Utilization of Percutaneous Tibial Nerve Stimulation During Office-Based Cystoscopy: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Patient Discomfort
研究概览
简要总结
This study will be a double-blind, randomized control trial, with one additional unblinded arm. This study has been designed to identify a means of improving quality of life for patients requiring in-office cystoscopy. Percutaneous tibial nerve stimulation (PTNS) has been shown to improve quality of life and symptom control in multiple urological conditions based on shared neuroanatomical structures between the genitourinary system and the tibial nerve The goal of this project is to demonstrate the efficacy and safety of PTNS in minimizing patient discomfort during cystoscopy to develop a larger randomized control trial in the near future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This study will be a double-blind, randomized control trial, with one additional unblinded arm. The two blinded arms will be PTNS and sham PTNS, with the additional unblinded arm being standard of care
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
- •Patients 18 years of age or older
- •Patients undergoing routine office-based cystoscopy by a urology provider
排除标准
- •Patients for whom ancillary procedures are performed during cystoscopy, including ureteral stent removal, bladder stone removal, biopsy, or fulguration
- •Patients undergoing cystoscopy due to concern for urologic injury
- •Patients undergoing cystoscopy due to concern for prosthetic abnormality, including erosion or malposition
- •Patients who perform clean intermittent catheterization
- •Patients with pre-existing neurological pathology, including but not limited to multiple sclerosis, spinal cord injury, Parkinson's disease, or peripheral neuropathy of any etiology
- •Patients having undergone prior non-endoscopic prostatectomy (radical prostatectomy, simple prostatectomy)
- •Patients with a history of interstitial cystitis/chronic pelvic pain
- •Patients who have taken an analgesic (excluding 81mg aspirin) in the past 12 hours
- •Patients with a history of urethral stricture disease
结局指标
主要结局
Patient Discomfort
时间窗: One year
To assess the ability of percutaneous tibial nerve stimulation to improve patient discomfort during routine office-based cystoscopy based on a 10-point visual analogue scale (VAS) by comparing median and interquartile ranges between groups. A score of 0 will indicate no pain whereas a score of 10 indicates the worst pain imaginable.
次要结局
- Safety of PTNS: adverse events(One year)
研究者
Jeffrey Holzbeierlein
Principal Investigator
University of Kansas Medical Center