The Effect Of Acute Pudendal Nerve Stimulation On Leak Point Pressure In Women Urodynamic: Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
研究概览
简要总结
The purpose of this study is tp evaluate the changes in stress induced Urethral Leak Point Pressures (LPP) and other urodynamic measurements in response to acute pudendal nerve stimulation (PNS) in patients with a pre-existing implanted urological neurostimulator stimulating the pudendal nerve.
详细描述
Patients with a neurostimulator implanted at the pudendal nerve will be enrolled and undergo urodynamic testing. Before testing, study staff will provide an oral antibiotic (to reduce the risk of infection) and adjust the stimulation settings with a goal to increase urethral pressure from baseline by at lest 20cm H2O, without causing the patient discomfort/distress. These settings will be used throughout urodynamics. Before filling the bladder, a urethral pressure profile study will be completed 3 times with stimulation off, then 3 times with stimulation on. Leak point pressure (LPP) testing will then be completed. The patient's bladder will be filled following standard urodynamic testing protocol. Filling will be paused every 50-100mL to complete LPP assessment. Subjects will be asked to complete a light cough, medium cough, forceful cough, and Valsalva maneuver (in that order). Detrusor pressure will be measured at each event, and staff will document whether or not a leak was elicited. This will be completed with stimulation off, then with stimulation on, as the bladder is filled. Once the subject reports a strong urge to void, urethral pressure profile assessment will be completed again: 3 times with stimulation off, then 3 times with stimulation on. Once urodynamic testing is complete and the patient's bladder is emptied, a measurement of urethral pressure will be completed with stimulation off, then during 5 seconds of stimulation, then again with stimulation off.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between the ages of 18 and 85 years old, inclusive.
- •Implanted with a neurostimulation device for at least 3 months prior to consent (Medtronic Interstim neurostimulator models 3023, 3058, 97810, or similar).
- •Implanted with a tined lead that is placed and functionable at the pudendal nerve (Medtronic model 3889 or similar).
- •Is capable of understanding clinical study procedures and giving informed consent.
- •Willing and able to visit the clinic for the UDT evaluation (study procedure)
排除标准
- •Medically unstable at time of study and unsafe to undergo urodynamic testing as determined by the investigator.
- •History of bladder cancer.
- •History of pelvic radiotherapy.
- •Active gross hematuria.
- •Active symptomatic urinary tract infection (UTI)
- •Active symptomatic uncontrolled bladder instability as determined by the investigator.
- •History or symptoms of cystocele, enterocele, or rectocele of grade 3 or
- •Per the medical record or as determined by the investigator.
- •Presence of an artificial urinary sphincter.
- •Women who are pregnant and/or have given birth in the previous 12 months
- •Any medical condition that would interfere with the patient's ability to comply with the protocol and/or may affect the outcome of this study or safety of the subject as determined by the investigator
- •BMI greater than 39.
结局指标
主要结局
Pulse Amplitude Triggering Patient Sensation at First Verbally Reported Sensation.
时间窗: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse amplitude, measured in mA, when subject first verbalizes sensation. Pulse amplitude is the amplitude of the electric pulses; measured in Milliamps (mA). This is a setting present on the neuromodulation device, it is not calculated.
Pulse Frequency Triggering Patient Sensation at First Verbally Reported Sensation.
时间窗: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse frequencies, measured in Hz, when subject first verbalizes sensation.
Pulse Width Triggering Patient Sensation at First Verbally Reported Sensation.
时间窗: After Visit 2 activities are complete. An average of 30 days after enrollment.
PNS final settings including: pulse widths, measured in µs, when the subject first verbalizes sensation.
Identification of All Study-related Adverse Events
时间窗: After Visit 2 activities are complete. An average of 30 days after enrollment.
Safety and tolerability will be assessed in relation to the incidence of study related adverse events reported.
Changes in Leak Point Pressure (LPP) Upon Acute PNS
时间窗: After Visit 2 activities are complete. An average of 30 days after enrollment.
Measurement of the change in LPP with acute PNS compared to without stimulation. To assess LPP, the urethral pressure increase will be calculated by subtracted pressure with and without stimulation at the "final setting". In cm water.
次要结局
- Effect of Acute PNS on the Urethral Pressure Profile (UPP).(After Visit 2 activities are complete. An average of 30 days after enrollment.)
- Effect of Acute PNS on Max Cystometic Capacity.(After Visit 2 activities are complete. An average of 30 days after enrollment.)
- Effect of Acute PNS on Post Void Residual.(After Visit 2 activities are complete. An average of 30 days after enrollment.)
研究者
Kenneth M Peters, MD
Director and Chair of the Department of Urology
William Beaumont Hospitals