This is a prospective, blinded, single-center, randomized controlled trial. We will include 76 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria as the research object. They will be randomly divided into the transcutaneous electrical acupoint stimulation（TEAS）group and the sham TEAS group according to a 1:1 ratio. Each group consists of 38 patients, and all patients will be required to sign a written informed consent form. The TEAS group will be treated with TEAS based on conventional treatment, and the sham TEAS group will be treated with shamTEAS based on conventional treatment. The main outcomes will be the changes in post-void residual (PVR) volume; secondary indicators will include the response rate of participants with successful urinary catheter removal after intervention, assessment of urinary tract infection (UTI), and patient quality of life assessment according to the EORTC QLQ-C30 scale. The participants will also be evaluated with expectations, blind evaluation, compliance evaluation, and safety evaluation to preliminarily evaluate the effect of TEAS for postoperative urinary retention after radical hysterectomy for cervical cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
Participants will receive TEAS treatment once a day for two consecutive weeks. TEAS stimulation: A set of TEAS patch stimulation will be applied to BL32 and BL34 points on both sides of the spine respectively, with an intensity of approximately 30 ± 5mA, based on patient tolerance. The frequency will be 2/10Hz.
Participants will receive sham TEAS treatment once a day for two consecutive weeks. The operation of the sham TEAS group will be consistent with that of the TEAS group, with a current intensity set at 30 mA. However, the instrument circuit of the fake TEAS group cannot output current normally, and participants can only feel patches stimulating at the BL32 and BL34 acupoints.
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGThe change in post-void residual (PVR) volume of the bladder
It will use a direct measurement method to detect residual urine volume in the bladder.
Time frame: week 2 (after intervention), and week 4 （follow-up）
The response rate of participants who will successfully remove the urinary catheter
The participants in each group who will remove their urinary catheters after intervention (week 2), 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.
Time frame: week 2 （after intervention）
The proportion of patients who have a urinary tract infection (UTI).
Determine whether the patient has a urinary tract infection based on their urine routine test or urine culture test results.
Time frame: Week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
The evaluation of the quality of life
Assessing patients' quality of life using the EQRTC QLQ-C30 scale.
Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
Safety Assessment
Evaluate based on the Adverse Event Scale.
Time frame: week 2 （after intervention）, and week 4 (follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.