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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Overactive Bladder
- Sponsor
- Ethicon Endo-Surgery
- Enrollment
- 74
- Locations
- 11
- Primary Endpoint
- Change in Mean Daily Urgency Incontinence Episodes
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in Mean Daily Urgency Incontinence Episodes
Time Frame: 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 Outcomes
- Change in Mean Daily Voiding Frequency(From baseline to Week 4 of active treatment)
- Change in Mean Volume Per Void(From Baseline to Week 4 of active treatment)
- Change in Mean Urgency Episodes Per Day(From Baseline to Week 4 of active treatment)
- Change in Mean Overactive Bladder Symptom Composite Score(From Baseline to Week 4 of active treatment)