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

Evaluation of the Efficacy of Acupuncture Combined With Intermittent Catheterization for Postoperative Urinary Retention Due to Neurogenic Bladder 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Urinary Retention (POUR)
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 324
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture	Procedure: Acupuncture; 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.
Placebo Comparator: Sham acupuncture	Procedure: Sham acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-void residual urine volume (PVR)	Measured via B-mode ultrasound after spontaneous voiding following catheter removal and ingestion of approximately 1000 ml of water.	pre-intervention，immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voiding diary	Standardized recording of urinary frequency, volume, and symptom patterns over a defined period.	pre-intervention，immediately after the intervention
Maximum urinary flow rate (Qmax)	Peak flow rate during voiding, obtained via urodynamic assessment.	pre-intervention，immediately after the intervention
First desire to void (FDV)	Volume of urine in the bladder at the initial sensation of needing to urinate, obtained via urodynamic assessment.	pre-intervention，immediately after the intervention
International Consultation on Incontinence Questionnaire - Female Lower Urinary Tract Symptoms Long Form	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.	pre-intervention，immediately after the intervention

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University
• Collaborators: Fudan University; RenJi Hospital; Jiaxing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; radical hysterectomy; postoperative urinary retention
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: FUOBGY-2025-200; 2025YFC3508302 (Other Grant/Funding Number: National Key Research and Development Program of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No