Transcutaneous Electrical Acupoint Stimulation for Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

February 5, 2026 updated by: Lu Chao

Transcutaneous Electrical Acupoint Stimulation on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer: A Randomized Controlled Trial

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Age range of 18-70 years, expected survival period ≥ 6 months; (2) Meets diagnostic criteria, with an indwelling catheter duration of more than 14 days but less than 1 year; (3) No history of urinary system diseases before surgery; (4) Clear consciousness, unobstructed communication, daily living ability, patients or family members can learn TEAS operation; (5) No serious systemic diseases such as heart, liver, brain, kidney, etc; (6) Karnofsky functional status score (KPS) ≥ 70 points; (7) Voluntarily participate and sign a written informed consent form.

Exclusion Criteria:

  • (1) Obstructive urinary retention, such as urethral stricture or stones; (2) combined with other serious systemic diseases, advanced cachexia; (3) Patients with pacemaker implantation or metal implantation in the body; (4) The treatment site has skin lesions or is not suitable for TEAS treatment in other populations; (5) Physical or mental disorders with cognitive impairment; (6) Other clinical trial participants who are currently involved in affecting the results of this study; (7) Those who do not agree to participate in clinical trials; (8) The evaluator has determined that the participant is not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The TEAS Group
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.
Other: transcutaneous electrical acupoint stimulation
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.
Other Names:
  • TEAS
Placebo Comparator: The Sham TEAS Group
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.
Other: Sham transcutaneous electrical acupoint stimulation
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.
Other Names:
  • Sham TEAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in post-void residual (PVR) volume of the bladder
Time Frame: week 2 (after intervention), and week 4 （follow-up）
It will use a direct measurement method to detect residual urine volume in the bladder.
week 2 (after intervention), and week 4 （follow-up）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The response rate of participants who will successfully remove the urinary catheter
Time Frame: week 2 （after intervention）
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）
The proportion of patients who have a urinary tract infection (UTI).
Time Frame: Week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
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
Time Frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）
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
Time Frame: week 2 （after intervention）, and week 4 (follow-up)
Evaluate based on the Adverse Event Scale.
week 2 （after intervention）, and week 4 (follow-up)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Expectation Value Evaluation
Time Frame: week 0 (baseline)
Evaluate based on the participant's expected value scale
week 0 (baseline)
Blinding evaluation
Time Frame: week 2（after intervention）
Evaluate according to the established blind assessment questionnaire
week 2（after intervention）
Participant compliance assessment
Time Frame: week 2 （after intervention）and week 4（follow-up）
Evaluate based on the participant compliance assessment scale
week 2 （after intervention）and week 4（follow-up）

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lu Chao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-2025-1262

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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