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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The TEAS Group | Experimental | 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. |
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| The Sham TEAS Group | Placebo Comparator | Participants will receive sham TEAS treatment once a day for two consecutive weeks. The operation of the sham TEA group will be consistent with that of the TEAS group, with a current intensity set to 30mA. 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous electrical acupoint stimulation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | week 2 (after intervention), and week 4 (follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 2 (after intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Expectation Value Evaluation | Evaluate based on the participant's expected value scale | week 0 (baseline) |
| Blinding evaluation | Evaluate according to the established blind assessment questionnaire |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Lu | Contact | 15869128904 | luchao@zjcc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| Sham transcutaneous electrical acupoint stimulation | Other | 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. |
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| 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. | 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. | week 0 (baseline), week 2 (after intervention), and week 4 (follow-up) |
| Safety Assessment | Evaluate based on the Adverse Event Scale. | week 2 (after intervention), and week 4 (follow-up) |
| week 2(after intervention) |
| Participant compliance assessment | Evaluate based on the participant compliance assessment scale | week 2 (after intervention)and week 4(follow-up) |