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NCT Number: NCT07235371

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

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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Key information

Conditions

Postoperative Urinary Retention (POUR)

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location status: Recruiting

Location contact

Chao Lu

CONTACT

[email protected]

15869128904

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: TEAS

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.

Other names: Sham TEAS

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Safety Assessment

    Time frame: week 2 （after intervention）, and week 4 (follow-up)

    Evaluate based on the Adverse Event Scale.

Other outcomes

  1. Participant Expectation Value Evaluation

    Time frame: week 0 (baseline)

    Evaluate based on the participant's expected value scale

  2. Blinding evaluation

    Time frame: week 2（after intervention）

    Evaluate according to the established blind assessment questionnaire

  3. Participant compliance assessment

    Time frame: week 2 （after intervention）and week 4（follow-up）

    Evaluate based on the participant compliance assessment scale

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Lu

CONTACT

[email protected]

15869128904

Sponsors and collaborators

Lead sponsor

Lu Chao

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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