Postoperative Urinary Retention (POUR)
Conditions
Keywords
acupuncture, radical hysterectomy, postoperative urinary retention
Brief summary
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.
Interventions
PROCEDUREAcupuncture
Participants 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.
PROCEDURESham acupuncture
Participants 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.
Sponsors
Obstetrics & Gynecology Hospital of Fudan University
Fudan University
RenJi Hospital
Jiaxing Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 .
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-void residual urine volume (PVR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Voiding diary | pre-intervention，immediately after the intervention | Standardized recording of urinary frequency, volume, and symptom patterns over a defined period. |
| Maximum urinary flow rate (Qmax) | pre-intervention，immediately after the intervention | Peak flow rate during voiding, obtained via urodynamic assessment. |
| First desire to void (FDV) | pre-intervention，immediately after the intervention | 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 | pre-intervention，immediately after the intervention | 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. |
Outcome results
None listed