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

NCT07711977 — Not applicable, Not yet recruiting, 324 participants, Obstetrics & Gynecology Hospital of Fudan University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07711977, acronym APOUR
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	324 (Estimated)
Sponsor	Obstetrics & Gynecology Hospital of Fudan University (Other); collaborators: Fudan University, RenJi Hospital, Jiaxing Maternity and Child Health Care Hospital
Conditions	Postoperative Urinary Retention (POUR)
Interventions	Acupuncture, Sham acupuncture (Procedure)
Dates	start 2026-07-01 (estimated), primary completion 2028-06-30 (estimated), completion 2028-12-31 (estimated), first posted 2026-07-17, last updated 2026-07-17

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Acupuncture	Experimental	Procedure: Acupuncture
Sham acupuncture	Placebo comparator	Procedure: Sham acupuncture

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.

+Outcome measures

Primary outcomes

Post-void residual urine volume (PVR) [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

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

+Eligibility

Sex: Female, ages: 18 Years to any

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.