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Not yet recruiting NCT07253194

Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

No phase Interventional Postoperative Urinary Retention (POUR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EA intervention, Sham EA intervention.
Who it may be relevant to
Registry conditions: Postoperative Urinary Retention (POUR). Basic parameters: 18 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer： A Randomized Controlled Trial

Overview

This is a prospective, blinded, single-center, randomized controlled trial. Investigators will include 208 patients with postoperative urinary retention (POUR) after radical hysterectomy for cervical cancer who have a clear diagnosis and meet the screening criteria. Participants will be randomly divided into the electroacupuncture（EA）group and the sham EA group according to a 1:1 ratio. Each group consists of 104 patients, and all participants will be required to sign a written informed consent form. The TEAS group will be treated with EA based on conventional treatment, and the shamEA group will be treated with sham EA based on conventional treatment. The main outcomes will be to calculate the proportion of patients who successfully removed the urinary catheter, and the secondary indicators will include the change in post-void residual (PVR) volume of the bladder, assessment of urinary tract infection (UTI), and quality of life assessment according to the EORTC QLQ-C30 scale. Evaluation of participant-reported expectations, blinding, compliance, and safety will also be conducted. All analyses will be conducted in accordance with the intention-to-treat principle.

Interventions

  • Other EA intervention
    Participants will undergo EA treatment. Acupoint selection: Shenshu(BL23), Pangguanghu (BL28), Ciliao (BL32), Zhongliao (BL33), Huiyang (BL35), and Zhibian (BL54). Acupuncture needles (0.30 × 50 mm) will be vertically inserted into BL32, BL23, BL28, and BL35 at a depth of 40 ± 8 mm. The disposable acupuncture needle (0.45 × 75 mm) will be inserted into BL54 at a depth of 55 ± 10 mm, with the direction of insertion toward Shuidao (ST28). EA will be applied to the BL32 and BL54 points on both side
  • Other Sham EA intervention
    Participants will receive sham EA treatment. Acupoint selection: consistent with the EA group. Sham acupuncture procedure: The disposable acupuncture needle (0.25 × 40 mm) will be used, and all acupoints will be shallowly penetrated into the skin using a vertical method, with a needle depth of 5 ± 2 mm. Sham EA application: EA electrodes will be attached identically to the EA group at a frequency of 2 Hz and a nominal intensity of 2 mA. However, no electrical current will be delivered via the EA

Primary outcome measures

  • The response rate of participants who will successfully remove the urinary catheter [Time frame: week 0（baseline），and week 2 (after intervention)]
Secondary outcome measures (3)
  • The changes in PVR volume. [Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]
  • Assessment of UTI. [Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]
  • Assessment of patient quality of life. [Time frame: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]

Eligibility criteria

Inclusion criteria

  • ① 18 to 70 years old;
  • ② Anticipated survival of at least 6 months;
  • ③ Met the diagnostic criteria for POUR of cervical cancer, and the duration of POUR is less than 6 months;
  • ④ No serious urinary system disease in the past, and no urinary retention before operation;
  • ⑤ Karnofsky functional status score (KPS) ≥ 70 points;
  • ⑥ Stable vital signs, no serious mental illness, capable of daily living, able to cooperate in completing all treatments and examinations;
  • ⑦ Voluntarily participate and sign a written informed consent form.

Exclusion criteria

  • ① Obstructive urinary retention, such as urethral stricture or stones induced urinary system diseases;
  • ② Merge other serious systemic diseases, and advanced cachexia patients;
  • ③ Patients who are intolerant to electrical stimulation therapy, such as those with pacemakers installed;
  • ④ With psychiatric disorder or severe cognitive impairment;
  • ⑤ Severe skin damage, infection, and ulceration at the treatment site;
  • ⑥ Those who are participating in other acupuncture or drug clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Lu C, Chen N, Sun H, Wang C, Zhao L, Bao W, Deng D, Wang P, Li X. Effect of Electroacupuncture on Postoperative Urinary Retention After Radical Hysterectomy for Cervical Cancer: Study Protocol for A Randomized Controlled Trial. J Pain Res. 2026 Mar 18;19:598960. doi: 10.2147/JPR.S598960. eCollection 2026. PMID 41878088

Identifiers

NCT: NCT07253194 · IRB-2025-1315

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗