About this trial
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:
1. Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks. 2. Visit the clinic before and after treatment for checkups and tests. 3. Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Acupuncture
Procedure/SurgeryParticipants receive acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). Acupoints selected: Zhongji (CV3), Yinlingquan (SP9), Sanyinjiao (SP6), Ciliao (BL32), Zhongliao (BL33), Pangguangshu (BL28), Zhibian (BL54). Treatment lasts for 2 weeks.
Sham acupuncture
Procedure/SurgeryParticipants receive sham acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). The same acupoints as in the acupuncture group are selected. Sham acupuncture method: using a placebo needle device with a blunt tip that gives the sensation of skin penetration without actually piercing the skin. Treatment lasts for 2 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Post-void residual urine volume (PVR)
Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.
Secondary outcomes
Voiding diary
Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.
Maximum urinary flow rate (Qmax)
Peak flow rate during voiding, obtained via urodynamic assessment.
First desire to void (FDV)
Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form
International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms (long form), used to quantify symptom burden and quality of life impact. The minimum value of the questionnaire is 0 and the maximum value is 69. Higher scores mean a worse outcome.
Locations
Sponsors and contacts
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Obstetrics & Gynecology Hospital of Fudan University
Lead sponsor
Fudan University
Collaborator
RenJi Hospital
Collaborator
Jiaxing Maternity and Child Health Care Hospital
Collaborator
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