NCT06158074已完成不适用
Efficacy of Electrical Pudendal Nerve Stimulation and Sacral Neuromodulation in Treating Non-obstructive Neurogenic Urinary Retention: A Nonrandomized Clinical Trial
Shanghai Institute of Acupuncture, Moxibustion and Meridian2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Percent change in pre-post treatment post-voiding residual urine volume (PVR )
研究概览
简要总结
To observe the clinical effects and make a comparative study between efficacy of electrical pudendal nerve stimulation (EPNS) and sacral neuromodulation (SNM) , evaluate the advantages of EPNS in the treatment of neurogenic non-obstructive urinary retention, and provide a new method for the treatment of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-mechanical obstructive urinary retention occurs following relevant neurological system disorders (spinal cord injury, spina bifida，myelitis, cervical/thoracic disk disease, lesion following spinal anesthesia/spine surgery,lumbar/sacral spine intervertebral disc diseases, spinal stenosis, iatrogenic pelvic nerve lesions, sacral agenesis, peripheral neuropathy due to diabetes mellitus).
- •With normal upper urinary tract function.
- •Other therapies and medications potentially affecting the assessment of this therapy have been discontinued for at least two weeks before the interventional procedure.
- •Patient with good compliance who is capable of cooperating with the follow-up requirements
排除标准
- •Patients with any suprapontine and pontine lesions
- •Pregnant or lactating women
- •Individuals whose symptoms show significant improvement after pharmaceutical and adjunctive therapy
- •Individuals with concurrent acute or chronic prostatitis, prostate cancer, or conditions such as bladder neck stenosis, urethral stricture, or urethral injury
- •High pathological risk factors (e.g., lymph node metastasis, resection margin involvement, bulky tumors)
- •Individuals with concomitant obstructive urinary retention
结局指标
主要结局
Percent change in pre-post treatment post-voiding residual urine volume (PVR )
时间窗: baseline (T0), mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM)
Bladder PVR is measured by ultrasound.Percent change in pre-post treatment PVR is calculated as (baseline PVR - post-treatment PVR) / baseline PVR × 100%.
次要结局
- Absolute post-voiding residual volume (PVR) at the end of treatment; International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms (ICIQ-LUTS) and the quality of life (ICIQ-LUTSqol) score.(Mid-treatment (T1; after 6 EPNS sessions or 2 weeks of SNM), and (T2; after 12 EPNS sessions or 4 weeks of SNM))
研究者
研究点 (2)
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