Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• The response rate of participants who will successfully remove the urinary catheter [Срок оценки: week 0（baseline），and week 2 (after intervention)]

Вторичные конечные точки (3)

• The changes in PVR volume. [Срок оценки: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]
• Assessment of UTI. [Срок оценки: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]
• Assessment of patient quality of life. [Срок оценки: week 0 (baseline), week 2 (after intervention), and week 4 （follow-up）]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT07253194 · IRB-2025-1315

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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