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| ID | Type | Description | Link |
|---|---|---|---|
| 2025YFC3508302 | Other Grant/Funding Number | National Key Research and Development Program of China |
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| Name | Class |
|---|---|
| Fudan University | OTHER |
| RenJi Hospital | OTHER |
| Jiaxing Maternity and Child Health Care Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental |
| |
| Sham acupuncture | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | pre-intervention,immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Voiding diary | Standardized recording of urinary frequency, volume, and symptom patterns over a defined period. | pre-intervention,immediately after the intervention |
| Maximum urinary flow rate (Qmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham acupuncture | Procedure | 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. |
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Peak flow rate during voiding, obtained via urodynamic assessment.
| pre-intervention,immediately after the intervention |
| First desire to void (FDV) | Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment. | pre-intervention,immediately after the intervention |
| 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. | pre-intervention,immediately after the intervention |