Multi-center, Prospective, Randomized, Double-blind, Sham-controlled Clinical Study to Evaluate Safety and Effectiveness of a Transcutaneous, High-frequency, Amplitude-modulated, Non-invasive Neuromodulation Device on Urgency Urinary Incontinence in Subjects With Overactive Bladder (OAB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 28
- 主要终点
- Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
研究概览
简要总结
The purpose of this study is to evaluate the change from baseline between the active and sham treatment groups in the treatment of urgency (urinary) incontinence episodes (leaks).
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
- Double (Participant, Investigator)
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
- •Males and Females, at least 18 years of age
- •Failure on primary OAB treatment, such as behavior modification or fluid/diet management, AND at least one (1) anti-cholinergic drug (unless patient was contra-indicated for anti-cholinergic use)
- •Symptoms of overactive bladder for at least 6 months
- •An average of one (1) or more urgency (urinary) incontinence episodes per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary, with a maximum of 12 urgency (urinary) incontinence episodes per 24-hours
- •Dexterity and ability to place and operate the device
- •Females of child-bearing capability agrees to use a reliable form of birth control for the duration of the trial
- •An average of eight (8) or more voids per 24-hours, over a 3-day period, confirmed by the 3-day baseline voiding diary
- •Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the baseline voiding diary
- •Signed and dated the IRB-approved Informed Consent document.
排除标准
- •Dysfunctional voiding symptoms unrelated to OAB, such as clinically significant bladder outlet obstruction, and urinary retention (pvr > 100 cc)
- •Morbidly obese, defined as having Body Mass Index (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 and uncontrolled 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
- •Any neuromodulation therapy for overactive bladder within the past 3 months
- •Failure to respond to previous neuromodulation therapy for overactive bladder
- •Leading edge of any vaginal prolapse is beyond hymenel ring.
- •Prior peri-urethral or transurethral bulking agent injections for bladder problems within the past 12 months.
- •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.
- •Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.), or any metallic implant in the lower back.
- •Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
- •Known latex allergies, or allergies or hypersensitivity to patch materials that will be in contact with the body (e.g., hydrogel, acrylic-based adhesive, polyurethane).
- •Uncontrolled diabetes and/or diabetes with peripheral neuropathy.
- •Current Urinary Tract Infection (UTI) or history of recurrent UTIs (>3 UTIs in the past year).
- •History of lower tract genitourinary malignancies within the last 6 months or any previous pelvic radiation.
- •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
Evaluate Proportion of Responders Based on the Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
时间窗: 12 weeks (Randomized Phase) and 12 Months (Open Label)
The primary objective of the randomized phase of the study is to evaluate the 12 week change from baseline in mean urgency (urinary) incontinence episodes (leaks) between the active and sham treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). The primary objective of the open label phase of the study is to evaluate and confirm the continued efficacy of the VERV™ System for long-term use. The primary objective was assessed with rate of responders, where responder was defined as a subject who achieved a decrease of ≥50% in mean urgency urinary incontinence episodes at 12 weeks compared to baseline.
Evaluate the Median Change From Baseline in Mean Urgency (Urinary) Incontinence Episodes (Leaks) Between the Active and Sham Treatment Groups
时间窗: 12 weeks (Randomized Phase) and 12 Months (Open Label)
The primary objective of the randomized phase of the study is to evaluate the 12 week and 12 month median change from baseline in mean urgency (urinary) incontinence episodes (leaks) between treatment groups. The mean of the number of urinary incontinence episodes over 24 hours" is defined as the mean of the number of UIEs recorded per 24 hour period for three consecutive days (via a 3-day diary). Mean urinary frequency episodes calculated for each patient during time period. The median change in frequency was then calculated for each treatment group. Distribution of changes from baseline were then assessed prospectively for normality using the Kolmogorov - Smirnoff test. Since departure from normality was actually observed in the distribution, the Wilcoxon Rank-Sum test was performed to compare the median change between treatment groups and the p-values for the test of equality of medians were reported along with the medians.
次要结局
- Measure Decrease in the Median Change From Baseline in Mean Urgency Episodes(12 weeks)
- Measure Improvement in the Median of the Mean OAB-Symptom Composite Score(12 weeks)
- Change in Patient Perception of Bladder Condition (PPBC) From Baseline (Screening Period) to Week 12 as Defined as an Improvement in Severity.(12 Weeks (Randomized Phase) and 12 Months (Open Label Phase))
- Assessment of Improvement as Measure by Overactive Bladder Satisfaction With Treatment Questionnaire (OAB-SAT)(12 weeks)
- Assessment of Treatment Benefit Scale (TBS)(12 Weeks)
- Measure Change in the Median of the Mean Urinary Frequency(12 weeks and 12 Months)
- Measure Median Change in Mean Volume Per Void(12 weeks)
- Change in Median Total Health Related Quality of Life (HRQL) of OAB-q From Baseline (Screening) to Week 12(12 Weeks (Randomized Phase) and 12 Months (Open Label).)
- Change Clinical Global Impressions at 12 Weeks(12 weeks (Randomized Phase) and 12 Months (Open Label Phase))