Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

Lu Chao

Status: Not yet enrolling

Conditions: Postoperative Urinary Retention (POUR)

Treatments: Other: Sham EA intervention; Other: EA intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07253194

IRB-2025-1315

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups

The EA Group

Experimental group

Description:

Participants will receive the EA intervention for two consecutive weeks.

Treatment:

Other: EA intervention

The sham EA Group

Sham Comparator group

Description:

Participants will receive the sham EA intervention for two consecutive weeks.

Treatment:

Other: Sham EA intervention