Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

NCT ID: NCT07253194

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Postoperative Urinary Retention (POUR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

The EA Group

Participants will receive the EA intervention for two consecutive weeks.

Group Type: EXPERIMENTAL

EA intervention

Intervention Type: OTHER

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 sides of the spine at a frequency of 2 Hz and a stimulation intensity of 2 ± 1.5 mA. Each treatment will last for 30 minutes, 5 days per week, for 2 weeks. Follow-up will be performed 2 weeks after the final treatment.

The sham EA Group

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

Group Type: SHAM_COMPARATOR

Sham EA intervention

Intervention Type: OTHER

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 device, as the connecting wires will undergo specialized modification. Each treatment session will also last 30 minutes, 5 days per week, for 2 weeks. The Follow-up will also be performed 2 weeks after the final treatment.

Interventions

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 sides of the spine at a frequency of 2 Hz and a stimulation intensity of 2 ± 1.5 mA. Each treatment will last for 30 minutes, 5 days per week, for 2 weeks. Follow-up will be performed 2 weeks after the final treatment.

Intervention Type: 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 device, as the connecting wires will undergo specialized modification. Each treatment session will also last 30 minutes, 5 days per week, for 2 weeks. The Follow-up will also be performed 2 weeks after the final treatment.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Lu Chao

OTHER

Sponsor Role: lead

Responsible Party

Lu Chao

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Chao Lu

Role: CONTACT

1069103617@qq.com

15869128904

Other Identifiers

IRB-2025-1315

Identifier Type: -

Identifier Source: org_study_id