Evaluation of the Efficacy of Acupuncture Combined With Intermittent Catheterization for Postoperative Urinary Retention Due to Neurogenic Bladder Following Radical Hysterectomy for Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 324
- 主要终点
- Post-void residual urine volume (PVR)
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture works to treat postoperative urinary retention in patients who have undergone radical hysterectomy for cervical cancer. The main question it aims to answer is:
Does acupuncture lower the volume of post-void residual in participants who need to use intermittent catheterization to assist with voiding after radical hysterectomy for cervical cancer?
Researchers will compare acupuncture to sham acupuncture (non-penetrating needles: using placebo needles with a blunt tip that gives the sensation of skin penetration without actually piercing the skin) to see if acupuncture works to treat postoperative urinary retention.
Participants will:
- Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks.
- Visit the clinic before and after treatment for checkups and tests.
- Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with a pathologically confirmed diagnosis of cervical cancer who have undergone radical hysterectomy for cervical cancer.
- •Patients who developed urinary retention after catheter removal during routine postoperative follow-up (2-4 weeks after surgery), with post-void residual urine volume measured by ultrasound exceeding 100 ml on two consecutive occasions.
- •Aged ≥18 years.
- •Patients who are informed and voluntarily sign the informed consent form.
- •Patients with a Karnofsky Performance Status (KPS) score ≥70 .
排除标准
- •Patients with a clear preoperative diagnosis of urinary retention or voiding dysfunction.
- •Patients with urinary retention caused by conditions other than radical surgery for cervical cancer, such as spinal cord injury or other diseases.
- •Patients with severe heart, lung, or kidney failure, or those with severe medical comorbidities.
- •Patients with a severe bleeding tendency due to any cause.
- •Patients with severe consciousness disorders or psychiatric/psychological conditions that preclude cooperation with treatment.
结局指标
主要结局
Post-void residual urine volume (PVR)
时间窗: pre-intervention，immediately after the intervention
Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.
次要结局
- Voiding diary(pre-intervention，immediately after the intervention)
- Maximum urinary flow rate (Qmax)(pre-intervention，immediately after the intervention)
- First desire to void (FDV)(pre-intervention，immediately after the intervention)
- International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form(pre-intervention，immediately after the intervention)