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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 22
- 主要终点
- Change in Mean Daily Urgency Incontinence Episodes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Mean Daily Urgency Incontinence Episodes
时间窗: 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.
次要结局
- 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)