NCT01783392已完成不适用
Peripheral Electrical Stimulation for the Treatment of Overactive Bladder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change in Patient Perception of Bladder Condition (PPBC)
研究概览
简要总结
This clinical trial testing three different sites of transcutaneous electrical nerve stimulation for the treatment of overactive bladder (OAB).
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
- •Males and Females, at least 18 years of age
- •Documented symptoms of idiopathic overactive bladder for at least 3 months
- •Failure on primary OAB treatment, such as behavior modification or fluid/diet management
- •Patients can remain on stable medication
- •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
- •Urinary retention or post voiding residual greater than 100 ml
- •Clinically significant bladder outlet obstruction
- •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.
- •Pelvic surgery (such as sub-urethral sling, pelvic floor repair) within the past 6 months
- •Denovo OAB following pelvic surgery sub-urethral sling Intravesical or urethral sphincter Botulinum Toxin Type A injections within the past 6 months
- •Percutaneous Tibial Nerve Stimulation (PTNS) therapy for overactive bladder within the past 6 months
- •Any form of electric stimulation to the pelvis or lower limbs within 4 weeks
- •Vaginal prolapse greater than Stage II in the anterior compartment of the vagina using International Continence Society (ICS) Pelvic Organ ProlapseQuantification (POPQ) criteria.
- •Prior periurethral or transurethral bulking agent injections for bladder problems within the past 12 months.
- •History of pelvic radiation therapy
- •Any skin conditions affecting treatment sites
- •Lacking dexterity to properly utilize the components of the stimulator system.
- •Presence of an implanted electro-medical device (e.g. pacemaker, defibrillator, InterStim®, etc.),
- •Pregnant, nursing, suspected to be pregnant (by urine pregnancy method), or plans to become pregnant during the course of the study.
- •Recurrent Urinary Tract Infections UTI (>3 UTI's in the past year)
- •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
- •Any other clinical trial within 6 months
结局指标
主要结局
Change in Patient Perception of Bladder Condition (PPBC)
时间窗: baseline, 4 weeks
Change in the patient's bladder condition based on the PPBC questionaire from baseline to after 4 weeks of the treatment.
Change in frequency of voiding
时间窗: baseline, 4 weeks
The change of urinary frequency from baseline to after 4 weeks of the treatment, measured by a 3 days bladder diary.
次要结局
- Change in urinary symptoms score and bother symptom score based on the ICIQ-OAB questionnaire(baseline, 4 weeks)
- Changes in symptom severity score and health-related quality of life score (HRQL) based on OAB-questionnaire(baseline, 4 weeks)
- Changes in the mental/physical scores of RAND36(baseline, 4 weeks)
研究者
研究点 (2)
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