NCT03199443Unknown不适用
Pelvic Floor Electromyography Monitoring as Tool to Improve Patient Selection and Outcome - Standardization of Lead Placement for Sacral Neuromodulation.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EMG pelvic floor
研究概览
简要总结
Prospective observational study.
A substantial number of patients do not respond favourably to sacral neurostimulation (SNS) although clinically, they appear to have the same lower urinary tract (LUT) dysfunction characteristics as the good responders. This may be due to methodological issues (lead position) or patient selection. The purpose of this study is to improve and standardize lead position, in order to increase the patient response to test stimulation and to SNS treatment, and to decrease adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female aged ≥18 years and competent to provide consent
- •Minimum 3 months of self-reported OAB symptoms or self-reported obstructive lower urinary tract symptoms (LUTS) in addition to confirmed non-obstructive urinary retention on urodynamics.
- •Failed, or are not a candidate for more conservative treatment (i.e., pelvic floor training, biofeedback, behavioral modification, oral pharmacotherapy)
- •Willing to discontinue OAB medications for 2 weeks prior to the implant and for the entire study period
- •Able to thoroughly fill in all questionnaires, voiding diaries and office visits for device programming and clinical evaluations before the TLP, 3 weeks after TLP and 6 weeks, 6 months and 1 year after implantation of definitive IPG.
排除标准
- •Current of prior evidence of primary stress incontinence or mixed incontinence where the stress component overrides the urgency component
- •Any neurological condition that may interfere with normal bladder function, including stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or spinal cord injury (e.g., paraplegia)
- •Urinary tract mechanical obstruction including but not limited to Benign Prostatic Hyperplasia (BPH)
- •Treatment of bladder or pelvic floor dysfunction with botulinum toxin (Botox ®) or surgery in past 12 months
- •Unable to toilet self and have and maintain good personal hygiene
- •Unable to provide clear, thoughtful responses to questions and questionnaires
- •Urinary tract, bladder or vaginal infection or inflammation
- •Hematuria, and absence of an elaborate diagnostic work-up
- •Severe or uncontrolled diabetes (A1C > 8, documented in the last 3 months) or diabetes with peripheral nerve involvement
- •Allergy to local anesthetic or adhesives
- •Bleeding disorder or on an anticoagulant that cannot be stopped for 3 days before the implant
- •Pregnant, lactating, planning to become pregnant, given birth in the past 12 months, or female of child-bearing potential and not practicing a medically-approved method of birth control
- •Skin lesions or compromised skin at the implant or stimulation site
- •Use of investigational drug or device therapy or participation in any study involving or impacting gynecologic, urinary or renal function within past 4 weeks
- •Passive implants (e.g., prostheses) are allowed, but no implanted metal should be at the Neurostimulator implant site
- •Knowledge of planned magnetic resonance imaging (MRI), diathermy, or high output ultrasonic exposure
- •Presence of a documented condition or abnormality that could compromise the safety of the patient
- •Any psychiatric or personality disorder at the discretion of the study physician
- •Interstitial cystitis or bladder pain syndrome as defined by the guidelines of the European Association of Urology (EAU).
- •Life expectancy of less than 1 year
结局指标
主要结局
EMG pelvic floor
时间窗: 1 day
Latency and amplitude measured by probe
次要结局
- Prevalence of adverse events(2 years)
- Validated questionnaires (KHQ and PeLFis)(1 year)
- Voiding diary(1 year)
研究者
Donald Vaganée
Principal Investigator
Universiteit Antwerpen
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Standardization of Lead Placement for Sacral Neuromodulation. Part 1Non Obstructive Urinary RetentionOveractive BladderNCT03194425Universiteit Antwerpen60
已完成
不适用
Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary IncontinenceUrinary IncontinencePelvic Floor DisordersStress Urinary IncontinenceNCT05624645Pelex5
已完成
Unknown
Evaluation of the effectiveness of biofeedback in the treatment of the respiratory and psychological systems of patients with cervical spinal cord injuryCervical Spinal Cord Injury.Other and unspecified injuries of cervical spinal cordS14.1IRCT20230302057593N1Tehran University of Rehabilitation Sciences and Social Health40
已完成
不适用
Efficacy of Electromyographic Biofeedback, Aerobic Exercise and Stretching in Fibromyalgia.FibromyalgiaNCT03182556Universidad de Almeria89
招募中
不适用
Measuring the electromyographic (EMC) muscle responsepatients receiving neuromuscular blocking agents required for their clinical care during a surgical procedureNL-OMON23335university medical center groningen30