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NCT Number: NCT07711977

Efficacy of Acupuncture for Postoperative Urinary Retention Following Radical Hysterectomy for Cervical Cancer

The goal of this clinical trial is to learn if acupuncture works to treat postoperative urinary retention in patients who have undergone radical hysterectomy for cervical cancer. The main question it aims to answer is:

Does acupuncture lower the volume of post-void residual in participants who need to use intermittent catheterization to assist with voiding after radical hysterectomy for cervical cancer?

Researchers will compare acupuncture to sham acupuncture (non-penetrating needles: using placebo needles with a blunt tip that gives the sensation of skin penetration without actually piercing the skin) to see if acupuncture works to treat postoperative urinary retention.

Participants will:

1. Receive acupuncture or sham acupuncture or tamsulosin for 2 weeks. 2. Visit the clinic before and after treatment for checkups and tests. 3. Keep a voiding diary and record the volume of post-void residual and the number of times they use intermittent catheterization.

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Key information

Conditions

Postoperative Urinary Retention (POUR)

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with a pathologically confirmed diagnosis of cervical cancer who have undergone radical hysterectomy for cervical cancer.
  • Patients who developed urinary retention after catheter removal during routine postoperative follow-up (2-4 weeks after surgery), with post-void residual urine volume measured by ultrasound exceeding 100 ml on two consecutive occasions.
  • Aged ≥18 years.
  • Patients who are informed and voluntarily sign the informed consent form.
  • Patients with a Karnofsky Performance Status (KPS) score ≥70 .

Exclusion criteria

  • Patients with a clear preoperative diagnosis of urinary retention or voiding dysfunction.
  • Patients with urinary retention caused by conditions other than radical surgery for cervical cancer, such as spinal cord injury or other diseases.
  • Patients with severe heart, lung, or kidney failure, or those with severe medical comorbidities.
  • Patients with a severe bleeding tendency due to any cause.
  • Patients with severe consciousness disorders or psychiatric/psychological conditions that preclude cooperation with treatment.

Treatment and study plan

Acupuncture

Procedure

Participants receive acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). Acupoints selected: Zhongji (CV3), Yinlingquan (SP9), Sanyinjiao (SP6), Ciliao (BL32), Zhongliao (BL33), Pangguangshu (BL28), Zhibian (BL54). Treatment lasts for 2 weeks.

Sham acupuncture

Procedure

Participants receive sham acupuncture treatment in addition to intermittent catheterization and an α-blocker (e.g., tamsulosin). The same acupoints as in the acupuncture group are selected. Sham acupuncture method: using a placebo needle device with a blunt tip that gives the sensation of skin penetration without actually piercing the skin. Treatment lasts for 2 weeks.

Primary outcomes

  1. Post-void residual urine volume (PVR)

    Time frame: pre-intervention，immediately after the intervention

    Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.

Secondary outcomes

  1. Voiding diary

    Time frame: pre-intervention，immediately after the intervention

    Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.

  2. Maximum urinary flow rate (Qmax)

    Time frame: pre-intervention，immediately after the intervention

    Peak flow rate during voiding, obtained via urodynamic assessment.

  3. First desire to void (FDV)

    Time frame: pre-intervention，immediately after the intervention

    Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.

  4. International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form

    Time frame: pre-intervention，immediately after the intervention

    International Consultation on Incontinence Questionnaire for Female Lower Urinary Tract Symptoms (long form), used to quantify symptom burden and quality of life impact. The minimum value of the questionnaire is 0 and the maximum value is 69. Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University

Other

Collaborators

  • Fudan University
  • Jiaxing Maternity and Child Health Care Hospital
  • RenJi Hospital

Registry information

Official study title

Evaluation of the Efficacy of Acupuncture Combined With Intermittent Catheterization for Postoperative Urinary Retention Due to Neurogenic Bladder Following Radical Hysterectomy for Cervical Cancer

Acronym: APOUR

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 17, 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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