseline characteristics

Characteristic	Total	Investigator Placement Group	Subject Placement Group
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	31 Participants	12 Participants	19 Participants
Age, Categorical Between 18 and 65 years	43 Participants	25 Participants	18 Participants
Age Continuous	60.8 years STANDARD_DEVIATION 12.7	59.6 years STANDARD_DEVIATION 10.6	62.1 years STANDARD_DEVIATION 14.6
Region of Enrollment Sweden	13 participants	7 participants	6 participants
Region of Enrollment United Kingdom	8 participants	5 participants	3 participants
Region of Enrollment United States	53 participants	25 participants	28 participants
Sex: Female, Male Female	69 Participants	34 Participants	35 Participants
Sex: Female, Male Male	5 Participants	3 Participants	2 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	16 / 37	14 / 37
serious Total, serious adverse events	0 / 37	0 / 37

Outcome results

Primary

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.

Time frame: From baseline to Week 4 of active treatment