Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer： A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- The response rate of participants who will successfully remove the urinary catheter
研究概览
简要总结
This is a prospective, blinded, single-center, randomized controlled trial. Investigators will include 208 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria. Participants will be randomly divided into the electroacupuncture（EA）group and the sham EA group according to a 1:1 ratio. Each group consists of 104 patients, and all participants will be required to sign a written informed consent form. The TEAS group will be treated with EA based on conventional treatment, and the shamEA group will be treated with sham EA based on conventional treatment. The main outcomes will be to calculate the proportion of patients who successfully removed the urinary catheter, and the secondary indicators will include the change in post-void residual (PVR) volume of the bladder, assessment of urinary tract infection (UTI), and quality of life assessment according to the EORTC QLQ-C30 scale. Evaluation of participant-reported expectations, blinding, compliance, and safety will also be conducted. All analyses will be conducted in accordance with the intention-to-treat principle.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •① 18 to 70 years old;
- •② Anticipated survival of at least 6 months;
- •③ Met the diagnostic criteria for POUR of cervical cancer, and the duration of POUR is less than 6 months;
- •④ No serious urinary system disease in the past, and no urinary retention before operation;
- •⑤ Karnofsky functional status score (KPS) ≥ 70 points;
- •⑥ Stable vital signs, no serious mental illness, capable of daily living, able to cooperate in completing all treatments and examinations;
- •⑦ Voluntarily participate and sign a written informed consent form.
排除标准
- •① Obstructive urinary retention, such as urethral stricture or stones induced urinary system diseases;
- •② Merge other serious systemic diseases, and advanced cachexia patients;
- •③ Patients who are intolerant to electrical stimulation therapy, such as those with pacemakers installed;
- •④ With psychiatric disorder or severe cognitive impairment;
- •⑤ Severe skin damage, infection, and ulceration at the treatment site;
- •⑥ Those who are participating in other acupuncture or drug clinical trials.
研究组 & 干预措施
The EA Group
Participants will receive the EA intervention for two consecutive weeks.
干预措施: EA intervention (Other)
The sham EA Group
Participants will receive the sham EA intervention for two consecutive weeks.
干预措施: Sham EA intervention (Other)
结局指标
主要结局
The response rate of participants who will successfully remove the urinary catheter
时间窗: week 0（baseline），and week 2 (after intervention)
The participants in each group who will remove their urinary catheters after intervention, in proportion to the total number of patients in each group, multiplied by 100%. It can also be understood as the initial cure rate of POUR. The standard for patients to remove the urinary catheter is that the PVR volume is less than 100ml.
次要结局
- The changes in PVR volume.(week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）)
- Assessment of UTI.(week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）)
- Assessment of patient quality of life.(week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）)
研究者
Lu Chao
Clinical Professor
Zhejiang Cancer Hospital